List of HIV Diagnostic Kits Approved For Blood Bank Use Till March, 2012

INDIAN MANUFACTURER
S.NO. NAME OF KIT 1 HIVCHEX 2 MICRO LIS A HIV 1 12 3 MICRO LIS A HIV Ag & Ab 4 ELISCAN HIV 1 12 5 ELIK NAME OF MANUFACTURER MIS XCYTON DIAGNOSTIC PVT. LTD.BANGALORE MIS J. MITRA & CO. LTD., N.DELHI MIS J. MITRA & CO. LTD., N.DELHI MIS RANBAXY DIAGNOSTICS, NEW DELHI MIS CADILA PHARMACEUTICALS MEHSANA CATEGORY ELISA ELISA ELISA ELISA ELISA

6 ENZAIDS HIV 1 I 2

MIS SPAN DIAGNOSTIC LTD. SURAT

ELISA

7 VIRA-LISA HIV (ELISA) 8 ERBA LISA HIV 1+2

MIS ENDOCRINE TECHNOLOGIES INDIA ELISA PVT. LTD. SECUNDERABAD MIS TRANSASIA BIOMEDICAL LTD., DAMAN ELISA

FIRST RESPONSE TO HIV MIS PMC INDIA PVT. LTD. DAMAN 1.2.0 CARD TEST

RAPID

10 COMB. AID HIV 1 12

MIS SPAN DIAGNOSTICS LTD. SURAT

RAPID

11 HIV TRI DOT

MIS J. MITRA & CO. LTD. NEW DELHI

RAPID

12 RETROCHECK HIV- WB 13 RETROGUICK HIV

MIS QUALPRO DIAGNOSTICS GOA MIS QUALPRO DIAGNOSTICS GOA

RAPID RAPID

14 HIVCOMB

MIS J. MITRA & CO. LTD.NEW DELHI

RAPID

15

P AREEKSHAK HIV V2 SPOT TEST

MIS. BHAT BIOTECH INDIA (P) LTD., BANGALORE

RAPID

16

P AREEKSHAK HIV V2 ELISA P AREEKSHAK HIV V2 TRILINE CARD TEST

-DO-

ELISA

17

-DO-

RAPID

18 HIV I & II 19 RETROLISA 3.0(HIV IIII) 20 HIV I & II 21 ELECSYS HIV COMBI

Mis APEX DIAGNOSTICS,MUMBAI-l Mis QUALPRO DIAGNOSTICS,GOA Mis IBEEJA Y TRADE LINKS,MUMBAI Mis ROCHE DIAGNOSTICS INDIA PVT.LTD.,MUMBAI

RAPID ELISA RAPID ELISA WESTERN BLOT IMMUNOCOMB BASED RAPID RAPID ELISA RAPID ELISA ELISA RAPID

22 HIV 1 & 2 WESTREN BLOT J.MITRA & CO. PVT. LTD. 23 HIVEIACOMB 24 DIAGNOS HIV Bl-DOT 25 HIV CHEK Rapid Test Kit 26 Qualisa HIV 4.0 27 HIV TRI-DOT+Ag 28 HIV Ag & Ab CLIA 29 HIV (1+2) CLIA 30 Aidscan HIV TRISPOT TEST J.MITRA & CO. PVT. LTD. J.MITRA & CO. PVT. LTD. Mis Aspen Laboratories, Pvt. .Ltd., Delhi 110033 M/s Qualpro Diagnostics, Goa M/s J Mitra & Co. Ltd. -Do-DoM/s Bhat Bio-Tech India Pvt. Ltd, Bangalore M/s Span Diagnostics Ltd. Gujarat

Signal HIV Flow Through 31 HIV 1+2 Spot Immunodot Test Kit

RAPID

32 Erba Sure HIV Gen 4

M/s TRANSASIA BIOMEDICAL LTD., ELISA DAMAN M/s SD Bio Standard Diagnostics Pvt. Ltd., SD BIOLINE HIV-1/2 3.0 RAPID 33 RAPID Plot No. 266 Sector-6 IMT Manesar, KIT Gurgaon, Haryana M/s SD Bio Standard Diagnostics Pvt. Ltd., 34 SD HIV-1/2 ELISA 3.0 KIT ELISA Plot No. 266 Sector-6 IMT Manesar, Gurgaon, Haryana

Imported Kits
S.NO. NAME OF KIT
1 MUREX HIV-1.2.0 (GE94/95) 2 MUREX HIV -2 (GE 22) MUREX HIV Agi Ab3 COMBINATION (GE 41142) 4 HIV-l/HIV-2 GO EIA 5 IMx HIV-l/HIV-2 III PLUS 6 AxSYMHIVV2 7

NAME OF MANUF ACTURER

MIS MUREX BIOTECH LTD. U.K.

CATEGORY
ELISA ELISA

MIS MUREX BIOTECH LTD. U.K. MIS ABBOTT GMBH & CO. GERMANY MIS ABBOTT GMBH & CO. GERMANY MIS ABBOTT GMBH & CO. GERMANY

ELISA ELISA ELISA ELISA ELISA

AxSYM HIV 1 12 GO REAGENT MIS ABBOTT GMBH & CO. GERMANY PACK WITH CONTROLS

AxSYM HIV Ag/Ab COMBO 8 REAGENT PACK WITH CONTROLS 9 PRISM HIV 0 PLUS ASSAY KIT WITH HIV 0 PLUS W ASH KIT

MIS ABBOTT GMBH & CO. GERMANY

ELISA

MIS ABBOTT GMBH & CO. GERMANY

ELISA

HIV V2 ELISA TEST KIT (HIVASE MIS GENERAL BIOLOGICALS CORP. TAIWAN V2) MIS ROCHE DIAGNOSTICS GMBH WERK 11 COBAS CORE HIV COMB I. PENZBERG, GERMANY GENEDIA HIV V2 ELISA 3.0 MIS GREEN CROSS LIFE SCIENCE CORP. (GCLS 12 TEST KIT KOREA VIRONOSTIKA HIV UNIFORM II MIS BIOMERIEUX B.V.BOSEIND THE 13 Ag/Ab NETHERLAND 10 14 15 VIRONOSTIKA HIV-I ANTIGEN MICROELISA SYSTEM HIV 1 I 2 ELISA KIT (SD HIV 1 12 ELISA 3.0) MIS ROCHE MOLECULAR SYSTEMS INC. USA MIS STANDARD DIAGNOSTICS KOREA MIS BIO-RAD LABORATORIES, STEENVOORDE FRANCE MIS ORTHO CLINICAL DIAGNOSTICS USA MIS ZHONGSHAN BIO- TECH CO. LTD. CHINA

ELISA ELISA ELISA ELISA ELISA ELISA ELISA ELISA ELISA ELISA ELISA ELISA ELISA ELISA ELISA

16 GENSCREEN HIV 1 12 V.2 17 ORTHO HIV -lIHIV -2 Ab CAPTURE ELISA TEST SYSTEM

18 ANTI-HIV I + 2 ELISA KIT 19

HIV I I 2 ELISA KIT (DETECT HIV MIS ADALTIS INC. CANADA V.I) ANTI - HIV I + 2 REAGENT 20 PACK WITH CALIBRATOR & MIS ORTHO CLINICAL DIAG. U.K. CONTROLS 21 BIOELISA HIV I 12 TEST KIT 22 HIV - EIA MIS BIOKIT S.A. SPAIN MIS ANI LAB SYSTEMS OYFINLAND

23 HIV I + O/2Ab SCREENING MIS EQUIPAR S.R.L. ITALY HIV I I 2 ELISA KIT 24 (RECOMBIGEN HIV I 12 MICROPLATE EIA) CHIRON RIBA HIV-lIHIV- 2 25 STRIP IMMUNOBLOT ASSAY (SIA) 26 HIV BLOT 2.2 NEW LA V BLOT I (CONFIRMATORY) NEW LA V BLOT II 28 (CONFIRMATORY HIV WESTERN BLOT TEST 29 (QUALICODE HIV 1/2) 27 MIS CAMBINDIA BIOTECH KITS (PVT.) LTD.HARYANA MIS CHI RON CORPORATION USA MIS GENE LABS DIAGNOSTIC PTE LTD. SINGAPORE

ELISA WESTERN BLOT

MIS Bio-Rad LaboratoriesLaboratories,France WESTERN BLOT MIS Bio-Rad Laboratories,France MIS IMMUNETICS INC. USA WESTERN BLOT WESTERN BLOT PCR PCR PCR PCR

30 AMPLICOR HIV-I MONITOR KIT MIS ROCHE MOLECULAR SYSTEMS INC. USA 31 AMPLICOR HIV-I KIT 32 COBAS AMPLICOR HIV-I MONITOR KIT MIS ROCHE MOLECULAR SYSTEMS INC. USA MIS ROCHE MOLECULAR SYSTEMS INC. USA

33 COBAS AMPLISCREEN HIV-I KIT MIS ROCHE MOLECULAR SYSTEMS INC. USA 34 VIDAS HIV DUO 35 VIDAS HIV p24 II VIDAS HIV p24 36 CONFIRMATION IMMUNOCOMB II HIV 1 & 2 37 COMBIFIRM MIS BIOMERIEUX S.A. FRANCE MIS BIOMERIEUX S.A. FRANCE MIS BIOMERIEUX S.A. FRANCE MIS ORGENICS LTD. ISRAEL

WITHVIDAS EQUIPMENT IMMUNOCOMB BASED

38 GENSCREEN PLUS HIV Ag-Ab IMMUNOCOMB II HIV 1 &2BISPOT HIV 1 12 RAPID TEST KIT 40 (BIOLINE HIV 1 12 3.0) HIV V2 RAPID TEST KIT 41 (DEVICE) 39 42 HIV I & II RAPID CASSETTE 43 HIV CHECK TRILING RAPID TEST KIT(FINISHED)

MIS. BIORAD LABORATORIES, FRANCE MIS ORGENICS LTD. ISRAEL MIS STANDARD DIAGNOSTICS KOREA MIS ACON BIOTECH (HANGZHOU) CO. LTD. CHINA MIS IND DIAGNOSTIC Inc., 1629 Fosters Way,Delta,BC,CAN ADA MIS ASAN PHARM. CO. LTD.73, YOUNGCHUNRi,KOREA MIS Bio Focus Co. Ltd., 405 Gocheondong,Uiwang- si.Gyeonggi -do,437 -801

ELISA RAPID RAPID RAPID RAPID RAPID RAPID

44 HIV 112 Rapid Cards Test Kits l. Versant HIV-1 RNA 3.0 Assay (bDNA) 2. Versant HIV -1 Genotyping 45 Kit. 3. Advia Centaur Enhanced HIV.

Mis Siemens Medical Solutions Diagnostics,333 Convey St., East Walpole, MA 02032-1597, USA. (Initially the name was Mis Bayer Healthacare PCR LLC, 333 Convey St., East Walpole, MA 020321597, USA)

46 HIVY2 Ab ELISA Kit

Mis. MBS SRL Medical Biological Services (Italy) ELISA via Divittorio 307/5, Serto S giovani (Milano)

47

Mis. Calypte Biomedical Corporation 1500E, 1. Calypte HIV-1 BED incidence Gurde Drive Suit A, Rockville, Maryland, 20850 EIA EIA- IgG-Capture HIV - EIA (USA)

1. Intitially the product name was Calypte- HIV -1/2 OMIT rapid test. Now the product 48 name has been changed to" Aware TM - OMT HIV-1/2 Rapid Test" 49 1 HIV I & II Rapid Cassette Diagnostic Kit

Mis. Pacific Biotech Co. Limited, 42, Moo 4, Petchaboon Chalianglub Road, bnapa, Muang, Petchaboon -67000, Thailand

RAPID

Mis. IND Diagnostics Inc, Delta, Canada

RAPID

50 1. HIVY2 Rapid Card Test

Mis. Beijing Geneses Biotech Inc, Baijing Daxing Industry development Zone, Keyuan Road, 18, RAPID Beijing, China -102600

1. HIV Check triline Rapid Test Mis. Asan Pharma Co. Limited, 73, Y oungchun Kit(Finished) RAPID/IMMUNO51 Ri, Donglan H yeon Hwaseong-ei, gyeonggi- do, Immunochromatography CHROMATOGRAPHY Korea Lateral Flow) 1. HIV 1/2 Rapid Card Test Kit(Qualitative 52 Immunochromatography assay) 1. Bioline HIVY2 3.0 (HIV 1/2 53 Rapid Test 2. SD HIVY2 ELISA 3.0 (HIV 1/2 Elisa Test Kit). 54 Mis. Bio Focus Co. Limited, 405, Goecheon dong, wiwang-si, gyeonggido, 437 -801, Korea RAPID/IMMUNOCHROMATOGRAPHY

Mis. Standard Diag Inc, 156-68 Hangal, GiheungRAPIDIELISA eup, Kyonggi-Do, Korea

Mis. Intec Product Inc, 332 Xinguang Road, 1. Rapid HIV Y2 Test Kit 2. Elisa Xinyung indo Area, Haicang, Xiamen, 361022, HIV Y2 Test Kit P.R. China

RAPIDIELISA

55 Insti HIV Antibody Test Kit

Mis. Biolytical Laboratories, 11 08-13351 Laboratories, 11 08-13351 Commerce Park Way, Richmong, British Clumbia V6V 2 x 7, Canada Mis. Intec Products Inc. 332, Xinguang Road, Xinyang Area, Haicang Xiamen, 361022 (China Mis. Ani lab System Oy, Tiilitie 3 Fi-01720, Vantaa, Finland

ELISA

56

I.ELISA HIV Kit 2. Rapid HIVY2 Kit

ELISAIRAPID ELISA

57 1. HIV ELISA 58 Med Mira HIV Rapid test Kit lArchitech HIV Agi Ab Combo 59 reagentKit, calibrators & controls 60 1. Qualicode HIVY2 test kits 61

Mis. Med Mira Inc, Suite No.1, 155 Chain Lake RAPID Dr. Halifax, NS B3S 1 B3 Canada. Mis. Abbott Ireland Diag. Div, Finisklin Business ELISA Park, Sligo, Ireland Mis. Immunetic Inc, 27, dryydock avenue, 6th floor, Boston HA 02210 (USA) ELISA PCR

1. Abbott Real time HIV -1 Mis. Abbott Molecular Inc, 1300 E, Toufy callibrator kit. 2. Abbott avenue, Des Plaines IL 60018, USA Real time HIV -1 control kit Mis. Inverness Medical Japan Co. Limited, Japan. (Manufacturing premises:Abbott Japan co. Limited,Matsuda Plant-2, matsuhidai, Matsudo-shi,278 chiba-270-2214, Japan)

1. Determine HIVY2 and 62 Determine

ELISA

List of HBsAg Diagnostic Kits Approved For Blood Bank Use

Indian Manufacturer
S.NO.

NAME OF KIT
1 HEPALISA HBsAg 2 MICROSCREEN HBsAg 3 ELISCAN HBsAg 4 VIRA-LISA HBsAg 5 ERBA - LISA TEST HEPB 6 VIRUCHEK HBsAg (ONE STEP TEST FOR HBsAg)

NAME OF MANUFACTURER
MIS J. MITRA & CO. LTD. NEW DELHI MIS SPAN DIAGNOSTIC LTD. SURAT MIS RANBAXY DIAGNOSTICS NEW DELHI MIS ENDOCRINE TECHNOLOGIES INDIA PVT. LTD. SECUNDERABAD MIS TRANSASIA BIOMEDICAL LTD. DAMAN MIS ORCHID BIOMEDICAL SYSTEMS GOA MIS J. MITRA & CO. LTD. NEW DELHI Mis APEX DIAGNOSTICS,MUMBAI-1 Mis SHATHA BIOTECHNIES LTD.,HYDERABAD Mis IBEEJA Y TRADE LINKS,MUMBAI Mis ROCHE DIAGNOSTICS INDIA PVT.LTD.,MUMBAI Mis SPAN DIAGNOSTICS LTD,UDHNA,SURAT

CATEGORY
ELISA ELISA ELISA ELISA ELISA RAPID RAPID RAPID ELISA RAPID ELISA ELISA

7 HEPACARD 8 HBsAg 9 SHANTEST - HBsAG 10 HBsAg Kits 11 ELECYCS HBsAg IMMUNO12 CHROMATOGRAPHIC HBsAg

13 HBsAg CLIA 14 HEPALISA ULTRA 15 Erba Lisa Sen HBsAg 16 17 Hepa Scan HBsAg Card Test Kit

M/s J Mitra & Co. Ltd. M/s J Mitra & Co. Ltd. M/s Transasia Biomedicals Ltd, Daman

ELISA ELISA ELISA

M/s Bhat Bio-Tech IndiaPvt. Ltd, Bangalore RAPID RAPID

M/s SD Bio Standard Diagnostics Pvt. Ltd., SD BIOLINE HBsAG RAPID Plot No. 266 Sector-6 IMT Manesar, KIT Gurgaon, Haryana M/s SD Bio Standard Diagnostics Pvt. Ltd., 18 SD HBsAG ELISA 3.0 KIT Plot No. 266 Sector-6 IMT Manesar, Gurgaon, Haryana M/s Transasia Biomedicals Ltd, 19 ErbaLisa Pico HBsAg B/11,OIDC,Ringanwada,Nani Daman396201 M/s .Qualpro Diagnostics,plot 20 Qualisa HBs Ag No.88/89,Phase II-C,Verna Industrial Estate,Verna,Goa

ELISA

ELISA

ELISA

Imported Kits
S.NO. NAME OF KIT NAME OF MANUFACTURER
MIS OMEGA DIAGNOSTICS LIMITED U.K. MIS GENERAL BIOLOGICALS CORP. TAIWAN MIS ROCHE DIAGNOSTICS GMBH WERK PENZBERG, GERMANY MIS GREEN CROSS LIFE SCIENCE CORP. (GCLS) KOREA MIS BIOMERIEUX B.V.BOSEIND THE NETHERLAND MIS STANDARD DIAGNOSTICS KOREA MIS BIO-RAD LABORATORIES, STEENVOORDE FRANCE MIS ORTHO CLINICAL DIAGNOSTICS USA MIS ORTHO CLINICAL DIAG. U.K.

CATEGORY
ELISA ELISA ELISA ELISA ELISA ELISA ELISA ELISA

1 PATHOZYME HBsAg
2 HBsAg ELISA TEST KIT (SURASE B-96, TMB)

3 COBASCORE HBsAgEIA
GENEDIA HBsAg ELISA 3.0 TEST KIT HEPANOSTIKA HBsAg 5 UNIFORM II HBsAg ELISA TEST KIT 6 (SD HBsAg 3.0) 4

7 MONOLISA AgHBs PLUS

ORTHO ANTIBODY TO 8 HBsAg ELISA TEST SYSTEM 3 HBsAg REAGENT PACK 9 WITH CALIBRATOR & CONTROL

ELISA ELISA ELISA ELISA CONFIRMATORY CONFIRMATORY CONFIRMATORY CONFIRMATORY PCR

10 BIOELISA HBsAg TEST KIT MIS BIOKIT SA SPAIN

11 HBsAg EIA PLUS

12 HBsAg ONE STEP HEPANOSTICKA HBsAg 13 UNIFORM II CONFIRMATORY MONOLISA HBsAg 14 CONFIRMATION HBsAg ELISA 3.0 15 CONFIRMA TIORY HBsAg CONFIRMATORY 16 ASSAY AMPLICOR HBV MONITOR 17 KIT

MIS ANI LAB SYSTEMS OY FINLAND MIS EQUIPAR S.R.L. ITALY ELISA MIS BIOMERIEUX B.V.BOSEIND THE NETHERLAND MIS BIO-RAD LABORATORIES, STEENVOORDE FRANCE MIS ORTHO CLINICAL DIAGNOSTICS USA MIS ORTHO CLINICAL DIAG. U.K. MIS ROCHE MOLECULAR SYSTEMS INC. USA

18 IMx HBsAg (V.2) INC. USA MIS ABBOTT GMBH & CO. GERMANY

19 AxSYM HBsAg (V.2)

AxSYMHBsAg CONFIRMATORY KIT ARCHITECT HBsAg REAGENT PACK WITH 21 CALIBRATORS & CONTROLS ARCHITECT HBsAg 22 CONFIRMATORY VI REAGENT PACK PRISMHBsAg ASSAY KIT 23 WITH HBsAg WASH KIT 20 24 VIDAS HBsAg

MIS ABBOTT GMBH & CO. GERMANY MIS ABBOTT GMBH & CO. GERMANY

WITH AxSYM EQUIPMENT WITH AxSYM EQUIPMENT WITH AxSYM EQUIPMENT WITH ARCHITECT EQUIPMENT WITH ARCHITECT EQUIPMENT WITH ARCHITECT EQUIPMENT WITHVIDAS EQUIPMENT RAPID RAPID ELISA PCR PCR PCR ELISA ELISA ELISA

MIS ABBOTT GMBH & CO. GERMANY

MIS ABBOTT GMBH & CO. GERMANY MIS ABBOTT GMBH & CO. GERMANY MIS BIOMERIEUX SA FRANCE MIS ACON BIOTECH (HANGZHOU) CO. LTD. CHINA

25 HBsAg RAPID TEST KIT

26 IMMUNOCOMB II HBsAg90 MIS ORGENICS LTD. ISRAEL

27 MONOCLONAL)
28

HBsAgEIA (AUSZYME COBAS AMPLICOR HBV MONITOR KIT COBAS AMPLISCREEN HBVKIT

MIS. ABBOTT LABORATORIES, USA MIS. ROCHE MOLECULAR SYSTEMS, USA -DO-DOMIS. DIASORIN S.R.L., ITALY

29

30 COBAS TAQMAN HBVKIT

31 MAK-4)
32

HBsAg ELISA KIT (ETI-

HBsAg ELISA KIT MIS. BIOKIT SA SPAIN (BIOELISA HBsAg COLOR) MIS. ZHONGSHAN BIOTECH CO. LTD., CHINA

33 HBsAg ELISA KIT

MONOLISA HBsAg CONFIRMATION 35 VIDAS HBsAg ULTRA VIDAS HBsAg ULTRA 36 CONFIRMATION HBsAGRAPID 37 DIAGNOSTIC KIT 34 1. VERSANT HBV DNA 3.0 ASSAY (BDNA) 2.ADVIA CENTAUR 38 HBSAG 3.ADVIA CENTAUR HBSAG CONFIRMATORY

MIS. BIORAD LABORATORIES, FRANCE CONFIRMATORY MIS. BIOMERIEUX S.A., FRANCE -DOMIS IND DIAGNOSTIC INC., 1629 FOSTERS WAY,DELTA,BC,CANADA MIS SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS,333 CONVEY ST., EAST WALPOLE, MA 02032-1597, USA. (INITIALLY THE NAME WAS MIS BAYER HEALTHACARE LLC, 333 CONVEY ST., EAST WALPOLE, MA 020321597, USA) ELISA CONFIRMATORY RAPID

PCR

39 Kit
40

1 LC/RGffM/GEL- HBV PCR 1. HbsAg One step ELISA kit

Mis. Artus GmbH, Hamburg, Germany

PCR

Mis. MBS SRL Medical Biological Services (Italy) via Divittorio 307/5, Serto S giovani ELISA (Milano)

41

1. Enzygnost HBsAg 5.0Supplementary Reagents. 2. HBsAg Confirmatory Test. 2. HbsAg Rapid Diagnostic Kit 1. Bioline HbsAg (HbsAg Rapid Test Kit) 2. Bioline Anti HbsAg (HbsAg Rapid Test Kit), 3. Bioline HbeAg /HbsAg Rapid Test Kit (HbeAg/HbsAg Rapid Test Kit)) 4. SD HbsAg Elisa 3.0 (HbsAg ELISA Kit) 5. SD Anti-HBs Elisa 3.0 (anti HBs Elisa Kit)

Mis Dade Behring Marburg GmBh, 35041, Marburg, P.O. Box 1149,35001, Marburg, ELISA Germany.

42

Mis. IND Diagnostics Inc, Delta, Canada

RAPID

43

Mis. Standard Diag Inc, 156-68 Hangal, Giheung-eup, KyonggiDo, Korea

RAPID

1. Rapid HBsAg Test Kit, 44 Elisa HBsAg Test Kit, 1. HBV Real Type PCR 2. HBV Real Quant PCR

Mis. Intec Product Inc, 332 Xinguang Road, Xinyung indo Area, Haicang, Xiamen, 361022, P.R. China Mis. General Biological Corporation, #6, Innovation First Road, Science Based, Industrial Park, Taiwan Mis. Adaltis Italia SpA, Via Cristoni 12-40053 Casalocchio di Reno Bologna, Italy Mis. Intec Products Inc. 332, Xinguang Road, Xinyang Area, Haicang Xiamen, 361022 (China Mis. Ani lab System Oy, Tiilitie 3 Fi-01720, Vantaa, Finland Mis. Biomerieux Brasil SA, 491, Taqura-J acarepagua, Rio-djanerio, Brazil

RAPID/ELISA

45

PCR

1. EIAgen HbsAg 46 Kit 1. ELISA HbsAg Kit 4. Rapid HbsAg Kit

EIA

47

RAPID/ELISA

48 1. HbsAg ELISA 1. Vikia HbsAg Kit.

ELISA

49

ELISA

1. HbsAg Serum/Plasma 50 Rapid test strip & cassette form.

Mis. Guangzhou window Biotech Co. Limited, window scientific Parks south china university of Technology, Guangzhou PER. China

RAPID

51

1. Architech HBsAgl Ab Reagent Kit, Calibrators, Controls and Manual Diluent. 2. Architech HBsAg Confirmatory V.1 Reagent Kit, Calibrators & Controls.

Mis. Abbott Ireland Diag. Div, Finisklin Business Park, Sligo, Ireland

ELISA

1. Immulite 1000 HBsAg Kit. 2. Immulite 1000 HBsAg 52 confirmatory Kit. 3. Immulite 2000 HBsAg Elisa Kit. (Total three Kits) 1. Abbott real time HBV calibrator kit. Abbott real time HBV control kit Abbott real time HBV amplification reagent kit

Mis Siemens Medical Solutions Diagnostics, 5210, Pacific Concourse Drive, Las Angeles Ca, 90045-6900, USA

ELISA

2. Mis. Abbott Molecular Inc, 1300 E, Toufy avenue, Des Plaines IL 3. 60018, USA

53

PCR

HbsAg ELISA test 54 kit

Mis. Zhongshan Biotech Co. Limited, sheng wugu Road, Zhongshang Torch, Hi-Tech Development Zone, Zhongshan City, Guangdong Province, PER. China Mis. Inverness Medical Japan Co. Limited, Japan. (Manufacturing premises: Abbott Japan co. Limited, Matsudo Plant-2, 278 matsuhidai, Matsudo-shi, chiba270-2214, Japan)

ELISA

I.HbsAg IVD

55 assay kit

ASSAY

List of HCV Diagnostic Kits Approved for Blood Bank use

INDIAN MANUFACTURERS
S.NO. NAME OF KIT 1 HEP-CHEX-C 2 HCV MICROLISA 3 INNOV A HCV ELISA 4 SIGNALHCV 5 HCVCOMB NAME OF MANUFACTURER MIS XCYTON DIAGNOSTICS LTD. BANGALORE MIS J. MITRA & CO. LTD. NEW DELHI MIS SPAN DIAGNOSTICS LTD. SURAT MIS SPAN DIAGNOSTICS LTD. SURAT MIS J. MITRA & CO. LTD. NEW DELHI CATEGORY ELISA ELISA ELISA RAPID RAPID RAPID ELISA RAPID ELISA RAPID RAPID RAPID ELISA ELISA RAPID ELISA RAPID

6 FLA VICHECK HCV RAPID MIS. QUALPRO DIAGNOSTIC, GOA 7 HCVELISA (QUALlS A HCV) MIS . . QUALPRO DIAGNOSTIC, GOA Mis APEX DIAGNOSTICS,MUMBAI-I Mis ROCHE DIAGNOSTICS INDIA PVT.LTD.,MUMBAI Mis IBEEJA Y TRADE LINKS,MUMBAI MIS J. MITRA & CO. LTD. NEW DELHI Mis. J. MITRA & CO. PVT. LTD, NEW DELHI -DoMis Transasia Biomedicals Ltd., Daman M/s Bhat Bio-Tech India Pvt. Ltd., Bangalore M/s TRANSASIA BIOMEDICAL LTD., DAMAN M/s SD Bio Standard Diagnostics Pvt. Ltd., Plot No. 266 Sector-6 IMT Manesar, Gurgaon, Haryana M/s SD Bio Standard Diagnostics Pvt. Ltd., Plot No. 266 Sector-6 IMT Manesar, Gurgaon, Haryana

8 HCV Cassette 9 ELECSYS Anti HCV 10 HCV Cassette 11 DIAGNOS HCV BI DOT 12 HCVTRI-DOT 13 HCV CLIA 14 Erba Lisa Hepatitis C Elisa Test Kit

15 Hepa Scan HCV Card Test

16 Erba Sure HCV Gen 3 17 SD Bioline HCV Rapid Kit

18 SD HCV Elisa 3.0 Kit

ELISA

IMPORTED KITS
S.NO. NAME OF KIT 1 HCVEIA 3.0 MUREX ANTI - HCV (VERSION 4) 2 VK47/48 HCV ELISA TEST KIT (SP-NANBASE 3 C-963.0) NAME OF MANUFACTURER MIS ABBOTT GMBH & CO. GERMANY MIS MUREX BIOTECH S.A.(PTY) LTD. SOUTH AFRICA CATEGORY ELISA ELISA

MIS GENERAL BIOLOGICALS CORP. TAIWAN

ELISA

COBASCORE 4 ANTI HCV EIA II 5 LGHCD3.0 6 LG HCD 3.0 PLUS GENEDIAHCV ELISA 3.0 TEST 7 KIT

MIS ROCHE DIAGNOSTICS GMBH WERK PENZBERG, GERMANY MIS LG CHEMICAL LTD. KOREA MIS LG CHEMICAL LTD. KOREA MIS GREEN CROSS LIFE SCIENCE CORP. (GCLS) KOREA MIS BEIJING UNITED BIOMEDICAL CO.LTD (BUB) CHINA

ELISA ELISA ELISA ELISA

8 UBI HCV EIA 4.0 HCV ELISA TEST KIT (SDHCV 9 ELISA 3.0) MONOLISA ANTI10 HCVPLUS HCV ELISA KIT 11 (DETECT HCV V.3) ORTHO HCV 3.0 ELISA TEST 12 SYSTEM WITH ENHANCED SAVe ORTHOANTI BODY TOHCV CORE ANTIGEN 13 ELISA TEST SYSTEM ANTI-HCV ANTIBODY ELISA 14 KIT ANTI-HCV REAGENT PACK WITH 15 CALIBRATOR & CONTROL BIOELISA HCV 16 TEST KIT 17 HCV AbELISA CHIRON RIBA HCV STRIP 18 IMMUNOBLOT ASSAY (SIA) 19 LG HCD CONFIRM

ELISA

MIS STANDARD DIAGNOSTICS KOREA MIS BIO-RAD LABORATORIES, STEENVOORDE FRANCE

ELISA

ELISA

MIS ADALTIS INC CANADA

ELISA

MIS ORTHO CLINICAL DIAGNOSTICS USA

ELISA

MIS ORTHO CLINICAL DIAGNOSTICS USA

ELISA

MIS ZHONGSHAN BIO-TECH CO. LTD. CHINA

ELISA

MIS ORTHO CLINICAL DIAG. U.K.

ELISA

MIS BIOKIT S.A. SPAIN MIS EQUIPAR S.R.L. ITALY

ELISA ELISA

MIS CHI RON CORPORATION USA

ELISA

MIS LG CHEMICAL LTD. KOREA

CONFIRMATORY

20 HCVBLOT3.0 ORTHO ANTIBODY TO HCVCORE 21 ANTIGEN ELISA CONFIRMATORY TEST AMPLICOR HCV 22 MONITOR KIT AMPLICOR HCV 23 KIT COBAS AMPLICOR 24 HCVKIT COBAS AMPLICOR HCVMONITOR 25 KIT COBAS AMPLISCREEN 26 HCVKIT IMx HCV VERSION 27 3.0 AxSYMHCV 28 VERSION 3.0 ARCHITECT ANTI HCVREAGENT PACK WITH 29 CALIBRATOR AND CONTROL PRISMHCV ASSAY KIT WITH 30 HCV WASH KIT COBAS TAQMAN 31 HCVKIT ORTHO ANTIBODY TO HCVCORE 32 ANTIGEN ELISA TEST SYSTEM HEPANOSTIKA 33 HCV ULTRA KIT

MIS GENE LABS DIAGNOSTIC PTE LTD. CONFIRMATORY SINGAPORE

MIS ORTHO CLINICAL DIAGNOSTICS USA

CONFIRMATORY

MIS ROCHE MOLECULAR SYSTEMS INC. USA

PCR

MIS ROCHE MOLECULAR SYSTEMS INC. PCR USA MIS ROCHE MOLECULAR SYSTEMS INC. USA PCR

MIS ROCHE MOLECULAR SYSTEMS INC. PCR USA

MIS ROCHE MOLECULAR SYSTEMS INC. PCR USA WITHIMx EQUIPMENT WITH AxSYM EQUIPMENT

MIS ABBOTT GMBH & CO. GERMANY

MIS ABBOTT GMBH & CO. GERMANY

MIS ABBOTT GMBH & CO. GERMANY

WITH ARCHITECT EQUIPMENT

MIS ABBOTT GMBH & CO. GERMANY

WITH PRISM EQUIPMENT

MIS. ROCHE MOLECULAR SYSTEMS INC, USA

PCR

MIS. ORTHO CLINICAL DIAGNOSTIC INC,USA

ELISA

MIS. BEIJING UNITED BIOMEDICAL CO., CHINA ELISA

HCV Cassette Rapid 34 Diagnostic Kit

MIS IND DIAGNOSTIC Inc., 1629 Fosters Way,Delta,BC,CAN ADA

RAPID

1.Versant HeV RNA 3.0 Assay (bDNA) 2.Versant ncv RNA Qualitative Assay 35 3. Versant HeV RNA Genotvpe Assav (Lioa) 4.Advia Centr HCV

Mis Siemens Medical Solutions Diagnostics,333 Convey St., East Walpole, MA 02032-1597, USA. (Initially the name was Mis BayerHealthacare LLC, 333 Convey St., East Walpole, MA 02032-1597, USA)

PCR

2. Anti HCV -EIA36 AVICENNA 2.HCV LC/TM/RG/GEL37 PCR Kit l. HCV Ab 38 ELISA Kit l. HCV Cassette Rapid Diagnostics 39 Kit

Mis Avicenna Medical Centre, 10/5, Ul, Stakhanovtsav, City of Pitersburg, Russia.

EIA

Mis. Artus GmbH, Hamburg, Mis. MBS SRL Medical Biological Services (Italy) via Divittorio 307/5, Serto S giovani (Milano) Mis. IND Diagnostics Inc, Delta, Canada Mis. Beijing Geneses Biotech Inc, Baijing Daxing Industry development Zone, Keyuan Road, 18, Beijing, China -102600

PCR

ELISA

RAPID

1. HCV Rapid 40 Card Kit

RAPID

1. Bioline HCV (HCV Rapid Test Kit) 41 2. SD HCV Elisa 3.0 (HCV Elisa Test Kit) 1. Rapid HCV Test Kit, 42 2. Elisa HCV Test Kit, l. EIAgen HCV 43 Ab Kit 1. ELISAHCV Kit 44 2. RapidHCV Kit.

Mis. Standard Diag Inc, 156-68 Hangal, Giheung-eup, Kyonggi-Do, Korea

RAPIDIELISA

Mis. Intec Product Inc, 332 Xinguang Road, Xinyung indo Area, Haicang, Xiamen, 361022, P.R. China Mis. Adaltis Italia SpA, Via Cristoni 12-40053 Casalocchio di Reno Bologna, Italy Mis. Intec Products Inc. 332, Xinguang Road, Xinyang Area, Haicang Xiamen, 361022 (China

RAPIDIELISA

EIA

RAPIDIELISA

l. HCV Serum/Plasma 45 rapid striplcassette form

Mis. Guangzhou window Biotech CO. Limited, window scientific Parks south china university of Technology, Guangzhou PER. China

RAPID

l. Abbott real time HCV calibrator kit, 2. Abbott real time HCV control kit 3. Abbott real Mis. Abbott Molecular Inc, 1300 E, time HCV Toufy avenue, Des Plaines IL 60018, 46 amplification USA reagent kit. 4. Abbott real time HCV amplification reagent kit

PCR