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    WSLH PT Policies

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    =,/3,%V1:I%#.T%',.1)1)>%.)/X+,%#.T%?+-@3:3)2A%W?+/3Z%&'EJHK8Y p6KK

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    &03.43%2+):.2:%P4%.:%EKK7;B675

    Online Training and Competency

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    '+%+,/3,Z%%%%%%%%R43%*+,-%1)%:I14%2.:.0+>%+,%*,+-%+P,%V3T41:3%.:%VVV5V40I@:5+,>%W43032:%&'1-'#%=)01)3%.)/%:I3)%&,121)>%=,/3,%()*+5

    O.b%2+-@03:3/%+,/3,%*+,-%:+%BKE76B%-3:I+/45

    %?+/3Z &'E6KKK

    &,123Z pJ3)4%7%()"P3)N.

    'I14%@,+/P2:%@,+G1/34%.%43:%+*%!B7%4.-@034%1)20P/1)>%@+41G3%1)"P3)N.%S\%@+41G3%1)"P3)N.%L%.)/%

    )3>.G3%4.-@0345

    ?+/3Z &'E6JKK

    &,123Z p6KK

    D1,.0%S)>3)4%7%U"D

    'I14%@,+/P2:%@,+G1/34%.%43:%+*%!B7%4.-@034%1)20P/1)>%@+41G3%.)/%)3>.G3%4.-@034%*+,%U"D5 %?+/3Z &'E66KK

    &,123Z p6KKM,.-%":.1)

    'I14%@,+/P2:%@,+G1/34%.%43:%+*%!B7%P)4:.1)3/%401/34%*+,%P43%1)%.443441)>%T+:I%>,.-%4:.1)%:32I)1]P3%

    .)/%+,>.)14-%-+,@I+0+>A5

    ?+/3Z &'E68KK

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    G&'H/I29DJ&?C/C97=>'8/D6'%>=2E;

    %% U3]P34:3/%4.-@034

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    #.T%-.).>3,4\%:32I)12.0%2+)4P0:.):4%.)/%&=?'%2++,/1).:+,4%.,3%+ 3)%@IA412.00A%,3-+G3/%*,+-%:I3%:34 )>%41:34%*+,%VI12I%:I3A%

    I.G3%,34@+)41T101:A5%%!"#$%&'%+3,4%43,G1234%VI12I%V3%T3013G3%-.Q3%:I3%3),3%&'%@,+2344%-+,3%3%213):5

    ?+@134%+*%&'%U3@+,:4% % % % % % [+%.//1+).0%2+4:?+@134%+*%.00%@,+!213)2A%:34)>%,3@+,:4%43):%:+%:I3%3),+003/%41:3W4Y%.0+)>%V1:I%4:.424%.)/%3G3):%4P--.,A%)+:34%2.)%T3%43):%

    :+%.%:32I)12.0%2+)4P0:.):\%0.T%/1,32:+,\%-.).>3,%+,%&=?'%2++,/1).:+,%1*%:I3%1)*+,-.+)%14%4P@@013/%:+%P45%%'I343%2+@134%V100%T3%

    ,303.43/%+)%:I3%4.-3%-3%*,.-3%.4%:I3%2P4:+-3,%0.T45

    M,+P@%U373),+00-3):% % % [+%.//1+).0%2+4:'I14%43,G123%14%1):3)/3/%:+%4:,3.-01)3%:I3%,373),+00-3):%@,+2344%q%.)/%1:a4%*,33j%%U373),+00-3):%*+,-4%*+,%.00%41:34%2.)%T3%2+-T1)3/%

    1)%.%41)>03%-.101)>%/1,32:0A%:+%+)3%1)/1G1/P.0%,.:I3,%:I.)%3.2I%+*%:I3%0.T%41:345%%'I3%41:34%2.)%T3%1)%:I3%4.-3%I3.0:I%2.,3%4A4:3-%+,%1)%

    /13,3):%4A4:3-4%P)/3,%:I3%+G3,41>I:%+*%.%2+)4P0:.):5%%'I14%4.G34%G.0P.T03%-3%1)%:,.2Q1)>%,373),+00-3):%.)/%3)4P,34%:I.:%.00%41:34%

    V100%T3%3),+003/%1)%@,+!213)2A%:34)>%*+,%:I3%)3V%A3.,5%%

    (*%A+P%.,3%.%2P,,3):%2P4:+-3,%,34@+)41T03%*+,%-P0@03%41:34%.)/%V+P0/%01Q3%:+%:.Q3%./G.):.>3%+*%:I14%43,G123\%@03.43%2.00%!"#$%&'%

    ?P4:+-3,%"3,G123%.:%EKK7;B673%J%+*%:I3%9),+00-3):%O+,-5

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    2+)4P0:.):4%P4P.00A%I.G3%,34@+)41T101:A%*+,%+,>.)1N1)>%/+2P-3):. +)%@,1+,%:+%.22,3/1:.+)%1)4@32+)45%%LA%2I32Q1)>%:I3%*?9:22,

    &:?!9@,&:8C,+@+)\%2+@134%+*%:I3%3),+00-3):%2+)!,-.+)%*+,-4%W1)20P/1)>%41:374@321!2%4I1@-3):%42I3/P034Y%.,3%@,+G1/3/%:+%

    .4414:%A+P%V1:I%:I14%:.4Q5%%F.)A%2+)4P0:.):4%,3231G1)>%:I14%43,G123%!)/%1:%.04+%e20+434%:I3%+,/3,1)>%0++@f%.)/%.44P,34%:I.:%:I3%

    @P,2I.41)>%/3@.,:-3):%I.4%4PT-13/%.00%+,/3,4%.)/%V3%I.G3%2+,,32:0A%@,+23443/%:I3-5%%'I14%43,G123%14%+3,3/%.:%)+%2I.,>35

    `P.01:A%F.).>3-3):%U3@+,:%W`FUY% % % % @7=2;%&'E8KKK%%F9D'2;%p;KK9G3,A%:I,33%-+):I4% A+P%V100%,3231G3%.)% 3032:,+)12%,3@+,:%W9b230%!03%*+,-.:Y%2+):.1)1)>%.00%&'%:34)>%1)*+,-.+)%*+,%A+P,%41:34%

    2+G3,1)>%:I3%-+4:%,323):%:V+%A3.,4%W?P,,3):%2P4:+-3,4%V100%I.G3%:I31,%/.:.%@,37@+@P0.:3/%1):+%:I31,%!,4:%,3@+,:Y5

    'I3%,3@+,:%V100%T3%43):%:+%A+P,%3-.10%.//,344%.)/%2+-34%@,374+,:3/%1):+%*+P,%2.:3>+,134Z

    % "I33:%lJ%r%.00%&'%:34)>%/.:.%4+,:3/%TA%!"#$%&'%2P4:+-3,%)P-T3,%

    % "I33:%l6%r%.).0A:34%TA%41:3XA3.,X3G3):%V1:I%P).223@:.T03%42+,34

    % "I33:%l8%r%.).0A:34%TA%41:3XA3.,X3G3):%V1:I%.223@:.T03%42+,34%TP:%0344%:I.)%JKKs

    % "I33:%l;%r%.).0A:34%,3231G1)>%JKKs%*+,%t[+)72+)43)4P4t\%t[+:%"2+,3/t%+,%t9b2P43%U3]P34:3/t%41:P.+)4

    "2+,1)>%/3:.104%4P2I%.4%e#.:3f%+,%e[+%,34P0:4%,3231G3/f%V100%T3%1)20P/3/%1)%:I3%,3@+,:%:+%I30@%A+P%1/3) *A%.)/%/+2P-3):%:I3%,3.4+)4%

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    14%1):3)/3/%:+%.4414:%1)%@,3@.,.+)%*+,%.)%+)741:3%4P,G3A5%%'I3%,3@+,:%2.)%T3%@,3@.,3/%*+,%41)>03%+,%-P0@03%41:34%[email protected]%@,+G1/3%.%

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    Analytes listed in black are regulated under CLIA 8

    Electrolytes / Metabolites (Waived Methods) (BGW)

    LH922/EHDC?268E/C29/M2&9//+//NDO2/E&?C%2E/C29/EHDC?268/

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    R6&%M82E;$3-+>0+T1)% % % $3-.:+2,1:

    Blood Gas Hemoglobin / Hematocrit - Add-on to BG

    LH922/EHDC?268E/C29/M2&9//+//NDO2/E&?C%2E/C29/EHDC?268

    F97=>'8/P6Q79?&8D76;//6-#%4.-@034%+*%4:.T101N3/%I3-+>0+T1)%4+0P+)5

    R6&%M82E;?.,T+bAI3-+>0+T1)% % F3:I3-+>0+T1)

    $3-+>0+T1)\%:+:.0% % =bAI3-+>0+T1)

    Co-oximetry (CO)

    B9=29/BC8D76E

    F97=>'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

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    R66>&%/F9D'2

    S//7+)%@,+/P2:%7%LM$ &'JKJK8 p;6

    S//1:1+).0%4.-@034 &'JKJKJ p8H

    S//7+)%@,+/P2:%7%LM$[ &'JKJJ8 p;6

    S//1:1+).0%4.-@034 &'JKJJJ p8H

    B9=29/BC8D76E

    F97=>'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2: &'JK6KK p6H;S//1+).0%4.-@034 &'JK6KJ p &'JK6K6 pB8

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    F97=>'8/P6Q79?&8D76;//8-#%4.-@034%4P1:.T03%*+,%.]P3+P4%2I3-14:,A%:34:1)>5%():3)/3/%*+,%V.1G3/%4A4:3-4%4P2I%.4%!"#$%$,F%P41)>%.),!"#$%$,&976E,&G*)HI \%+,%+:I3,%V.1G3/%2.,:,1/>35%%#.T+,.:+,134%P41)>%)+)7V.1G3/%-3:I+/4%4I+P0/%,3*3,%:+%L0++/%M.434%@,+/P2:%014:3/%.T+G35

    R6&%M82E;?.,T+)%/1+b1/3\%:+:.0% % (+)1N3/%2.021P-?I0+,1/3% % % &+:.441P-?,3.)1)3% % % "+/1P-M0P2+43% % % R,3.%)1:,+>3)

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    Analytes listed in black are regulated under CLIA 88. ** Not accepted by the CAP Laboratory Accreditation Program, see page 5 for more information.

    LH922/EHDC?268E/C29/M2&9//+//NDO2/E&?C%2E/C29/EHDC?268

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    R66>&%/F9D'2

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    U3@+,)>%J7B%.).0A:34 &'JJKKK pJ%C7JJ%.).0A:34 &'JJKJK pJCJ

    U3@+,)>%J67JB%.).0A:34 &'JJK6K p66E

    U3@+,)>%JC76J%.).0A:34 &'JJK8K p6C8

    U3@+,)>%6676B%.).0A:34 &'JJK;K p8K8

    U3@+,)>%6C78K%.).0A:34 &'JJK3):%>,./3%V.:3,%.,3%,32+--3)/3/%*+,%,32+)4:P+)5

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    @7=2R66>&%/

    F9D'2

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    S//7+)%@,+/P2:%W:+%?9'Y &'JJ6K8 pB8

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    l%+*%.).0A:34

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    S//1:1+).0%,34P0:4

    J7B &'JJKKJ &'JJKK6

    C7JJ &'JJKJJ &'JJKJ6

    67JB &'JJK6J &'JJK66

    JC76J &'JJK8J &'JJK86

    6676B &'JJK;J &'JJK;6

    6C78K &'JJK

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    ,7*01'.

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    Analytes listed in black are regulated under CLIA 8

    B9=29/BC8D76E

    F97=>'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2: &'J6KKK p6'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2: &'J6JKK pJ;;

    S//1+).0%4.-@034 &'J6JKJ p &'J6JK6 p8B

    B9=29/BC8D76E

    F97=>'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2: &'J66KK pJEHS//1+).0%4.-@034 &'J66KJ pBK

    S//1:1+).0%,34P0:%,3@+,:1)> &'J66K6 pBK

    LS7/EHDC?268E/C29/M2&9//+//LH922/E&?C%2E/C29/EHDC?268

    F97=>'8/P6Q79?&8D76;//%V.1G3/%-3:I+/4%4P2I%.4%:I3%%J6K!4,1!'8/P6Q79?&8D76;//6-#%01]P1/%4.-@0345R6&%M82;

    S--+)1.

    Ammonia (NH)

    LH922/EHDC?268E/C29/M2&9//+//NDO2/E&?C%2E/C29/EHDC?268

    F97=>'8/P6Q79?&8D76;//J-#%01]P1/%4.-@034%2+):.1)1)>%303G.:3/%03G304%+*%T101,PT1)%41-10.,%:+%:I+43%*+P)/%1)%)3+).:34%.)/%01G3,%/143.435

    R6&%M82E;

    L101,PT1)\%:+:.0%% %L101,PT1)\%/1,32:L101,PT1)\%+:I3,%*,.2+)4%W01-1:3/%1)4:,P-3):4Y

    Elevated Bilirubin (NB)

    B9=29/BC8D76E

    F97=>'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2:%7%J7E%.).0A:34 &'JJ8KK pJ &'JJ8J6 pCK

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    !#

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    Analytes listed in black are regulated under CLIA 88. ** Not accepted by the CAP Laboratory Accreditation Program, see page 5 for more information.

    LS7/EHDC?268E/C29/M2&9//+//LH922/E&?C%2E/C29/EHDC?268

    F97=>'8/P6Q79?&8D76;//#A+@I101N3/%43,P-%4.-@0345%%S%65K-#%20.44%S%G+0P-3:,12%@1@33%.)/%,3.>3):%>,./3%V.:3,%.,3%,32+--3)/3/%*+,%,32+)4:P+)5%

    R6&%M82E;?7@3@/3vv% % &'$()4P01)vv% % 6'8/P6Q79?&8D76;//6-#%VI+03%T0++/%4.-@0345%%$3-.:+2,1:%@,+G1/3/5%

    R6&%M82;U3/%2300%*+0.:3

    RBC Folate (FR)

    LS7/EHDC?268E/C29/M2&9//+//LH922/E&?C%2E/C29/EHDC?268

    F97=>'8/P6Q79?&8D76;//'8/P6Q79?&8D76;//6-#%01]P1/%4.-@0345

    R6&%M82E;?S%J63)12%3-T,A+)12%.)>3)%W?9SY?S%J3)\%*,33%W*,33%&"SY?S%JH7Hvv% &,+4:.:3%4@321!2%.)>3)\%:+:.0%W&"SY

    Tumor Markers (MT)

    B9=29/BC8D76E

    F97=>'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2: &'J68KK pJ;;

    B9=29/BC8D76E

    F97=>'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2: &'J6'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2: &'J6BKK pJBK

    B9=29/BC8D76E

    F97=>'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2:%7%J7 &'J6;K6 pBE

    L.43%@,+/P2:%7%Bu%.).0A:34 &'J6;JK pJC6

    S//1+).0%4.-@034 &'J6;JJ p;6

    S//1:1+).0%,34P0:%,3@+,:1)> &'J6;J6 pBE

    B9=29/BC8D76E

    F97=>'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2:%7%J78%.).0A:34 &'J6CKK pJBK

    S//1+).0%4.-@034 &'J6CKJ pBK

    S//1:1+).0%,34P0:%,3@+,:1)> &'J6CK6 p &'J6CJ6 p

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    !,

    ,7*01'.

    See page 4 for Product Type information

    Analytes listed in black are regulated under CLIA 88. ** Not accepted by the CAP Laboratory Accreditation Program, see page 5 for more information

    LS7/EHDC?268E/C29/M2&9//+//LH922/E&?C%2E/C29/EHDC?268

    F97=>'8/P6Q79?&8D76;//#1]P1/%4.-@034%1):3)/3/%:+%41-P0.:3%@03P,.0\%@3,1:+)3.0\%.)/%-142300.)3+P4%T+/A%"P1/4%W+:I3,%:I.)%?"O%+,%P,1)3Y5

    R6&%M82E;% %S0TP-1)% % ?,3.)1)3% @$S-A0.43% % M0P2+43% % &,+:31)?I+034:3,+0% % #^% % ',1>0A23,1/34

    Body Fluid Chemistry (PC)

    LS7/EHDC?268E/C29/M2&9//+//LH922/E&?C%2E/C29/EHDC?268

    F97=>'8/P6Q79?&8D76;//#1]P1/%4.-@0345

    R6&%M82E;?I0+,1/3% % #^% % "+/1P-M0P2+43% % &+:.441P-#.22%.21/% % &,+:31)

    Spinal Fluid Chemistry (SF)

    B9=29/BC8D76E

    F97=>'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2: &'J8KKK pJCE

    S//1+).0%4.-@034 &'J8KKJ p;K

    S//1:1+).0%,34P0:%,3@+,:1)> &'J8KK6 pBB

    B9=29/BC8D76E

    F97=>'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2: &'J8JKK p66K

    S//1+).0%4.-@034 &'J8JKJ p;K

    S//1:1+).0%,34P0:%,3@+,:1)> &'J8JK6 pBB

    LS7/EHDC?268E/C29/M2&9//+//LH922/E&?C%2E/C29/EHDC?268

    F97=>'8/P6Q79?&8D76;//#1]P1/%4.-@0345%%'I343%4.-@034%.,3%)+:%2+-@.:1T03%V1:I%:I3%%P!?!:?%.).0AN3,5

    R6&%M82E;SX?%,.+\%]P.):.G3% % F12,+.0TP-1)\%]P.):.G3SX?%,.+\%43-17]P.):.G3% F12,+.0TP-1)\%43-17]P.):.G3S-A0.43% % % =4-+0.01:A?.021P-% % % &I+4@I+,P4?I0+,1/3% % % &+:.441P-?,3.)1)3\%]P.):.G3% &,+:31)?,3.)1)3\%43-17]P.):.G3% "+/1P-M0P2+43% % % R,3.%[1:,+>3)F.>)341P-% % % R,12%.21/

    F12,+.0TP-1)\%]P.01:.

    G3%

    Urine Chemistry (CU)

    LH922/EHDC?268E/C29/M2&9//+//LS7/E&?C%2E/C29/EHDC?268

    F97=>'8/P6Q79?&8D76;// JK-#%4.-@034%1):3)/3/%*+,%:I3%]P.01:.G3%/3:32+)%+*%/,P>4%P41)>%P,1)3%1--P)+.44.A%42,33)1)>%@,+23/P,345

    R6&%M82E;/S23:.-1)+@I3)% % F^FS%W924:.4AYS-@I3:.-1)34% % F3:I./+)3L.,T1:P,.:34% % % F3:I.-@I3:.-1)34L3)N+/1.N3@1)34% % F3:I.]P.0+)3LP@,3)+,@I1)3vv% % F+,@I1)3?.)).T1)+1/4%W'$?Y% % =@1.:34?+2.1)3%F3:.T+01:34% % =bA2+/+)39^^&vv% % % &I3)2A201/1)3%W&?&Y9:I.)+0%WS02+I+0Y% % &,+@+bA@I3)3#"^vv% % % ',12A2012%.)/3@,344.):4

    Urine Drug Screen (UD)

    B9=29/BC8D76E

    F97=>'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2: &'J88KK p6KC

    S//1+).0%4.-@034 &'J88KJ p;E

    S//1:1+).0%,34P0:%,3@+,:1)> &'J88K6 pBK

    B9=29/BC8D76E

    F97=>'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2:%7%J78%.).0A:34 &'J86KK pJ &'J86J6 pC6

    L.43%@,+/P2:%7%JJu%.).0A:34 &'J866K p6;B

    S//1+).0%4.-@034 &'J866J p;K

    S//1:1+).0%,34P0:%,3@+,:1)> &'J8666 pC6

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    !.

    B9=29/BC8D76E

    F97=>'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2: &'J;KKK p8HK

    S//1:1+).0%,34P0:%,3@+,:1)> &'J;KK6 p8B

    B9=29/BC8D76E

    F97=>'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2: &'J;KJK p6KK

    B9=29/BC8D76E

    F97=>'8/LMC2 F97=>'8/

    @7=2

    R66>&%/

    F9D'2L.43%@,+/P2: &'J;JKK pJBK

    S//1+).0%4.-@034 &'J;JKJ p;K

    S//1:1+).0%,34P0:%,3@+,:1)> &'J;JK6 p;K

    B9=29/BC8D76E

    F97=>'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2: &'J;JJK pJBK

    S//1

    +).0%4.-@034 &'J;JJJ p;KS//1:1+).0%,34P0:%,3@+,:1)> &'J;JJ6 p;K

    See page 4 for Product Type information.

    Analytes listed in black are regulated under CLIA 88.

    LS7/EHDC?268E/C29/M2&9//+//LH922/E&?C%2E/C29/EHDC?268

    F97=>'8/ P6Q79?&8D76;/ / J-#%VI+03% T0++/%4.-@0345%% 'I343%4.-@034%.,3%)+:%[email protected]%V1:I%%!?!:?,%#FQQ5

    R6&%M82;$3-+>0+T1)%SJ2

    Glycohemoglobin (GH)

    LS7/EHDC?268E/C29/M2&9//+//LH922/E&?C%2E/C29/EHDC?268

    F97=>'8/P6Q79?&8D76;//K50+T1)%SJ2

    Glycohemoglobin Afinion AS100(GHA)

    LS7/EHDC?268E/C29/M2&9//+//LH922/E&?C%2E/C29/EHDC?268

    F97=>'8/P6Q79?&8D76;//!I+03%T0++/%4.-@0345%():3)/3/%*+,%V.1G3/%-3:I+/45

    R6&%M82;L0++/%03./

    Blood Lead QA (BL)

    LH922/EHDC?268E/C29/M2&9//+//NDO2/E&?C%2E/C29/EHDC?268

    F97=>'8/P6Q79?&8D76;//!I+03%T0++/%4.-@0345%

    R6&%M82;L0++/%03./

    Blood Lead Reg (PB)

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    !-

    ,7*01'.

    See page 4 for Product Type information

    Analytes listed in black are regulated under CLIA 8

    B9=29/BC8D76E

    F97=>'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2: &'J;;KK pJ6E

    LS7/EHDC?268E/C29/M2&9//+//NDO2/E&?C%2E/C29/E28/C29/EHDC?268

    F97=>'8/P6Q79?&8D76;// 6-#%VI+03%T0++/%4.-@034%1):3)/3/%*+,% V.1G3/%>0P2+43%-3:3,45% %".-@034%.,3%2+-@.:1T03%V1:I%-+4:%T0++/%>0P2+43%-3:3,4%P43/%*+,%.)2100.,AX@+1):%+*%2.,3%:34:1)>5%%".-@034%)+:%2+-@.:1T03%V1:I%G7@:&375

    =,/3,%T.43%@,+/P2:%.22+,/1)>%:+%)P-T3,%+*%,34P0:%43:4%,3@+,:3/5%%S//1 +).0%4.-@034%@,+/P2:%1)20P/34%+)0A%+)3%43:%+*%4.-@0345

    U34P0:%"3:4% L.43%@,+/P2:%1)20P/34% J76K% J%43:%+*%4.-@034

    % 6J7;K% 6%43:4%+*%4.-@034

    % ;J7BK% 8%43:4%+*%4.-@034

    % BJ7EK% ;%43:4%+*%4.-@034

    R6&%M82;!I+03%L0++/%M0P2+43%WV.1G3/Y

    Whole Blood Glucose 5 Samples (WB)

    LS7/EHDC?268E/C29/M2&9//+//LH922/E&?C%2E/C29/E28/C29/EHDC?268

    F97=>'8/P6Q79?&8D76;//6-#%VI+03%T0++/%4.-@034%1):3)/3/%*+,%V.1G3/%>0P2+43%-3:3,45%%".-@034%.,3%2+-@.:1T03%V1:I%-+4:%T0++/%>0P2+43%-3:3,4%P43/%*+,%.)2100.,AX@+1):%+*%2.,3%:34:1)>5%%".-@034%)+:%2+-@.:1T03%V1:I%G7@:&375

    =,/3,%T.43%@,+/P2:%.22+,/1)>%:+%)P-T3,%+*%,34P0:%43:4%,3@+,:3/5%%S//1+).0%4.-@034%@,+/P2:%1)20P/34%+)0A%+)3%43:%+*%4.-@0345

    U34P0:%"3:4% L.43%@,+/P2:%1)20P/34% J76K% J%43:%+*%4.-@034

    % 6J7;K% 6%43:4%+*%4.-@034

    % ;J7BK% 8%43:4%+*%4.-@034

    % BJ7EK% ;%43:4%+*%4.-@034

    R6&%M82;!I+03%L0++/%M0P2+43%WV.1G3/Y

    Whole Blood Glucose 3 Samples (SW)

    LS7/EHDC?268E/C29/M2&9//+//LH922/E&?C%2E/C29/EHDC?268F97=>'8/P6Q79?&8D76;//J-#%VI+03%T0++/%4.-@034%.)/%,3@+,)>%*+,%P@%:+%&%/F9D'2

    L.43%@,+/P2:4

    J76K%,34P0:%43:4 &'J;6KK p6KK

    6J7;K%,34P0:%43:4 &'J;6JK p8C;;J7BK%,34P0:%43:4 &'J;66K p'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2:4

    J76K%,34P0:%43:4 &'J;8KK pJ8;

    6J7;K%,34P0:%43:4 &'J;8JK p6;B

    ;J7BK%,34P0:%43:4 &'J;86K p8

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    !A

    B9=29/BC8D76E

    F97=>'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2: &'J&%/F9D'2

    L.43%@,+/P2: &'J&%/

    F9D'2

    L.43%@,+/P2: &'J&%/F9D'2

    L.43%@,+/P2: &'J0+T1)% ',+@+)1)%'

    Cardiac Markers 5 Samples (IE)

    LS7/EHDC?268E/C29/M2&9//+//LH922/E&?C%2E/C29/EHDC?268

    F97=>'8/P6Q79?&8D76;// 6-#%01]P1/%4.-@0345%%?+-@.:1T03%V1:I%!"#$%$5%%?U&%-3:I+/4%P43/%:+%42,33)%*+,%)+)74@321*12%1)*0.--.:+,A%/143.43%4I+P0/%+,/3,%(--P)+43,+0+>A7?U&%+)%@.>3%6%+)0A%/7/1-3,%4I+P0/%+,/3,%^7/1-3,7',1.>3%+)%@.>3%JH5

    R6&%M82E;L[&% % /7/1-3,% % ',+@+)1)%(?o7FL% FA+>0+T1)% %

    Cardiac Assessment Triage (CP)

    LS7/EHDC?268E/C29/M2&9//+//LH922/E&?C%2E/C29/EHDC?268

    F97=>'8/P6Q79?&8D76;// J-#%9^'S%@0.4-.%4.-@034%2+-@.:1T03%V1:I%.P:+-.:3/%-3:I+/4%1)20P/1)>%%JJ:==E,57

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    !)

    (42@41*(-

    B9=29/BC8D76E

    F97=>'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2: &'6KKKK pJ;C

    S//1+).0%4.-@034 &'6KKKJ p &'6KKK6 pBK

    B9=29/BC8D76E

    F97=>'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2:%7%&U? &'6KJKK p68J

    S//1+).0%4.-@034 &'6KJKJ pJ &'6KJK6 p;E

    L.43%@,+/P2:%7%&_" &'6KJJK p6JH

    S//1+).0%4.-@034 &'6KJJJ pHB

    S//1:1+).0%,34P0:%,3@+,:1)> &'6KJJ6 p;E

    B9=29/BC8D76E

    F97=>'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2: &'6K6KK pJ8K

    S//1+).0%4.-@034 &'6K6KJ pBB

    S//1:1+).0%,34P0:%,3@+,:1)> &'6K6K6 p;E

    B9=29/BC8D76E

    F97=>'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2: &'6K6JK pJ6K

    S//1+).0%4.-@034 &'6K6JJ pBB

    S//1:1+).0%,34P0:%,3@+,:1)> &'6K6J6 p;E

    See page 4 for Product Type information

    Analytes listed in black are regulated under CLIA 8

    INR (Waived Method) CoaguChek XS (CXSW)

    LH922/EHDC?268E/C29/M2&9//+//NDO2/E&?C%2E/C29/EHDC?268

    F97=>'8/P6Q79?&8D76;//#A+@I101N3/%@0.4-.%4.-@0345%%S%J5K-#%20.44%S%G+0P-3:,12%@1@3::3%.)/%,3.>3):%>,./3%V.:3,%.,3%,32+--3)/3/%*+,%,32+)4:1:P:1+)5%%'I343%4.-@034%.,3%[='%2+-@.:1T03%V1:I%VI+03%T0++/%1)4:,P-3):4%X%4A4:3-4%4P2I%.4%17#$%$E,/$&E,&:6A3&L7OE,+,,&:6A3#7?475

    R6&%M82E;S2:1G.:3/%@.,:1.0%:I,[email protected]:1)%:1-3%WS&''Y

    O1T,1)+>3)&,+:1-3%W&'Y([U

    Coagulation Basic (CA)

    LH922/EHDC?268E/C29/M2&9//+//NDO2/E&?C%2E/C29/EHDC?268

    F97=>'8/P6Q79?&8D76;//():3)/3/%*+,%)+)7V.1G3/%4A4:3-45%%".-@034%1)%3.2I%T.43%@,+/P2:%.)/%.//1:1+).0%4.-@034%@,+/P2:%.,3%1)4:,P-3):%4@321*125

    % ".-@034% [email protected]%V1:I

    % &U?% %!"#$%$,6?;,&:6A3#7?47,1)4:,P-3):4

    % &_"% &:6A3&L7O,N#,"A4:3-4%W&0P4\%&,+\%_"Y

    R6&%M82E;

    &,+:1-3([U

    Protime / INR (Whole Blood)

    LS7/EHDC?268E/C29/M2&9//+//LH922/E&?C%2E/C29/EHDC?268

    F97=>'8/P6Q79?&8D76;// ".-@034%1):3)/3/%*+,%/$&,19:$!@7,)!

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    !K

    B9=29/BC8D76E

    F97=>'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2: &'6K;KK pJ6;

    S//1+).0%4.-@034 &'6K;KJ p &'6K;K6 p;E

    B9=29/BC8D76E

    F97=>'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2: &'6K;JK pJ8K

    B9=29/BC8D76E

    F97=>'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2: &'6K;6K pJ8B

    S//1+).0%4.-@034 &'6K;6J pEB

    S//1:1+).0%,34P0:%,3@+,:1)> &'6K;66 p;E

    See page 4 for Product Type information.

    Analytes listed in black are regulated under CLIA 88.

    LS7/EHDC?268E/C29/M2&9//+//LH922/E&?C%2E/C29/EHDC?268

    F97=>'8/P6Q79?&8D76;/// L.43%@,+/P2:%.)/%.//1:1+).0%4.-@03%@,+/P2:%Q1:%3.2I%@,+G1/3%:I,33%0A+@I101N3/%4.-@034%V1:I%/10P3):%.)/%.%2.021P-%2I0+,1/3%4+0P:1+)%W.2:1G.:+,Y5%%S//1:1+).0%4.-@034%W+)0AY%1)20P/34%4.-@034%V1:I%/10P3):%.)/%)+%?.?05%%&,+/P2:4%.,3%1)4:,P-3):%4@321*125

    % ".-@034% [email protected]%V1:I% ?'L% /$&,G*)(&G+(0,4C4=7@4E,/-,.*),1&-E,G727?6,%'8/P6Q79?&8D76;//#A+@I101N3/%@0.4-.%4.-@034%2+-@.:1T03%V1:I%-+4:%/7/1-3,%Q1:4%1)20P/1)>% #C4@7K,&%,.)/%#!@82!PC%VI3,3%@.:13):%@0.4-.%14%:34:3/5%%[+:%

    1):3)/3/%*+,%!"#$%$E,#!@82!+7;E,+,,#!@82!PC,STL:27,J2::;U5R6&%M82;

    /7/1-3,\%]P.01:.:1G3% % /7/1-3,\%]P.):1:.:1G3

    D-dimer Plasma (DD)

    LS7/EHDC?268E/C29/M2&9//+//LH922/E&?C%2E/C29/EHDC?268

    F97=>'8/P6Q79?&8D76;//#A+@I101N3/%@0.4-.%4.-@034%.)/%.%G1.0%+*%V.4I3/%UL?%/10P3):5%?+-@.:1T03%V1:I%#!@82!+7;R%%S04+%2+-@.:1T03%V1:I%#!@82!PC%VI3)%@.:13):%VI+03%T0++/%14%:34:3/5

    R6&%M82;/7/1-3,\%]P.01:.:1G3

    D-dimer Whole Blood (DR)

    LS7/EHDC?268E/C29/M2&9//+//LH922/E&?C%2E/C29/EHDC?268

    F97=>'8/P6Q79?&8D76;//".-@034%2I.003)>3%.%/1**3,3):%,34P0:%,.)>3%:I.)%^^\%^U%.)/%?&%@,+/P2:45%%(*%P41)>%.%$9!6A7%:34:%/3G123X2.,:,1/>3%:I.:%,3@+,:4%-+,3%:I.)%/7/1-3,\%+,/3,%?.,/1.2%S44344-3):7 $9!6A7%+)%@.>3%JC5

    R6&%M82;/7/1-3,\%]P.):1:.:1G3

    D-dimer Triage (DT)

    B9=29/BC8D76E

    F97=>'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2:%7%?'L &'6K8KK p6JE

    S//1+).0%4.-@03%Q1: &'6K8KJ pB6

    S//1+).0%4.-@034%W+)0AY &'6K8EJ p &'6K8K6 p;K

    L.43%@,+/P2:%7%?'= &'6K8JK p6JE

    S//1+).0%4.-@03%Q1: &'6K8JJ pB6

    S//1+).0%4.-@034%W+)0AY &'6K8HJ p &'6K8J6 p;K

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    "*

    ,741((2.

    B9=29/BC8D76E

    F97=>'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2: &'6JKKK p6KC

    S//1:1+).0%,34P0:%,3@+,:1)> &'6JKK6 pBB

    See page 4 for Product Type information

    Analytes listed in black are regulated under CLIA 88

    B9=29/BC8D76E

    F97=>'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2:%7%S' &'6JJKK p68C

    S//1:1+).0%,34P0:%,3@+,:1)> &'6JJK6 pBB

    L.43%@,+/P2:%7%S" &'6JJJK p68CS//1:1+).0%,34P0:%,3@+,:1)> &'6JJJ6 pBB

    LH922/EHDC?268E/C29/M2&9//+//NDO2/E&?C%2E/C29/EHDC?268

    F97=>'8/P6Q79?&8D76;// !I+03%T0++/%4.-@034%V1:I%@13,23.T03%2.@4%*+,%-.)P.0%+,%.P:+-.:3/%-3:I+/45%%

    ?+-@.:1T03%V1:I%

    %JJ:==,&722"MC?,FVQQE,FWQQE,FXQQE,FHQQE,*@7962;Y,%5N,)!

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    "!

    B9=29/BC8D76E

    F97=>'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2: &'6J;KK pJ66

    S//1+).0%4.-@034 &'6J;KJ p &'6J;K6 p;K

    B9=29/BC8D76E

    F97=>'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2: &'66KKK p6KK

    S//1+).0%4.-@034 &'66KKJ p;E

    S//1:1+).0%,34P0:%,3@+,:1)> &'66KK6 p;K

    B9=29/BC8D76E

    F97=>'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2: &'666KK pJ'8/P6Q79?&8D76;// #1]P1/%VI+03%T0++/%4.-@034%2+-@.:1T03%V1:I%G7@:&37,G7@:A2:J!?,#C4=7@4E,/$&,GAJ,19:E,#$%$"#!=7,)E,#83?,L7@6=:'8/P6Q79?&8D76;//":.T101N3/%UL?%4.-@0345

    R6&%M82;"12Q03%2300%42,33)

    Sickle Cell Screen (SK)

    B9=29/BC8D76E

    F97=>'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2:%7%"U &'66JKK pJ &'66JK6 p;K

    L.43%&,+/P2:%7%"US &'66JJK pJ &'66JJ6 p;K

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    ""

    =+'(0+(;.

    B9=29/BC8D76E

    F97=>'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2: &'8KKKK p66;

    S//1+).0%4.-@034 &'8KKKJ pJ;K

    S//1:1+).0%,34P0:%,3@+,:1)> &'8KKK6 p;K

    B9=29/BC8D76E

    F97=>'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2:4

    SP:+-.:3/%2+P):%WLOSY &'8KJKK pJHK

    F.)P.0%2300%2+P):%WLOFY &'8KJJK pJEK

    B9=29/BC8D76E

    F97=>'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2: &'8K6KK p;6

    B9=29/BC8D76E

    F97=>'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2: &'8K8KK pJJE

    S//1+).0%4.-@034 &'8K8KJ p8K

    S//1:1+).0%,34P0:%,3@+,:1)> &'8K8K6 p8K

    B9=29/BC8D76E

    F97=>'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2: &'8K;KK pJ6E

    B9=29/BC8D76E

    F97=>'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2: &'8K%4@1).0%.)/X+,%4A)+G1.0%*0P1/%.).0A4145

    R6&%M82E;?300%1/3):1*12.:1+)% ?,A4:.0%1/3):1*12.:1+)

    Body Fluid Microscopy (BF)

    LS7/EHDC?268E/C29/M2&9//+//LH922/'H&%%26U2E/C29/EHDC?268

    F97=>'8/P6Q79?&8D76;// K5.4:,12%+22P0:%T0++/%.)/%.-)1+:12XT+/A%*0P1/%@$%-3.4P,3-3):5%%

    @$%14%2+-@.:1T03%V1:I%[1:,.N1)3%.)/%01:-P4%@.@3,%:34:1)>5

    R6&%M82E;@$% % % =22P0:%T0++/

    Body Fluid pH/Occult Blood (GO)

    LS7/EHDC?268E/C29/M2&9//+//LH922/E&?C%2E/C29/EHDC?268

    F97=>'8/P6Q79?&8D76;//?03.,\%@,+:31)7T.43/%4.-@034%1):3)/3/%*+,%0.T4%@3,*+,-1)>%4@1).0%.)/X+,%4A)+G1.0%*0P1/%2300%2+P):4%TA%.P:+-.:3/%+,%-.)P.0%-3:I+/45

    R6&%M82E;U3/%T0++/%2300%2+P):% !I1:3%T0++/%2300%2+P):

    Body Fluid Cell Count

    LS7/EHDC?268E/C29/M2&9//+//LH922/E&?C%2E/C29/EHDC?268

    F97=>'8/P6Q79?&8D76;//'8/P6Q79?&8D76;//".-@034%*+,%/3:32:1)>%:I3%@,343)23X.T43)23%+*%*0P1/%*,+-%,P@:P,3/%*3:.0%-3-T,.)345%%():3)/3/%*+,%P43%V1:I%:I3%%@?!4397,+()%Q1:%+)0A5

    R6&%M82;&SFM7J%@,+:31)

    Amniotic Fluid Detection Amnisure ROM(AE)

    LS7/EHDC?268E/C29/M2&9//+//LH922/E&?C%2E/C29/EHDC?268

    F97=>'8/P6Q79?&8D76;//?+-@.:1T03%V1:I%:I3,-*'^("$*#$E,-*'^(,*_,D'*E,/5M,&L7OE,.)/,/5M,*_,D'*,-3:I+/45

    F97'2=>92;#.2:+*3,,1)

    Fecal Lactoferrin (LF)

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    "#

    B9=29/BC8D76E

    F97=>'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2: &'8KBKK p8KK

    B9=29/BC8D76E

    F97=>'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2: &'8KCKK pJ'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2: &'8JJKK pJ8E

    S//1+).0%4.-@034 &'8JJKJ p;K

    S//1:1+).0%,34P0:%,3@+,:1)> &'8JJK6 p;K

    B9=29/BC8D76E

    F97=>'8/LMC2 F97=>'8/

    @7=2

    R66>&%/

    F9D'2L.43%@,+/P2: &'8J6KK p;6

    S//1+).0%4.-@034 &'8J6KJ pJK

    S//1:1+).0%,34P0:%,3@+,:1)> &'8J6K6 p6;

    See page 4 for Product Type information.

    Analytes listed in black are regulated under CLIA 88.

    LS7/EHDC?268E/C29/M2&9//+//LS7/'H&%%26U2E/C29/C97'2=>92

    F97=>'8/P6Q79?&8D76;//'V+%@I+:+%2+-@+41:34%+*%3.2I%+*%:I3%@,+23/P,34%014:3/%T30+V5%%U3@+,:%+)0A%:I+43%@,+23/P,34%@3,*+,-3/5%%&'&0P4%+)01)3%&&F%?+-@3:3)2A%.04+%.G.10.T03%+)%@.>3%B5

    F97'2=>92E;O32.0%4-3.,%*+,%03PQ+2A:34% &1)V+,-%@,3@.,.:1+)O3,)%:34:% % % R,1)3%43/1-3):o=$%@,3@.,.:1+)% % D.>1).0%V3:%@,3@.,.:1+)[.4.0%4-3.,%*+,%3+41)+@I104

    Provider Performed Microscopy (PM)

    LS7/EHDC?268E/C29/M2&9//+//LH922/E&?C%2E/C29/EHDC?268

    F97=>'8/P6Q79?&8D76;//J-#%01]P1/%41-P0.:3/%23,G12+7G.>1).0%4.-@0345

    R6&%M82E;O3:.0%*1T,+)32:1)

    Fetal Fibronectin (FFN)

    LS7/EHDC?268E/C29/M2&9//+//NDO2/E&?C%2E/C29/EHDC?268F97=>'8/P6Q79?&8D76;//#1]P1/%4.-@034%*+,%P,1)3%@,3>).)2A5

    R6&%M82;R,1)3%I?M%r%]P.01:.:1G3%WV.1G3/Y

    Urine hCG 5 Samples (UH)

    LS7/EHDC?268E/C29/M2&9//+//LS7/'H&%%26U2E/C29/EHDC?268

    F97=>'8/P6Q79?&8D76;//S%@I+:+%2+-@+41:3%+*%:V+%P,1)3%43/1-3):%2+-@+)3):45

    F97'2=>92;R,1)3%43/1-3):%2+-@+)3):%1/3):1*12.:1+)%TA%-12,+42+@3

    Urine Sediment Identification (SU)

    B9=29/BC8D76E

    F97=>'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2: &'8JKKK pJK;

    S//1+).0%4.-@034 &'8JKKJ p8B

    S//1:1+).0%,34P0:%,3@+,:1)> &'8JKK6 p'8/P6Q79?&8D76;// #1]P1/%4.-@034%*+,%P,1).0A414%.)/% P,1)3% @,3>).)2A5%?,3.:1)1)3%14%*+,%/1@4:12Q%-3:I+/%+)0A%W,3*3,%:+%R,1)3%?I3-14:,A%+)%@.>3%J;%*+,%+:I3,%-3:I+/4Y5%%"3,P-%I?M%433%@.>3%JJ5

    R6&%M82E;% %L101,PT1)% % % o3:+)34% % % &,+:31)?,3.:1)1)3\%43-17]P.):1:.:1G3% #3PQ+2A:3%34:3,.43% "@321*12%>,.G1:AM0P2+43% % % [1:,1:3% % % R,+T101)+>3)$3-+>0+T1)XL0++/% % @$

    ?+)*1,-.:+,A%'34:1)>% % R,1)3%I?MS23:34:% % % R,1)3%I?M%r%]P.01:.:1G3%WV.1G3/Y(2:+:34:U3/P21)>%4PT4:.)234

    Urinalysis / Urine hCG (UR)

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    ",

    ,7,-

    -4.*0

    B9=29/BC8D76E

    F97=>'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2: &'86KKK p6;K

    S//1+).0%4.-@034 &'86KKJ pJ8K

    S//1:1+).0%,34P0:%,3@+,:1)> &'86KK6 p8K

    B9=29/BC8D76E

    F97=>'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2: &'86JKK p6;K

    B9=29/BC8D76E

    F97=>'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2:4

    R)4:.1)3/%401/3%W"FY &'866KK p6;K

    &,374:.1)3/%401/3%W"F"Y &'866JK p6;K

    B9=29/BC8D76E

    F97=>'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2: &'868KK p6BK

    B9=29/BC8D76E

    F97=>'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2: &'86;KK p6;K

    See page 4 for Product Type information

    Analytes listed in black are regulated under CLIA 8

    LS7/EHDC?268E/C29/M2&9//+//LS7/E&?C%2E/C29/EHDC?268

    F97=>'8/P6Q79?&8D76;//K56-#%4:.T101N3/%IP-.)%4@3,-%4.-@034%.@@,+@,1.:3%*+,%@+4:7G.432:+-A%42,33)1)>5

    F97'2=>92;"@3,-%2+P):\%]P.01:.:1G3

    Post-Vasectomy Semen Analysis (PV)

    LS7/EHDC?268E/C29/M2&9//+//LS7/E&?C%2E/C29/EHDC?268

    F97=>'8/P6Q79?&8D76;//K56-#%4:.T101N3/%01]P1/%4.-@0345

    F97'2=>92;"@3,-%2+P):\%]P.):1:.:1G3

    Sperm Count (SP)

    LS7/EHDC?268E/C29/M2&9//+//B62/E%D=2/&6=/CH787U9&CH/C29/EHDC?268

    F97=>'8/P6Q79?&8D76;//=,/3,%T.43%@,+/P2:%TA%401/35%%&,374:.1)3/%401/3%14%1):3)/3/%*+,%G3@6A7?`,$74=4!@827=4

    F97'2=>92;"@3,-%-+,@I+0+>A

    Sperm Morphology

    LS7/EHDC?268E/C29/M2&9//+//B62/@1+T7?/C29/EHDC?268

    F97=>'8/P6Q79?&8D76;// S%?^7U+-%V1:I%G1/3+4%+*%:V+%43-3)%4.-@0345%%D1/3+4%2+):.1)%-P0:1@03%-12,+42+@12%*130/4%4I+V1)>%01G3%.)/%1--+T101N3/%4@3,-5

    F1)1-P-%,3]P1,3-3):4Z%%wS/+T3%F3/1.%&0.A3,%Hm%w!1)/+V4%_&m%wS:%03.4:%6'8/P6Q79?&8D76;//9+41)7[1>,+41)74:.1)3/%401/345

    F97'2=>92;"@3,-%G1.T101:A

    Sperm Viability (SV)

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    ".

    B9=29/BC8D76E

    F97=>'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2: &';KKKK p8H8

    S//1+).0%4.-@034 &';KKKJ pJ;J

    S//1:1+).0%,34P0:%,3@+,:1)> &';KKK6 pBB

    B9=29/BC8D76E

    F97=>'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2: &';KJKK p66&%/F9D'2

    L.43%@,+/P2: &';JKKK pJ8E

    B9=29/BC8D76E

    F97=>'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2: &';JJKK pJ8E

    B9=29/BC8D76E

    F97=>'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2: &';J6KK pE;

    S//1+).0%4.-@034 &';J6KJ p6K

    S//1:1+).0%,34P0:%,3@+,:1)> &';J6K6 p;E

    B9=29/BC8D76E

    F97=>'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2: &';J8KK pJ8;

    See page 4 for Product Type information.

    Analytes listed in black are regulated under CLIA 88.

    LH922/EHDC?268E/C29/M2&9//+//NDO2/'H&%%26U2E/C29/EHDC?268

    F97=>'8/P6Q79?&8D76;//O1G3%01]P1/%W8-#YX%,3/%2300%W6-#Y%4.-@03%@.1,4%V1:I%+)3%;-#%/+)+,%4.-@03%*+,%2+-@.:1T101:A%:34:1)>5

    R6&%M82E;SL=%>,+P@1)>%% % %%% ?+-@.:1T101:A%:34:1)>UI%W^Y%:A@1)>% % % %%% S):1T+/A%1/3):1*12.:1+)R)3b@32:3/%.):1T+/A%/3:32:1+)%%%% ^S'

    Blood Bank (Immunohematology) Comprehensive (AB)

    LH922/EHDC?268E/C29/M2&9//+//NDO2/'H&%%26U2E/C29/EHDC?268

    F97=>'8/P6Q79?&8D76;//O1G3%01]P1/%W8-#YX%,3/%2300%W6-#Y%4.-@03%@.1,45

    R6&%M82E;SL=%>,+P@1)>UI%W^Y%:A@1)>^S'

    Blood Bank (Immunohematology) Limited (AR)

    LH922/EHDC?268E/C29/M2&9//+//NDO2/E&?C%2E/C29/EHDC?268

    F97=>'8/P6Q79?&8D76;//K5C-#%43,P-%4.-@0345

    R6&%M82;S):1)P203.,%.):1T+/A\%]P.01:.:1G3

    ANA Immunoserology (XN)

    LH922/EHDC?268E/C29/M2&9//+//NDO2/E&?C%2E/C29/EHDC?268

    F97=>'8/P6Q79?&8D76;//J-#%43,P-%4.-@0345R6&%M82E;

    S):14:,3@:+0A41)%=%WS"=Y\%]P.01:.:1G3S):14:,3@:+0A41)%=%WS"=Y\%]P.):1:.:1G3

    ASO Immunoserology (XS)

    LS7/EHDC?268E/C29/M2&9//+//LH922/E&?C%2E/C29/EHDC?268

    F97=>'8/P6Q79?&8D76;// J-#%43,P-%4.-@0345%%O+,%I1>I%43)41:1G1:A%?U&%-3:I+/4\%+,/3,%?.,/1.2%F.,Q3,4%+)%@.>3%JC5

    R6&%M82E;?7,3.2:1G3%@,+:31)\%]P.01:.:1G3?7,3.2:1G3%@,+:31)\%]P.):1:.:1G3

    CRP Immunoserology (XP)

    LS7/EHDC?268E/C29/M2&9//+//LH922/E&?C%2E/C29/EHDC?268

    F97=>'8/P6Q79?&8D76;//K5

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    "-

    77@-((2.

    B9=29/BC8D76E

    F97=>'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2: &';J&%/F9D'2

    L.43%@,+/P2: &';JBKK pJBE

    B9=29/BC8D76E

    F97=>'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2: &';JCKK pJH6

    B9=29/BC8D76E

    F97=>'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2: &';JEKK pJEB

    See page 4 for Product Type information

    Analytes listed in black are regulated under CLIA 88. ** Not accepted by the CAP Laboratory Accreditation Program, see page 5 for more information

    LH922/EHDC?268E/C29/M2&9//+//NDO2/E&?C%2E/C29/EHDC?268

    F97=>'8/P6Q79?&8D76;//#1]P1/%4.-@0345

    S//7+)%@,+/P2:%1)20P/34%+)3%43:%+*%4.-@034%.)/%,3@+,:1)>%*+,%+)3%43:%+*%,34P0:4%.)/%2.)%+)0A%T3%+,/3,3/%1)%2+)dP)2+)%V1:I%:I3%% % % S):17$SD%W:+:.0%.):1T+/AYvv% %S):17$L2%W:+:.0%.):1T+/AY%% (>F%S):17$SD(>F%S):17$L2% % % S):17$?DS):17$L4%

    Hepatitis (YB)

    LH922/EHDC?268E/C29/M2&9//+//NDO2/E&?C%2E/C29/EHDC?268

    F97=>'8/P6Q79?&8D76;// #1]P1/%4.-@0345%%?+-@.:1T03%V1:I%,.@1/%.)/%:,./1:1+).0%:34:1)>%-3:I+/4%P43/%:+%:34:%*+,%S):17$(D%J%+,% S):17$(D%JX65%% ?+)*1,-.:+,A%,34P0:4%*,+-%S):17$(D%J%!34:3,)%L0+:%-3:I+/4%.,3%,3@+,:.T035

    R6&%M82;S):17$(D

    Anti-HIV (HV)

    LS7/EHDC?268E/C29/M2&9//+//LH922/E&?C%2E/C29/EHDC?268

    F97=>'8/ P6Q79?&8D76;// #1]P1/%4.-@034%1):3)/3/%*+,%V.1G3/%,.@1/%:34:%Q1:45%?+-@.:1T03%V1:I%,.@1/%Q1:4%P43/%:+%:34:%*+,%S):17$(DJ%+,%S):17$(D%JX65

    R6&%M82;S):17$(D

    Anti-HIV (Waived Methods) (HVW)

    LH922/EHDC?268E/C29/M2&9//+//NDO2/E&?C%2E/C29/EHDC?268

    F97=>'8/P6Q79?&8D76;//J-#%43,P-%4.-@0345

    R6&%M82E;%?+-@03-3):%W?8Y% (>S% % (>M?+-@03-3):%W?;Y% (>9\%:+:.0vv% (>F

    Immunoproteins (IP)

    B9=29/BC8D76E

    F97=>'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2: &';J;KK p8KK

    S//1+).0%4.-@034 &';J;KJ pJ6K

    S//7+)%@,+/P2:%W:+%$DY

    &';J;K8 pJK6

    LS7/EHDC?268E/C29/M2&9//+//LH922/E&?C%2E/C29/EHDC?268

    F97=>'8/P6Q79?&8D76;//K5/+,*3,1\%(>MX(>F

    Lyme Disease Serology (LY)

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    "A

    B9=29/BC8D76E

    F97=>'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2: &';6KKK pJ;J

    B9=29/BC8D76E

    F97=>'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2: &';66KK pJ;J

    B9=29/BC8D76E

    F97=>'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2: &';68KK pJ;J

    B9=29/BC8D76E

    F97=>'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2: &';6;KK pJB&%/F9D'2

    L.43%@,+/P2: &';6JKK pEK

    S//1+).0%4.-@034 &';6JKJ p8B

    S//1:1+).0%,34P0:%,3@+,:1)> &';6JK6 p8K

    See page 4 for Product Type information.

    Analytes listed in black are regulated under CLIA 88.

    LH922/EHDC?268E/C29/M2&9//+//NDO2/E&?C%2E/C29/EHDC?268

    F97=>'8/P6Q79?&8D76;//#1]P1/%4.-@034%1):3)/3/%*+,%:I3%]P.):1:.:1G3%.)/%]P.01:.:1G3%3G.0P.:1+)%+*%.):1T+/A%:+%',3@+)3-.%@.001/P-5%%():3)/3/%*+,%-3:I+/4%:I.:%3G.0P.:3%43,P-%4@321-3)4\%35>5\%U&U\%D^U#\%O'S\%F$S7'&\%'&&S\%'UR"'\%.)/%9#("S%Q1:45

    R6&%M82E;"A@I1014%[+):,3@+)3-.0\%]P.01:.:1G3"A@I1014%',3@+)3-.0\%]P.01:.:1G3"A@I1014%[+):,3@+)3-.0\%]P.):1:.:1G3

    Syphilis Serology (SS)

    LH922/EHDC?268E/C29/M2&9//+//NDO2/E&?C%2E/C29/EHDC?268

    F97=>'8/P6Q79?&8D76;//K5C-#%43,P-%4.-@0345

    R6&%M82;()*32:1+P4%-+)+)P203+414

    Mono Immunoserology (ZM)

    LS7/EHDC?268E/C29/M2&9//+//LH922/E&?C%2E/C29/EHDC?268

    F97=>'8/P6Q79?&8D76;//K5C-#%43,P-%4.-@0345

    R6&%M82;()*32:1+P4%-+)+)P203+414

    Mono Immunoserology (Waived Methods) (MW)

    LH922/EHDC?268E/C29/M2&9//+//NDO2/E&?C%2E/C29/EHDC?268

    F97=>'8/P6Q79?&8D76;//J-#%43,P-%4.-@0345R6&%M82E;

    UI3P-.:+1/%*.2:+,\%]P.01:.:1G3UI3P-.:+1/%*.2:+,\%]P.):1:.:1G3

    Rheumatoid Factor Immunoserology (ZR)

    LH922/EHDC?268E/C29/M2&9//+//NDO2/E&?C%2E/C29/EHDC?268

    F97=>'8/P6Q79?&8D76;//J-#%43,P-%4.-@0345

    R6&%M82E;UPT300.\%]P.01:.:1G3% % UPT300.\%]P.):1:.:1G3(>F%UPT300.\%]P.01:.:1G3

    Rubella Immunoserology (XU)

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    B9=29/BC8D76E

    F97=>'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2: &'&%/F9D'2

    L.43%@,+/P2: &'&%/F9D'2

    L.43%@,+/P2: &'&%/F9D'2

    L.43%@,+/P2: &'&%/F9D'2

    L.43%@,+/P2: &''8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2: &''8/P6Q79?&8D76;//F3:I.)+0%*1b3/%401/34%*+,%>,.-%4:.1)1)>5

    F97'2=>92E;M,.-%,3.2:1+)% =,>.)14-%-+,@I+0+>A

    Gram Stain (GS)

    LH922/EHDC?268E/C29/M2&9//+//NDO2/E&?C%2E/C29/EHDC?268

    F97=>'8/P6Q79?&8D76;//S):1>3)%/3:32:1+)%1):3)/3/%*+,%)+)7V.1G3/%-3:I+/4%+)0A5

    F97'2=>92E;/%W)P-T3,%@3,%4I1@-3):Y":,3@%S%.):1>3)%/3:32:1+)%W8Y% ":,3@%S%2P0:P,3%W6Y

    Strep Group A Antigen / Culture (SC)

    LH922/EHDC?268E/C29/M2&9//+//NDO2/E&?C%2E/C29/EHDC?268

    F97=>'8/P6Q79?&8D76;//S):1>3)%/3:32:1+)%1):3)/3/%*+,%)+)7V.1G3/%-3:I+/4%+)0A5F97'2=>92;

    ":,3@%S%.):1>3)%/3:32:1+)

    Strep Group A Antigen (SA)

    LS7/EHDC?268E/C29/M2&9//+//LH922/E&?C%2E/C29/EHDC?268

    F97=>'8/P6Q79?&8D76;//():3)/3/%*+,%V.1G3/%-3:I+/4%+)0A5

    F97'2=>92;":,3@%S%.):1>3)%/3:32:1+)

    Strep Group A Antigen (Waived Methods) (WS)

    LH922/EHDC?268E/C29/M2&9//+//NDO2/E&?C%2E/C29/EHDC?268

    F97=>'8/P6Q79?&8D76;//".-@034%*+,%":,3@%S%2P0:P,35

    F97'2=>92;":,3@%S%2P0:P,3

    Strep Group A Culture (ST)

    LH922/EHDC?268E/C29/M2&9//+//NDO2/E&?C%2E/C29/EHDC?268

    F97=>'8/P6Q79?&8D76;//".-@034%*+,%":,3@%L%/3:32:1+)5

    P=26!'&76/F97'2=>92E/Q79;":,3@%M,+P@%L

    Strep Group B (SB)

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    #*

    D4+1,'*((2.

    B9=29/BC8D76E

    F97=>'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2: &''8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2: &''8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2: &''8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2: &''8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2: &''8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2: &''8/P6Q79?&8D76;//():3)/3/%*+,%-+032P0.,%-3:I+/45

    F97'2=>92E;?I0.-A/1.%:,.2I+-.:14%/3:32:1+)[31443,1.%>+)+,,I+3.3%/3:32:1+)

    CT/GC Detection (AC)

    LH922/EHDC?268E/C29/M2&9//+//NDO2/E&?C%2E/C29/EHDC?268

    F97=>'8/P6Q79?&8D76;//():3)/3/%*+,%.):1>3)%/3:32:1+)%TA%9(S5

    F97'2=>92E;?I0.-A/1.%:,.2I+-.:14%.):1>3)%/3:32:1+)

    Chlamydia Antigen (CE)

    LH922/EHDC?268E/C29/M2&9//+//NDO2/E&?C%2E/C29/EHDC?268

    F97=>'8/P6Q79?&8D76;//".-@034%*+,%M?%2P0:P,35

    P=26!'&76/F97'2=>92E/Q79;

    [31443,1.%>+)+,,I+3.3

    Neisseria gonorrhoeae (GC)

    LH922/EHDC?268E/C29/M2&9//+//NDO2/E&?C%2E/C29/EHDC?268

    F97=>'8/P6Q79?&8D76;//?+-@.:1T03%V1:I%L^%M3)3=I-%.)/%?3@I31/%M3)3_@3,:5

    F97'2=>92E;?5%/1**12103%:+b1)%.)/X+,%.):1>3)%/3:32:1+)

    Clostridium difficile (CD)

    LS7/EHDC?268E/C29/M2&9//+//LH922/E&?C%2E/C29/EHDC?268F97=>'8/P6Q79?&8D76;//".-@034%*+,%"I1>.%'+b1)%J%.)/X+,%6%.)/%P)/1**3,3):1.:3/%

    /3:32:1+)%-3:I+/45

    F97'2=>92E;"I1>.%:+b1)%J%/3:32:1+)%%"I1>.%:+b1)%6%/3:32:1+)"I1>.%:+b1)%P)/1**3,3):1.:3/

    Shiga Toxin (SHG)

    LH922/EHDC?268E/C29/M2&9//+//NDO2/E&?C%2E/C29/EHDC?268/

    F97=>'8/P6Q79?&8D76;// &,+23/P,34%014:3/%T30+V%.,3%*+,%.):1>3)%/3:32:1+)5%?+-@.:1T03%V1:I,5!?6K,0(a,#R,8?73@:R

    F97'2=>92E/W.)

    >3)%/3:32

    +)%+*Y;M,+P@%L%":,3@$.3-+@I10P4%1)*0P3)N.3%:A@3%T[31443,1.%-3)1)>1:1/14%>,+P@%S\%?\%g\%!J81:1/14%>,+P@%L%+,%95%2+01%oJ":,3@:+2+22P4%@)3P-+)1.3

    Bacterial Antigens (for meningitis) (BA)

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    #!

    B9=29/BC8D76E

    F97=>'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2: &'&%/F9D'2

    L.43%@,+/P2: &'&%/F9D'2

    L.43%@,+/P2: &''8/P6Q79?&8D76;// 9.2I% +,>.)14-% 14%@,343):3/% .:%03.4:%+)23%@3,% A3.,5%?+-@.:1T03%V1:I%&,3-13,%?.-@A%9(S5

    P=26!'&76/F97'2=>92E/Q79;S3,+-+).4% % &0341+-+).4% D1T,1+?.-@A0+T.2:3,% ".0-+)300.% g3,41)1.% %95%2+01%=J'8/P6Q79?&8D76;//'I14%14%.)%3/P2.:1+).0%3b3,2143%1):3)/3/%:+%/+2P-3):%`SX2+-@3:3)2A%*+,%T1+0+>12.0%3-3,>3)2A%,34@+)43%41:P.:1+)45%%(:%@,+G1/34%4P,,+>.:3%+,>.)14-4%V1:I%2I.,.2:3,14:124%:I.:%-1-12%@+:3):1.00A%03:I.0%@.:I+>3)45%%"2+,34%.,3%)+:%:,.)4-1::3/%:+%.22,3/1:.:1+)%.>3)21345%%#.T4%P41)>%.)+:I3,%&'%@,+G1/3,%*+,%,3>P0.:+,A%-12,+T1+0+>A%2.)%+,/3,%:I14%43,G1235

    ":.:3%2++,/1).:+,4%2.)%.,,.)>3%:+%3),+00%.)/%*P)/%:I31,%,34@+)43%)3:V+,Q%

    0.T+,.:+,1345%%'I3A%V100%,3231G3%2+@134%+*%.00%,3@+,:4%*+,%P43%1)%.44344-3):%.)/%/+2P-3):.:1+)%+*%[email protected]:A\%,3./1)344\%.)/%:,.1)1)>%)33/45%%&03.43%2.00%EKK7;B67&%/F9D'2

    L.43%@,+/P2:4

    ()/1G1/P.0%0.T4 &'B66KK p6JK

    ":.:3%2++,/1).:+,4 &'K6K6K p6JK

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    #"

    =.+(

    4+1,'

    (2.

    See page 4 for Product Type information

    Analytes listed in black are regulated under CLIA 8

    B9=29/BC8D76E

    F97=>'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2: &'B6KJK p6CK

    B9=29/BC8D76EF97=>'8/LMC2 F97=>'8/

    @7=2R66>&%/

    F9D'2

    L.43%@,+/P2: &'B6K6K p66K

    LS7/EHDC?268E/C29/M2&9//+//NDO2/E&?C%2E/C29/EHDC?268

    F97=>'8/P6Q79?&8D76;//():3)/3/%*+,%,3@+,:1)>%:I3%e@,343)23%+,%.T43)23f%+*%.21/7*.4:%T.210015

    S//7+)%@,+/P2:%1)20P/34%+)3%43:%+*%4.-@034%.)/%,3@+,:1)>%*+,%+)3%43:%+*%,34P0:4%.)/%2.)%+)0A%T3%+,/3,3/%1)%2+)dP)2+)%V1:I%FA2+T.2:3,1+0+>A%?P0:P,3%WFLY%T.43%@,+/P2:5

    F97'2=>92;S21/7*.4:%4:.1)

    Acid-Fast Stain (MA)

    LS7/EHDC?268E/C29/M2&9//+//NDO2/E&?C%2E/C29/EHDC?268

    F97=>'8/P6Q79?&8D76;//".-@034%*+,%F5:PT3,2P0+414%2P0:P,35

    F97'2=>92;F5%:PT3,2P0+414%42,33)%TA%2P0:P,3

    Mycobacteriology Culture (MB)

    LS7/EHDC?268E/C29/M2&9//+//LH922/E&?C%2E/C29/EHDC?268

    F97=>'8/P6Q79?&8D76;// ():3)/3/%*+,%F5:PT3,2P0+414% /3:32:1+)% TA%-+032P0.,%-3:I+/45

    F97'2=>92;F5%:PT3,2P0+414%/3:32:1+)

    M. tuberculosis by Molecular Methods (TB)

    B9=29/BC8D76E

    F97=>'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2: &'B6KKK pJ;K

    S//7+)%@,+/P2:%W:+%FLY &'B6KK8 pCK

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    ##

    B9=29/BC8D76E

    F97=>'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2: &'BKKKK p6HJ

    B9=29/BC8D76E

    F97=>'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2: &'BKJKK p6'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2: &'BK6KK p6JK

    B9=29/BC8D76E

    F97=>'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2: &'BK8KK p68;

    See page 4 for Product Type information.

    Analytes listed in black are regulated under CLIA 88.

    LH922/EHDC?268E/C29/M2&9//+//JD0/E&?C%2E/C29/EHDC?268

    F97=>'8/P6Q79?&8D76;// ():3)/3/%*+,%0.T+,.:+,134%:I.:%,3@+,:%+,>.)14-4%TA%>3)P4%.)/X+,%4@321345%%".-@034%1)20P/3%*P)>.0%2P0:P,34%W1)20P/1)>%A3.4:%.)/%/3,-.:+@IA:34Y%.)/%.:%03.4:%:V+%01]P1/%2,A@:+2+22.0%.):1>3)%4.-@034%@3,%A3.,5

    F97'2=>92E;F+0/\%A3.4:%.)/%eA3.4:701Q3f%+,>.)14-%1/3):1*12.:1+)?,A@:+2+22.0%.):1>3)%/3:32:1+)

    Mycology Comprehensive (MY)

    LH922/EHDC?268E/C29/M2&9//+//NDO2/E&?C%2E/C29/EHDC?268

    F97=>'8/P6Q79?&8D76;//[+:%1):3)/3/%*+,%V3:%-+P):%@,3@.,.:1+)45

    F97'2=>92E;g3.4:%.)/%eA3.4:701Q3f%+,>.)14-%1/3):1*12.:1+)

    Mycology Yeast (YE)

    LH922/EHDC?268E/C29/M2&9//+//NDO2/E&?C%2E/C29/EHDC?268

    F97=>'8/P6Q79?&8D76;//"1-P0.:3/%?"O%4.-@034%*+,%?,A@:+2+22.0%.):1>3)%/3:32:1+)5

    F97'2=>92E;?,A@:+2+22.0%.):1>3)%/3:32:1+)

    Mycology Cryptococcal Antigen (MYC)

    LH922/EHDC?268E/C29/M2&9//+//NDO2/E&?C%2E/C29/EHDC?268

    F97=>'8/P6Q79?&8D76;//'V+/,3@+,:1)>%+@:1+)4

    `P.01:.:1G3%7%^341>)3/%*+,%0.T+,.:+,134%+,%/3,-.:+0+>A%+**1234%,3@+,:1)>%:I3%t@,343)23%+,%.T43)23t%+*%/3,-.:+@IA:345%%W?+-@.:1T03%V1:I%^3,-.:+@IA:3%'34:%F3/1P-%x^'Fy%+,%)+)[email protected]/%.)/%)+)7/1**3,3):1.0%-A2+0+>A%-3/1.5Y

    (/3):1*12.:1+)%7%^341>)3/%*+,%0.T+,.:+,134%+,%/3,-.:+0+>A%+**1234%1/3):1*A1)>%/3,-.:+@IA:34%:+%.%>3)P4%+,%4@32134%03G305

    F97'2=>92E;^3,-.:+@IA:3%42,33)%TA%2P0:P,3%W`P.01:.:1G3Y^3,-.:+@IA:3%1/3):1*12.:1+)%:+%>3)P4%+,%4@32134%03G30%W(/3):1*12.:1+)Y

    Mycology Dermatophyte (DM)

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    #,

    %4'40*1(5(2.

    See page 4 for Product Type information

    Analytes listed in black are regulated under CLIA 8

    B9=29/BC8D76E

    F97=>'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2: &'BJKKK p6'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2: &'BJJKK p666

    B9=29/BC8D76E

    F97=>'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2: &'BJ6KK p68;

    B9=29/BC8D76E

    F97=>'8/LMC2 F97=>'8/@7=2 R66>&%/F9D'2

    L.43%@,+/P2: &'BJ8KK p68C

    LH922/EHDC?268E/C29/M2&9//+//JD0/E&?C%2E/C29/EHDC?268

    F97=>'8/P6Q79?&8D76;//():3)/3/%*+,%#3G30%6%0.T+,.:+,134%W.4%/3*1)3/%TA%?#(S%aEEY%@3,*+,-1)>%*P00%=z&%1/3):1*12.:1+)%+*%4:++0%4@321-3)45%%".-@03%:A@34%1)20P/3%*+,-.01)7@,343,G3/%4:++0\%N1)27&DS%4:++0%4-3.,4\%.)/%T0++/%@.,.41:3%4-3.,4X@I+:+-12,+>,.@I45%%".-@034%.,3%)+:%2+-@.:1T03%V1:I,$9!6A7%/3G12345

    F97'2=>92E;L0++/%@.,.41:3%1/3):1*12.:1+)% % &3,-.)3):%4:.1)

    M1.,/1.X?,A@:+%.):1>3)%/3:32:1+)% ":++0%V3:%-+P):F+/1*13/%.21/7*.4:%4:.1)

    Parasitology Comprehensive (PA)

    LH922/EHDC?268E/C29/M2&9//+//NDO2/E&?C%2E/C29/EHDC?268

    F97=>'8/P6Q79?&8D76;// ():3)/3/%*+,%0.T+,.:+,134%:I.:%/+% )+:%@3,*+,-%*P00%=z&%1/3):1*12.:1+)%+*%4:++0%4@321-3)45%%".-@03%:A@34%1)20P/3%*+,-.01)7@,343,G3/%4:++04\%.)/%T0++/%@.,.41:3%4-3.,4X@I+:+-12,+>,.@I45%%".-@034%.,3%)+:%2+-@.:1T03%V1:I,$9!6A7%/3G12345

    F97'2=>92E;//W)P-T3,%@3,%4I1@-3):YL0++/%@.,.41:3%1/3):1*12.:1+)%W6YM1.,/1.X?,A@:+%.):1>3)%/3:32:1+)%W8Y

    Parasitology Limited (PAL)

    LH922/EHDC?268E/C29/M2&9//+//NDO2/E&?C%2E/C29/EHDC?268

    F97=>'8/P6Q79?&8D76;//():3)/3/%*+,%0.T+,.:+,134%@3,*+,-1)>%M1.,/1.%.)/X+,%?,A@:+4@+,1/1P-% 42,33)1)>% +)%4:++0%4.-@0345% % ".-@034% .,3%)+:%2+-@.:1T03%V1:I,$9!6A7%/3G12345

    F97'2=>92E;M1.,/1.%.)/X+,%?,A@:+4@+,1/1P-%.):1>3)%/3:32:1+)

    Giardia/Cryptosporidium Antigen Detection (GI)

    LH922/EHDC?268E/C29/M2&9//+//NDO2/E&?C%2E/C29/EHDC?268

    F97=>'8/ P6Q79? &8D76; / / ".-@034% 1)20P/3% >13-4.74:.1)3/% 4-3.,4% .)/%

    @I+:+-12,+>,.@I4%+*%:I12Q%.)/%:I1)%T0++/%4-3.,45

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    #.

    B9=29/BC8D76E

    F97=>'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2: &'B8KKK p6EE

    S//1+).0%4.-@034 &'B8KKJ pJ &'B8KK6 p'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2: &'B86KK pJCE

    S//1+).0%4.-@034 &'B86KJ pBK

    S//1:1+).0%,34P0:%,3@+,:1)> &'B86K6 p;E

    See page 4 for Product Type information.

    Analytes listed in black are regulated under CLIA 88.

    Viral Antigens with Rotavirus (VA)

    LS7/EHDC?268E/C29/M2&9

    F97=>'8/P6Q79?&8D76;//S%-1)1-P-%+*%J34%@3,%A3.,m%/P.0%1-@,3441+)4%+)%'3*0+)72+.:3/%401/345%%&,+/P2:4%.,3%-3:I+/%4@321*125

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    R6&%M82;

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    Rabies

    LH922/EHDC?268E/C29/M2&9//+//NDO2/E&?C%2E/C29/EHDC?268

    F97=>'8/P6Q79?&8D76;//#1]P1/%4.-@034%1):3)/3/%*+,%,.@1/%.):1>3)%:34:%Q1:45

    R6&%M82E;()*0P3)N.%S% % ()*0P3)N.%SXL%W)+:%/1**3,3):1.:3/Y()*0P3)N.%L% % U"D

    Viral Antigens - Influenza and/or RSV (VFR)

    LH922/EHDC?268E/C29/M2&9//+//NDO2/E&?C%2E/C29/EHDC?268

    F97=>'8/P6Q79?&8D76;//#1]P1/%4.-@034%1):3)/3/%*+,%,.@1/%.):1>3)%:34:%Q1:45%%".-@034%.,3%)+:%2+-@.:1T03%V1:I%:I3%D/M%#,+$D%Q1:5

    R6&%M82;()*0P3)N.%S% % % % U"D%()*0P3)N.%L% % % % U+:.G1,P4()*0P3)N.%SXL%W)+:%/1**3,3):1.:3/Y% % %

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    R6&%M82E;()*0P3)N.%S% % ()*0P3)N.%SXL%W)+:%/1**3,3):1.:3/Y()*0P3)N.%L% % U"D

    Viral Antigens - Influenza and/or RSV (Waived Methods) (VCW)

    B9=29/BC8D76E

    F97=>'8/LMC2 F97=>'8/@7=2

    R66>&%/F9D'2

    L.43%@,+/P2:4

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    R66>&%/F9D'2

    L.43%@,+/P2: &'B8JKK p86;

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