Central Drugs Standard Control OrganisationDirectorate General of Health Services

Ministry of Health & Family Welfare(Medical DeviceandDlagnosbc Division)· .

Food and Drug Administration Bhawan. Kotla Road, New Delhi-110002

__ . ~~·_~~~~_~~~~~-~:(~~} n_. .• __ . ~ated~:- -6- S [-p--2fJ1f.--'------To .

~. Cosmos Advanced Diagnostics Ltd.,B;;;321, Somdutt Chamber-I,Bhikaji Cama Place, New Delhi.

Subject: Import Licence under the Drugs and Cosmetics Act 1940 and Rules 1945thereu nder-regardi ng.

1. With reference to your application for import licence forwarded to this office withyour letter No. Nil dated 2010512011 received by this office vide diary no23881 (FTS: 33012) dated 20105/2010 I enclose Iicence(s) No. NCD-243/11 dated- c: f."' P this 1 these Iicence(s) has 1 have been granted under the Drugs and

osme ics""Acl1940 and Rules 1945 thereunder.2. I am to point out that the provisions· of Drugs and Cosmetics Act 1940 and

Rules1945 are in addition to and not derogation of any other law for the time beingin force and as such the licence(s) issued 4nder Drugs and Cosmetics Act andRules will be in addition to and distinct fro~~ Iicence(s) which may be necessaryunder the Import Trade Control Reg~~s made of the Government of India,Ministry of Commerce. (, _V-

3. The im.port licence(s) ment~ion (([)"r5'ar.a•. (.1) above....Wi.I.1n.o..t.. acc.or.dinglY to itself 1themselves be sufficient a fify for ~mport of Drugs covered by that 1 thoseIicence(s) if under the Imp6i) rade Control RegUlations of the Commerce Ministryseparate license(s) are required for import of such drug(s).

4. I am therefore, to advise you to obtain, where necessary Iicence(s) for import ofdrugs in question under the Import Trade Control RegUlations.

5. Any literature or packing accompanying the drugs or any matter stated on the labelshQuld not contravene the provisions of the Drugs and Magic Remedies(Objectionable Advertisement) Act.

6. The Assistant Drugs Controller (India) and Technical Qfficer of the Central DrugsControl Organisation at the ports· wilrbe bfficers authorized to inspect the premisesof importers establishments for the purpose of Rule 26 of the Drugs and CosmeticsAct and Rules thereunder.

7. Please acknowledge receipt of this letter and its ellclosures.

(Dr. -; araReddy)A!!~~·l?r~g§~C,qf1tr()jJ~rm..

.. C-opyforwarded-forinformation to:1. Asstt. Drugs Controller (India), Ahmedabadl Chennail Cochinl DelhiL~Ycl_~r~I:>§_c:I!.

.....---- -- ···-KafleHa-lK-olkataf-Mumbaif-Nhava-She~,-a:· .-.- ...-.--.

FORM 10(See Rules 23 and 27)

Licence to import drugs (excluding those specified in Schedule X) to the Drugs andCosmetics Rules, 1945 -- 6 ..... .- -.·roDate: ,L '.~-. i ZOl1

Mis. Cosmo§ Advanced DltMJPostics Ltd.=-B-321, Somdutt Chal1Jbe[~ BhikajLCama ..Place, New Delhi is hereby licensed to import into India during the period for which the1iGenGe-is~nforceithe drugs spec~fledbelow, maRufactur-edGyMls. Atlas Medical, WilliamJames Ho.use, Cowley Road, Cambridg.e, CB4 .OWX,UnitedKingdom having factorypremises at MIs. Atlas Medical, Sahab-Free Zone Area, King Abdullah II Industrial City,Amman 11512 Jordan and any other drugs manufactured by the said manufacturer as mayfrom time to time be endorsed on this licence.

2. This licence shall be inforcefrom:'" 6 5 E P 2011 to ~unless it is sooner suspended or cancelled under the said rules.

3. Names of drugs to be importero1\RD CoAsperattached<1i r~".LicenSing Authority

ON:LV ~Q~ K ~'J ~~ V'

;..::. ~Place: New Delhi .< '0

_ t::J <)Date: . ~6 SEfl-ll1)SCO DSeO ~

Licensing Authority~ i ~,., ;a>'- §eallStamp

~ ~~D ;~sn.~'1:~~ .~ .'.pli:). r.jT ITiI ~"n . r. . E,wara R('/.· .. " :, .... ",I,v). . ....."... . . 3i"rllJ\) ~:. I ":. ~."'.··hPh.D."L\ ~.~ )h ~ & ~'~~!/\~c'\l.;Jn;;?" Controller~r;.-. 't!("1"'lc:ll '~'CoI"l 0 :. .~'<Ni ~,.¢.~~

Q ..... ' ..' .•.. ". 0.. Ot•. Ge~"al cd H!li~ift1 $I ..~~O!",dit;0l1s0f.LlC.en.:~~. ff cc:..sco (~lQ),Fe;:.tih,,~:~~'ces

1. A photocopy oflioence s~~ ..' .'•....~'lprOrnin:~Plac~'n ~lScI?P't1f·t~~o~_premises, and the otiginaHicence s' produced, ·Wheri~~tteqiJired.- , '''.'~

2. Each batch of drug imported into India shall be accompanied with a detailed batchtest report and a batch release certificate, duly signed and authenticated by themanufacturer with date of testing, date of release and the date of forwarding suchreports. The imported batch of each drug shall be subjected to examination andtesting as the licensing authority deems fit prior to its marketing.

3. The IicenseeshaJl be responsible for the business activities of the manufacturer inIDclicualoT1gwith the registr~tionhold~r cmg-hi~aLIthoris~clagent.

4. The licensee shall inform the licensing authority forthwith in writing in the event ofany change in the constitution of the firm operating under the licence. Where anycnangeWftffecohslltUtI6n-oflhe- fifm-IaRespTace;lne 'ciJiTeritHcence ..shall'" be.cleemecLtobe-vatidfora maximum -period.of-tbreemonths fr..omtbe ..date.onwhichthe change takes place unless, in the meantime, a fresh licence has been taken

- fromtheJicensing-auth.ority.jn the.name otthe JurrLwith th.echanged.constitution.

Licence Number: NCD-243/11 j /2E: ~ SEP Zm4This licence shall be in force from , ::- 6 SEP ZD.11- to _Names of drugs to be imported

S.No1

Product Name Intended UseMalaria Pf. Test Casstte, Whole Used for invitro testing and presence ofBlood, Serum, Plasma, Bulk Plasmodium falci arum malaria in blood.Malaria Pf/Pv. Test Cas~etteL Used for qualitative detection of circulating

ole Blood, Individually antigens of Plasmodium falciparum, PlasmodiumpOUched~BuJk vivax,Plasmodium ovale, Plasmodiummalaria in

whole-bloodUsed for the qualitative detection of antibodiesI G&I M

whole blood, serum or lasma.Used for the quantitative detection of humancardiacTroponin I in Whole blood, serum orplasma as an aid in the diagnosis of MyocardialInfarctionUsed for the qualitative detection of human

Dengue IgG/lgM Test Cassette,Whole Blood/Serum/ PlasmaBulkTroponin I Test Cassette, WholeBiood/Serum/ Plasma,Individually pouched, Bulk

6 TB Test Cassette, Serum/Plasma, Individually pouched,Bulk

7 T4 Elisa Kit, 96 Tests

9 Free T3 Elisa Kit, 96 Tests~

10 Free T4 Elisa Kit, 96 Tests

12 Toxo Plasma Gondii IgG (ToxoIgG/lgM), Elisa Kit 96 Tests

13 Rubella (lgG/lgM) Elisa Kit, 96Tests

14 Cytomegalovirus IgG/lgM (CMVI G, 96 Test

,whole blood, serum or plasma as an aid in thedia nosis of M ocardial InfarctionUsed for the qualitative detection of anti- TBantibodies (Isotypes IgG, IgM and IgA) in serumor lasma s ecimens.Use :fW the quantitative determination of totalth ine T4 in human serum.

CI for the quantitative determination of theJ'riiodothyronine (T3) concentration in humanserum.Used for the quantitative measurement of freeTriiodoth ronine IT3 in human serum.Used for the quantitative measurement of FreeTh roxine IT4 concentration in human serum.Used for the quantitative determination ofthyroid-stimulating hormone (TSH)in humanserum.Used for the qualitative detection of IgG/lgMantibodies to Toxoplasma gondii in human serumor 'Iasma.Used for the qualitative detection of IgG/lgMantibodies to Rubella in human serum or lasma.Used for the qualitative detection of IgGlIgMantibodies to CMV in human serum or lasma.

~lV ..(':~~ .£::'>4).:,; '..~~~~j

~)f.S.· (.-S'.;V:Jf3 f:~~~'1" .:if:'!!': f'Tc'

·P~l;··.:-t:;'· y' ::~

D.t"e~ ~.i;~."-t ";"\; l , :' ":-:f;~rvices•. Cf)~JC;:"j ~Hr ..,> ; ;...~o;;~~;::3ric':'.'~"'"

~({....!f? -"'OaU_':·?'~,S'.jil f)tdhr '1-1I';lnf);:

Licence Number: NCD-243/11

This licence shall be in force from ~..• 6 S EP ZOR

19 A-P1l"(PTf) Micronised SilicaPlatelet Substitute, Liquid, 10ml (200 Tests)

20 Calcium Chloride, 25 mM, 10ml/vial ,('~;'

«:'21 ASO Latex kit, 50 Te ts (2 ml

Latex, 2X ~.5 ml Controls)

22 RF Latex Kit, 50 Tests withbuffer (2 ml Latex, 2X 0.5 mlControls, 1X 10 ml Buffer 20X

23 CRP Latex Kit, 50 Tests withBuffer (2 ml Latex, 2X 0.5 mlControls, 1X 10 ml Buffer 20X

24 Taxa Latex Kit, 50 Tests withBuffer (1 ml Latex, 2X 0.5 mlControls, Glass Slide, 1X 10 mlBuffer 20X

r-'-I.tt. ~- f"'\ ?4 t- ~-

\. '.-- ~

se or e qua Ia we etection of IgG/lgMantibodies to HSV 1 in human serum or lasma.Used for the qualitative detection of IgGllgMantibodies to HSV 2 in human serum or lasmaUsed for the detection of analytes in the~___ _Leukocytes, Glucose, Ketone (Acetoacetic Acid),Bilirubin; Blood, Specific gravity, Protein,

.Ur.obWno en, Nitr~te, AscoFbic acid, and H.Used for screening for extrinsic factor deficiency,

quantitative dtermination of the extrinsiccoa ulation factors.Usearorlhe pre-surgical screening for intrinsicfactor deficiency, monitoring heparin therapy, inthe detection of Lupus Anticoagulants, andquantitative determination of Factor VIII, IX, XI,

f •• tr4nste-eoagtrl .t m.

sed for the invitro determination of prothrombintime (PT), activated partial thromboplastin time(APTT) and recalcification (plasma clotting) time,as well as in various coa ulation factor assa s.Used for the qualitative and quantitativemeasurement of antibodies to Antistreptolysine-o in human serum.Used for the qualitative and semi-quantitativemeasurement of RF in human serum.

Used to measure CRP RF in human serumqualitatively and quantitatively.

Used for the qualitative and semi-quantitativemeasurement of Toxoplasma gondii antibodies inhuman serum.

Date: .•.•.r C: i-p ZOR~

•••• n""~

Licensing Authority-Se-a1IStamp

RJ ~ ~iI ~ ~ Q;Ttf, ~. ~. ~l.Dr. $. E.wflra Reddy M."~ Ph.D.

~"~ ~/AS!tt.Dru9"· (."ntreller~.~ 11~1chr;i.'Fl

D~. e-n-.t cA Ma.::h S~r,'ic'!!sCOGCO (HQ), FDA c3hiJ·.••~n

KoU. Road, New Delhi-110002

Central Drugs Standard Control OrganisationDjF'9~J()rat~dG_~n~J@IQfH~~ltbuS~n'ie~s

Ministry of Health & Family Welfare(Medical Device and Diagnostic Division)

Food and Drug Administration BhawanKotla Road, New Delhi -110002

Dated::- 6 S EP lOti.

TO~ Is. Kan Health Care,---314, AgrawalArcade,

Plot N02, CU Block,Pitam pura.Delhi- 110038.

SUbject: Issue of an Endorsement No. 01 to Form 10 License No. NCD-214/11dated 20/07/2011 valid upto 19/07/2014 -regarding.

Sir •~t'"Please refer to your application No. ~/FUjirebiO/FORM 10/15/10-11 dated

16/02/2010 and received by this office MJ)lary NO.7881dated 18/02/11, replyreceived by this office vide Diary No~~ (FTS-49157) dated 20107/11 and 35248(FTS 50827) dated 27107/2011 ~iJ~sUbject cited above.

Endorsement No. 01 to Form 10 License No. NCD-214/11 dated20107/2011 valid upto 19/07/2014 for the import of drugs manufactured atM/s.Fujirebio Diagnostics AB,E/of Linda/vs gata 13,414 55 Gothenburg,Sweden enclosed hereby.

c£jl;~~(Dr. S. Eswara Reddy)

Asstt. Drugs Controller (I)

Copy forwarded for information to:f.Assft.DrugsCOl1troHeY Tlnoiar, Ahmed-abacI Chel1l1ai/- Cocfiin/ Delhi!

.f1y-derabad/~Kandla-/KolkatafMumbaj/--NnavaccSAeva-;-

FORM 10(Endorsement No.1)(See Rules 23 and 27)

Licence to import drugs (excluding those specified in Schedule X) to· the Drugs andCosmetics Rules, 1945

Lice~ce.....:::, c: C· c: ~Hwer:.Date. • v u ~ j _;J f

MI.s-.Kan ..HeaJth.c.ar~3.14,Agr.awaJ. Arcade, Plot No~2, CUBJock, Pitampura,De/hi-110038is hereby licensed to import into India during the period for which theiicence is in force, the drugs specified below, manufactured by Mls.FujirebioDiagnostics AB,E/of Linda/vs gata 13,41455 Gothenburg ,Sweden.

2. Ttlis Endorsement No. 01 shall be in force from .::~; ::....E; ;= f!~i to19/07/2014 unless it is sooner suspended or cancelled under the said rules.

Place: New Delhi iE'Date : \'~_E:_!:" ?(bsco

'\' ~ ::Hi ifflif. 61. iffl. ~l Iwera Reddy M.Ph ;On.D.· , : I'

..,>.-. IA:3tLDrlJgs Controller tX"lqj ;:J('II::!~~TI:"'m ~I of Heai,h ServIC9S t

1. ~r~~f:~~~~~do:hJ6Tiginal'licence:Sl1a \'£ . ' .' . ,]tt1!~g~ttte~-~002 ~2. Each batch of drug imported into India shall be accompanied -With-1i"dMatlM-"""'-

batch testreport and -abatch release certificate; dUlysigned and authenticated bythe manufacturer with date of testing, date of release and the date of forwardingsuch reports. The imported batch of each drug shall be sUbjected to examinationand testing as the licensing authority deems fit prior to its marketing.

3. The Hcensee shCl11 be r~~pon~iblefor the business activities of the manufacturerinl ndia along w~ththeregistrat~onholderandhisauthor~sed-agent.

4. The licensee shall inform the licensing authority forthwith in writing in the event ofany_.changein the.constitutLQnQ.ttb.eJirmQ'pJara_tloguo.deLtheJigelJce.Wtleret;lnychange in the constitution of the firm takes place, the current licence shall be

.. deemed-tobevalidioramaximam perrod·oftfTreemonthsfromthe ·dateon whichthe change takes place unless, in the meantime, a fresh licence has been takenfromihe1icensingauthorityin1he nameofthefJrmwith ·the-changedconstitution;

fORM 1()(etnh"r~ement No,1)Licence Number: NCD-214/11 .

This licence shall be in force fromNames of dru s to be im ortedS.No Product Name

CanA CA 19-9 EIA(productNo-120-10=eanAgGA 15-3 EIA(product-~-2-00.40.CanAg PSA EIA(product No

Intended UseFor quantitative determination of the cancerassocI:F:OtqlJantjt-clti"~c;I~t~rmiriationof the cancer~s~sociatedwith Breast cancer in serumFor quantitativedeterminafio·nofTotarpSAPr~tate cancer in buman serumFor quantita Ive e ermm

rostate cancer in human serumfor-quantitative determination of ovariancancerFor quantitative determination of the cancer•asso' d anti en CEA in serum

termination of a-F rotein AFP in human serum

n enzyme immunometric assay for quantitativedetermination of HE4 in human serumAs an assayed quality control serum to monitorthe accuracy of laboratory testing for Neuronspecific Enolase (NSE),S100B protein andS uamous Cell Carcinoma Anti en SCCA

Tumor Marker Control(produc As an assayed quality control serum to monitorNo-108-20) the precision of laboratory testing procedures fo

the analysis of AFP,CA 15-3,CA 19-9,CA -125,CEA,Ferritin ,HE4,PSA and Free PSA

ITEM(S) TEN ONLY

CanAg Free PSA EIA(producNo-350-10CanA1fCA 125 EIA(prouuctNo-400-10CanAg CEA EIA(product No-401-10

600-10HE4 EIA (product N0-404-~

CanCheck Tumor MaControl Serum (product No-107-20)

Central Drugs Standard Control OrganisationDirectorate General of Health Services ,

Ministry of Health & Famil Welfaree Ica eVlceand Diagnostic Division)

Food and Drug Administration BhawanKotla Road, New Delhi-110002

~- ..~- -~---.----------------Dated:~SEP--2tJtt~--- ---.To ~S .•~!J1.9-Diajl!lo~li~~y.~t~!1'H!J:))tt.Ltd., .

1-srFI()or,Manikodi$rinivasa Nagar,Seevaram, Chennai-96.

Subject: Import Licence under the Drugs and Cosmetics Act 1940 and Rules 1945ther-eunder-regarding.

1. With reference to your application for import licence forwarded to tfiis office withyour letter No. Nil dated 21702/2011 received by this office vide diary no17391(FTS:24418) dated 13/04/2011 I enclose Iicence(s) No. NCD-100/08 dated

__ C. C'-,-o ZRt' this 1 these licence(s) has 1 have been granted under the Drugs and- e'osnrefics m-940 and Rules1945 thereunder.2. I am to point out that the provisions of Drugs and Cosmetics Act 1940 and

Rules1945 are in addition to and not derogation of any other law for the time beingin force and as such the licence(s) issued under Drugs and Cosmetics Act andRules will be in addition to and distinct fr~ny Iicence(s) which may be necessaryunder the Import Trade Control R~tO~::>n-s made of the Government of India,Ministry of Commerce. .."'~

3. The import licence(s) mea~~ ... ,.n p.a..ra...(1....). a.b.o..v...e.. Will.n...o...t a.cc..ordingIY to itself 1themselves be sUfficieq}~uthority for import of Drugs covered by that 1 thoselicence(s) if under the Import Trade Control Regulations of the Commerce Ministryseparate license(s) are required for import of such drug(s).

4. I am therefore, to advise you to obtain, where necessary Iicence(s) for import ofdrugs in question under the Import Trade Control Regulations.

5. Any literature or packing accompanying the drugs or any matter stated on the labelshould not contravene the provisions of the Drugs and Magic Remedies(Objectionable Advertisement) Act.

6. The Assistant Drugs ControllE!r{Ingial and T~c;bDjc_alQffic~rQf the_Central DrugsControl Organisation at the ports will be Officers authorized to inspect the premisesof importers establishments for the purpose of Rule 26 of the Drugs and CosmeticsAct and Rules thereunder.

7. Please acknowledge receipt of this letter anditsenclosures.~~i1J1tuIlY

(-ef;~~ESWara-Reddy)Asstt·P •...LJcg~_~Q~!I'QH~L(I)

Copyf6riliardedfor Triformafionfo: ...-1. Asstt. Drugs Controller (India), Ahmedabadl Chennail Cochinl Delhi! Hyderabadl

.Kandla IKblkatal Mumbail Nhava Sheva.

FORM 10(See Rules 23 and 27)

Licence to import drugs (excluding those specified in Schedule X) to the Drugs andCosmeftcs Rules, 1945

Date: ~ 6 SEP ZOl1Mis. Euro Diagnostic Systems Pvt. Ltd., 1st Floor, Manll!oc!L~tjlJivasa N;m~r,.

-Seevaram, -clfimnai-96 is hereby licensed t6Tmport into-India during the period for which thelicence isin force, the drugsspecifiedbelow, manufactured by Mis. SPINREACT S.A.U.,.Ctr!! ....Sal1~~..f;QlgmEt.Z-.17176_SaatEste.v.eDe..Bas.(.Gir.ona}rSpain.arldany·ottler drugsmanufactured by the si:lid manufacturer as may from time to time be endorsed on thislicence.

. . . ~ C. <:': t"D '10·11 f:5 SEP 20142. This licence shall be In force from .\.1 U L \ L to _unless it is sooner suspended or cancelled under the said rules.

?>~f~?j.

~-o, Z

Date: -------- D5CO /db.•. .. Licensing Authority

~ -";""'~'~''I<o'''''';:';''?'"L';'SAaUStam.pc:.'-', ../;".'~ ,. "i <'''g:,'''''' . ~_""J 'If, '':'~T

'I'~ ~-="'H ·~~f:i;f~'l~J~;n~:;;j;1. A photocopy of licence s. . " 0 nentf~€~~~art)efi~liie;r. I"'~: ~

premises, and the original lice . produced,. en~ve'f reqUlr~o. ew Oel~t,'10()O.~~', , ~2. Each batch of drug imported into India shall be asqo~~nJ~'O""w1th.':l:f·lteta1~'d:batdir,·~·,~,.·\;"h.J

test report and a batch release certificate, duly signed"and authenticated by themanufacturer with date of testing, date of release and the date of forwarding suchreports. The imported batch of each drug shall be subjected to examination andtesting as the licensing authority deems fit prior to its marketing.

3. The licensee shall be responsible for the business activities of the manufacturer inIndia along with the registration holder and his authorisedagent

4. The licensee shall informthelicensil1gC3uthorityforthwith in writing in the event ofany change in tfte constitution of the firm operating under the licence. Where anychange in the constitution of the firm takes place, the current licence shall bedeemed to be valid for a maximum petiocfoftliteerilonths from the date on whichthe ~ha,.,ge takes place w'lless,in the meantimeTaJresh licence has been- t.akenfrom the licensing authority in the name of the firm with the changed constitution.

Licence Number: NeD-100/08

This licence shall be in force from .:: 6 S EP Z 011Names of drugs to be impo~d'

1/5

tojS SEP2014

S. No. ProductName Intended Use1. Bilirubin Direct and Total Used for the quantitative determination of

Bilirubin-------_ .. _----- L:···' UreaGLTIHKinetic Used for ihe quantitative determination of

.,Ur.ea

3. Jl[~i!a~I1h.eJQt ....Used fOI.the quantitative determination ofUrea '"

,

A Copper Usedforthe auantitative determination of, Copper5. Cholinestrase- Dibucaine Used for the quantitative determination of

Cholinestrasewith ibucaine inhibition6. Creatin Kinase Used for the quantitative determination of

Creatin Kinase (CK)7. Creatin Kinase-MB Used for the quantitative determination of

~ . v,' ,_ llAD

8. Creatinine Used for the quantitative determination ofcreatinine

9. LDH Used for the quantitative determination ofLacta~~hydrogenase

10. LDL Cholesterol ~~r the quantitative determination of~ LG.-'tholesterol

11. Alpha Amylase ,,~~\(,J"rtJsed for the quantitative determination of a.Amylase

12. Albumin V Used for the quantitative determination ofAlbumin

13. Fructosamine Used for the quantitative determination offructosamine

14. Glucose Used for the quantitative determination ofGlucose

15. Haemoglobin Used for the quantitative determination ofHaemoglobin

16. Lactate Used for the quantitative determination ofLactate

17. Total Protein Used for the quantitative determination ofTotal Protein

18. Protein Urine & CSF Used for the quantitative determination oftotal urinary and CSF protein

7:7,L: "~~f~ ':j ~<-:~; )":r<,\ J":'~. -":. ~, ',J ~:.;)J.- ;~_ ::"::_.cl!:!·1~l-' "~_F!:T'>' .~,~;.._~_>-'.:__~_'-

,:GT ..I{f ::'.f_,.,~,,~~, ~-;.,-.: .•.~' . ~j~, ,I~ .F'·, , -·.'\~a"i;-):~'", -:-:'7'1 .---;-'-',,.:;;." .'

Licence Number: NCD·100/08 2/5

This licence shall be in force from ~ to _~_,,~_:5_·_S_E_~_\ _2_0_1_4_Names of drugs to be imported,

19. Uric Acid

20. Zinc

'~~1r: -CcircIum ...22. Chloride

23. Iron

24. TIDC

25. Magnesium

26. Cholesterol

27. HDL Cholesterol

28. Phospholipids

29. Total Lipids

30. Triglycerides

31. Acid Phosphatase ~«32. Bovine Control Normal

33. Bovine ControlPathol0 ical

34. Human Control Normal

35. Human ControlPathological

36. Alkaline Phosphatase

37. GPT(ALT)

38. QQT(AST)

39. Ch6lillestel-ase

Used for the quantitative determination ofuric acidUsed for the quantitative determination ofZincUsed for the quantitative determination ofCalcium.DsedJor-the.quantitative determinatioo.()f·Chloride ionUsed for the uantiIronTotal iron binding capacity (TIDC)saturatin -reci itatill aentUsed for the quantitative determination ofMa esiumUsed for the quantitative determination of

Used for the quantitative determination ofHOL CholesterolUsed for the quantitative determination ofPhis holi dsUsed forJ\te quantitative determination ofTo ~~

or the quantitative determination ofnglycerides

Used for the quantitative determination ofAcid Phos hatase.Serum Control multicomponent for clinicalchem.istry assaysSerum Control multicomponent for clinicalchemistry assaysSerum Control multicomponent for clinicalchemistry assaysSerum Control multicomponent for clinicalchemistry assaysUsed for !heqtlalltita!ive determination ofAlkaline Phos hataseUsed for the quantitative determination ofAlanine AminotransferaseUsed for the quantitative determination ofAs artaeAminotransferaseUsed for theql.lalltitative determination ofCholinesterase

ii'· ft~~.~~·'"·~·il.. er~s. E'lwera P.edd~',"Vt, 1~f1.D.. ~ ~ ~~~,(l)ll\ss\t.~\r·:g$Controller)

WAUl ~Tr 'r:;if;jc~:·!7r;•• Ole. o.rMlr.' of Hao:dh ~!!)r",ll::.s

L CDSCO (HQ), n;·.:... ei";tlwl1nK~B Road. New Dethi·110002

_-.._.__. .' __ tw. F _. ; '-"

C r- - ,Z,> fl.., ~,1, toutrj ~u!This licence shall be in force fromNames of drugs to be imported

40. Potassium Used for the quantitative determination ofPotassium ion

41. Sodium Used for the quantitative determination ofSodium ion

42. Gamma-GT Used for the quantitative determination of.·(Jamma Glutamyl transferase

...... 43. -- -- .HBDH .... Used.for ..the.quantitati:v.e..determination .of 0.-

. .. ..... . " . .. .l:lydr.oxybutyrate dehydrogenase44. ImmunoQ'lobulin G Used for the auantitative determination of

Immunoglobulin G45. Immunoglobulin A Used for the quantitative determination of

IrtitIlunoglubulin A46. , Immunoglobulin M Used for the quantitative determination of

Immunoglobulin M47. ASO- Turbilatex Used for the quantitative determination of.•.: . A~48. CRP- Turbilatex Used for the quantitative determination of C-

Reactive Protein49. RF - Turbilatex Used fW the quantitative determination of

,Rftt~atoid Factors50. Lp(a)- Turbilatex ',.. ", -lJsed for the quantitative determination of

'I."U'" Lipoprotein (a)51. p 2-m Turbila~~'{ ~ Used for the quantitative determination of P2-

microglobulin52. IgE- Turbilatex Used for the quantitative determination of

immunoglobulin E53. Myoglobin- Turbilatex Used for the quantitative determination of

Myoglobin54. Microalbumin- Turbilatex Used for the quantitative determination of

microalbumin55. Ferritin- Turbilatex Used for the quantitative determination of

Ferritin56. Complement C3 Used for the quantitative determination of

human complement C357. Complement C4 Used for the quantitative determination of

human complement C458. Cocaine Used for the qualitative detection of Cocaine

in urine.59. Opiates/ Morphine Used for the qualitative detection ofQpiate/

Morphine in urine

This licence shall be in force from.Names of drugs to be imported

SEP 20714/5

to & 5 SEP 2014----------60. Benzodiazapine Used for the qualitative detection of

Benzodiaza ines in urine61. Methamphetamine Used for the qualitative detection of

Metham hetamine in urine62: -- -G1-cateOHaemo-]obin--HirliivltroTjse63. AFP Calibrator Used for the quantitative determination of

feto JQiein_64. ASO Calibrator Used for the quantitative determination of

anti-str 01 sine65. CRP Calibrator Used for the quantitative determination ofC-

Reactive Protein66, RF Calibrator Used for the quantitative determination of

Rheumatiod Factors67. ASO-CRP-RF Control L Used for the quantitative determination of

ASO/CRPIRF

69. Lp(a) Calibrator

70. Lp(a) Control

71. ASO Latex SlideA glutination

72. CRP L~te~ Slide ()Ag lutmatlon -

73. RF Latex SlideAgglutination

74. Lipase

75. Apolipoprotein- Al

76. Apolipoprotein- B

77. APTI

78. Prothrombin

79. Fibrinogen

80. CRP Ultra Calibrator

ASO/CRPIRFUsed for the quantitative determination ofLi 0 rote in (a)Used for Huantitative determination ofLi n (a)

e or the quantitative determination ofti- stre tolysine 0

Used for the quantitative determination of C-Reactive roteinUsed for the quantitative determination ofRheumatoid FactorUsed for the quantitative determination ofLi aseUsed for the quantitative determination ofA oli 0 rotein A IUsed for the quantitative determination ofA oli 0 rotein BUsed for the quantitative determination ofActivated Partial Thrombo lastin TestUsed for the quantitative determination ofProthrombin timeUsed for the quantitative determination ofFibrino enUsed f{)rthe quantitative determination ofC-Reactive Protein

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This licence shall be in force fromNames of drugs to be imported

- 6 ~~p 2011E-.5 SE.p. Z01~/5

81. CRP Ultra Control Used for the quantitative determination ofCRP- Ultra

82. HbA 1c Multicalibrator Used for the quantitative determination oflycated haemo lobin

·83.eoagulatibfi Calibrator· .. Use-ifIor-the"quailtltatlvedetermination ofColation Factor

84. C()Cl:~ICl:!i(mC:QI!trolN .1,1sed.iQIJ:bequantitativedeterminatiQnof.CQa JatiQn Factors

85. Coagulation Control P Used for the uantitative determinafCoa ulation Factors

86. Microalbumin Control Used for the quantitative determination ofmicroalbumin

87. Microalbumin Calibrator Used for the ~ itative determination ofmicroalb

88. HDLILDL Calibrator Used quantitative determination of

ITE~()

Place.':New Delhi

~ 6 SEP 2011Date: _

Licensing_ Authority.Seal/Stamp

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