LIST OF CRITICAL DIAGNOSTIC KITS, BLOOD PRODUCTS,

AND MEDICAL DEVICES REGISTERED IN INDIA ALONG WITH

THEIR MANUFACTURING SITE AND INDIAN AUTHORIZED AGENTS
FOR IMPORT TILL DECEMBER, 2003

S.NO.

NAME OF AUTHORISED AGENT

NAME OF MANUFACTURER

PRODUCTS

M/S QUALIGENS FINE CHEMICALS DIV. OF GLAXO SMITHKLINE PHARMACEUTICALS LTD.

MUMBAI

M/S OMEGA DIAGNOSTICS LIMITED, U.K.

1. PATHOZYME HBsAg (ELISA)

M/S ABBOTT HEALTHCARE PVT. LTD. MUMBAI

M/S DAINABOT CO. LTD.

JAPAN

1. DETERMINE HIV ½ IVD ASSAY

2. DETERMINE HBsAg IVD ASSAY

M/S ABOTT HEALTHCARE PVT. LTD.

MUMBAI

M/S MUREX BIOTECH LTD.

U.K.

1. MUREX HIV-1.2.0 (GE94/95)

2. MUREX HIV-2 (GE 22)

3. MUREX HIV Ag/Ab COMBINATION (GE 41/42)

M/s ABOTT HEALTHCARE PVT. LTD.

MUMBAI

M/S ABBOTT GMBH & CO.

GERMANY

1. HIV-1/HIV-2 GO EIA

2. HCV EIA 3.0

3. IMx HBsAg (V.2)

4. IMx HIV-1/HIV-2 III PLUS

5. AxSYM HIV ½

6. AxSYM HBsAg (V.2)

7. IMx HCV VERSION 3.0

8. AxSYM HCV VERSION 3.0

9. AxSYM HIV 1 / 2 GO REAGENT PACK WITH CONTROLS

10. AxSYM HIV Ag/Ab COMBO REAGENT PACK WITH CONTROLS

11. AxSYM HBsAg CONFIRMATORY KIT

12. ARCHITECT HBsAg REAGENT PACK WITH CALIBRATORS & CONTROLS

13. ARCHITECT HBsAg CONFIRMATORY VI REAGENT PACK

14. ARCHITECT ANTI HCV REAGENT PACK WITH CALIBRATOR AND CONTROL

15. PRISM HIV O PLUS ASSAY KIT WITH HIV O PLUS WASH KIT

16. PRISM HBsAg ASSAY KIT WITH HBsAg WASH KIT

17. PRISM HCV ASSAY KIT WITH HCV WASH KIT

M/S ABBOTT HELATHCARE PVT. LTD.

MUMBAI

M/S MUREX BIOTECH S.A.(PTY) LTD.

SOUTH AFRICA

1. MUREX ANTI-HCV (VERSION 4) VK 47/48

M/S RAPID DIAGNOSTICS PVT. LTD.

DELHI

M/S ACON BIOTECH (HANGZHOU) CO. LTD.

CHINA

1. HIV ½ RAPID TEST KIT

2. HBsAg RAPID TEST KIT

3. HCV RAPID TEST KIT

M/S AMAR IMMUNODIAGNOSTICS

HYDERABAD

M/S GENERAL BIOLOGICALS CORP. TAIWAN

1. HIV ½ ELISA TEST KIT (HIVASE ½)

2. HCV ELISA TEST KIT (SP-NANBASE C-96 3.0)

3. HBsAg ELISA TEST KIT (SURASE B-96, TMB)

M/S ROCHE DIAGNOSTICS INDIA PVT. LTD.

NEW DELHI

M/S ROCHE MOLECULAR SYSTEMS INC.

USA

1. AMPLICOR HCV MONITOR KIT

2. AMPLICOR HBV MONITOR KIT

3. AMPLICOR HIV-I MONITOR KIT

4. AMPLICOR HIV-I KIT

5. AMPLICOR HCV KIT

6. COBAS AMPLICOR HCV KIT

7. COBAS AMPLICOR HIV-I MONITOR KIT

8. COBAS AMPLICOR HCV MONITOR KIT

9. COBAS AMPLISCREEN HCV KIT

10.COBAS AMPLISCREEN HIV-I KIT

M/S ROCHE DIAGNOSTICS INDIA PVT. LTD., NEW DELHI

M/S ROCHE DIAGNOSTICS GMBH WERK PENZBERG, GERMANY

1. COBAS CORE HBsAg EIA

2. COBAS CORE HIV COMBI.

3. COBAS CORE ANTI HCV EIA II

10.

M/S LG CHEMICAL INDIA PVT. LTD.

NEW DELHI

M/S LG CHEMICAL LTD.

KOREA

1. LG HCD 3.0

2. LG HCD 3.0 PLUS

3. LG HCD CONFIRM

11.

M/S RUCHI CORPORATION

MUMBAI

M/S GREEN CROSS LIFE SCIENCE CORP. (GCLS)

KOREA

1. GENEDIA HIV ½ ELISA 3.0
    TEST KIT
2. GENEDIA HCV ELISA 3.0 TEST
    KIT
3. GENEDIA HBsAg ELISA 3.0
    TEST KIT

4. GENEDIA HIV Ag/Ab ELISA

12.

M/S BIOMERIEUX INDIA PVT. LTD.

NEW DELHI

M/S BIOMERIEUX B.V.BOSEIND

THE NETHERLAND

1. HEPANOSTIKA HbsAg
UNIFORM II

2. HEPANOSTICKA HBsAg
UNIFORM II CONFIRMATORY

3. VIRONOSTIKA HIV UNIFORM II

Ag/Ab

4. VIRONOSTIKA HIV-I ANTIGEN

MICROELISA SYSTEM

13.

M/S BIOMERIEUX INDIA PVT. LTD.

NEW DELHI

M/S BEIJING UNITED BIOMEDICAL CO.LTD (BUB)

CHINA

1. UBI HCV EIA 4.0

14.

M/S BIOMERIEUX INDIA PVT. LTD.

NEW DELHI

M/S BIOMERIEUX S.A.

FRANCE

1. VIDAS HIV DUO

2. VIDAS HBsAg

3. VIDAS HIV p24 II

4. VIDAS HIV p24 CONFIRMATION

15.

M/S SUYOG DIAGNOSTIC PVT. LTD.

NEW DELHI

M/S GENE LABS DIAGNOSTIC PTE LTD.

SINGAPORE

1. HIV BLOT 2.2

2. HCV BLOT 3.0

16.

M/S SUYOG DIAGNOSTIC PVT. LTD.

NEW DELHI

M/S ORGENICS LTD.

ISRAEL

1. IMMUNOCOMB II HIV 1 & 2 BI-SPOT

2. IMMUNOCOMB II HBsAg 90

3. IMMUNOCOMB II HCV

4. IMMUNOCOMB II HIV 1 & 2 COMBIFIRM

17.

M/S MONOZYME INDIA LTD.

SECUNDRABAD

M/S STANDARD DIAGNOSTICS

KOREA

1. HIV 1 / 2 RAPID TEST KIT (BIOLINE HIV 1 / 2 3.0)

2. HCV RAPID TEST KIT (BIOLINE HCV)

3. HBsAg RAPID TEST KIT (BIOLINE HBsAg)

4. HIV 1 / 2 ELISA KIT (SD HIV 1 / 2 ELISA 3.0)

5. HCV ELISA TEST KIT (SD HCV ELISA 3.0)

6. HBsAg ELISA TEST KIT (SD HBsAg 3.0)

18.

M/S MOREPEN LABS LTD.

NEW DELHI

M/S DIAMED AG

SWITZERLAND

BLOOD GROUPING SERA

19.

M/S BIO-RED LABORATORIES (INDIA) PVT. LTD. HARYANA

M/S BIO-RED LABORATORIES, STEENVOORDE

FRANCE

1. GENSCREEN HIV 1 / 2 V.2

2. MONOLISA ANTI-HCV

PLUS

3. MONOLISA AgHBs PLUS

4. NEW LAV BLOT I

(CONFIRMATORY)

5. NEW LAV BLOT II

(CONFIRMATORY)

6. GENESCREEN PLUS HIV Ag-Ab

(ELISA)

20.

M/S BIO-RED LABS. (INDIA) PVT. LTD.

GURGAON

M/S BIO-RED LABORATORIES,

LESULIS

FRANCE

BLOOD GROUPING SERA

21.

M/S RAPID DIAGNOSTICS PVT. LTD.

DELHI

M/S ADALTIS INC.

CANADA

1. HIV 1 / 2 ELISA KIT

(DETECT HIV V.1)

2. HCV ELISA KIT (DETECT

HCV V.3)

22.

M/S VECTOR BIOTECH PVT. LTD.

GUJARAT

M/S INTEC PRODUCTS INC. (XIAMEN)

CHINA

1. RAPID HIV TEST

2. RAPID HCV TEST

3. RAPID HBsAg TEST

23.

M/S ARUN & CO.

MUMBAI

M/S EXCELL BIOTECH LTD.

U.K.

BLOOD GROUPING SERA

24.

M/S JOHNSON & JOHNSON LTD.

MUMBAI

M/S ORTHO CLINICAL DIAGNOSTICS

USA

1. ORTHO HCV 3.0 ELISA

TEST SYSTEM WITH

ENHANCED SAVe

2. ORTHO HIV-1/HIV-2 Ab

CAPTURE ELISA TEST

SYSTEM

3. ORTHO ANTIBODY TO

HBsAg ELISA TEST

SYSTEM 3

4. BLOOD GROUPING SERA

5. HBsAg ELISA 3.0

CONFIRMATORY

6. HBsAg ELISA 3.0

CONFIRMATORY

25.

M/S JOHNSON & JOHNSON LTD.

MUMBAI

M/S CSL LTD.

AUSTRALIA

BLOOD GROUPING SERA

26.

M/S SPECTRA PHARMA & HEALTH PRODUCTS

NEW DELHI

M/S ZHONGSHAN BIO-TECH CO. LTD.

CHINA

1. ANTI-HCV ANTIBODY ELISA KIT

2. HIV 1+2 ANTIBODY ELISA

KITS-add

27.

M/S JOHNSON & JOHNSON LTD.

MUMBAI

M/S ORTHO CLINICAL DIAG.

U.K.

1. ANTI-HIV 1 + 2 REAGENT PACK WITH CALIBRATOR & CONTROLS

2. ANTI-HCV REAGENT PACK WITH CALIBRATOR & CONTROL

3. HBsAg REAGENT PACK WITH CALIBRATOR & CONTROL

4. HBsAg CONFIRMATORY ASSAY

28.

M/S RANBAXY LABS LTD.

NEW DELHI

M/S SCOTTISH NATIONAL BLOOD TRANSFUSION SERVICE DIAGNOSTICS

SCOTLAND

BLOOD GROUPING SERA

29.

M/S INDOTECH INC. SUITE-14

KOLKATA

M/S CHEMBIO DIAGNOSTIC SYSTEMS INC.

USA

1. HIV1/2 SLAT PAK DIPSTICK

2. SUROCHECK HIV1/2

3. HIV ½ SLAT PAK

30.

M/S TRANSASIA BIO-MEDICALS LTD.

MUMBAI

M/S IMMUNETICS INC.

USA

HIV WESTERN BLOT TEST (QUALICODE HIV ½)

LIST OF BLOOD PRODUCTS

S.NO.

NAME OF AUTHORISED AGENT

NAME OF MANUFACTURER

PRODUCTS

M/S UNITED BIOTECH PVT. LTD.

NEW DELHI

M/S FINNISH RED CROSS, BLOOD TRANSFUSION SERVICE,

FINLAND

1. HUMAN ALBUMIN SOLUTION 20% (ALBUMIN SPR 200 mg/ml) EP/IP

2. HUMAN NORMAL IMMUNOGLOBULIN FOR INTRAVENOUS ADMINISTRATION LYOPHLISED (VENOGAMME) – 0.6g, 3g, 6g, 9g EP/I.P.

3. ANTI-HEAMOPHILIC FACTOR IX (BEMOFIL) – 500 I V &
1000 I V - EP

M/S LIFE MEDICARE AND BIOTECH PVT. LTD.

NEW DELHI

M/S SCOTTISH NATIONAL BLOOD TRANSFUSION SERVICE

U.K.

1. HUMAN ALBUMIN SOLUTION 20% (ALBA 20%) EP/IP

M/S BAXTER INDIA PVT. LTD.

NEW DELHI

M/S BAXTER HEALTHCARE CORPORATION

CALIFORNIA

1. FACTOR IX COMPLEX, HEAT TREATED (PROPLEX T) - USP

2. ANTIHEMOPHILIC FACTOR (HUMAN), (HEMOFIL M, MONOCLONAL PURIFIED) – USP

3. HUMAN ALBUMIN SOLN. 20%, 25% BUMIRATE IP/USP

M/S BAXTER INDIA PVT. LTD.

NEW DELHI

M/S BAXTER AG

AUSTRIA

1. HUMAN ANTI D (Rho) IMMUNOGLOBULIN INJ. (PARTOBULIN) - EP

2. HUMAN ALBUMIN SOLN. 5%, 20%, 25% EP/IP

3. HUMAN NORMAL IMMUNOGLOBULIN FOR I.V. USE (ENDOBULIN) S/D FREEZE DRIED VIRUS INTRAVATED – IP/EP

4. ANTI INHIBITOR CO-AGULENT COMPLEX, STREAM EREATED (FEIBR STIMU)

5. PURIFIED FREEZE – DRIED HUMAN COAGULATION FACTOR VIII VIRUS INACTIVATED (IMMUNATE) EP

6. TISSEEL KIT (FIBURISCRLAND)

KIT FREEZE DRIED

7. IMMUNE FACTOR IX

M/S MEDISPAN LTD.

CHENNAI

M/S OCTA PHARMA PHARMAZEUTIKA PRO

AUSTRIA

1. HUMAN ALBUMIN SOLUTION 5%, 20% (ALBUMED) – EP/IP

2. HUMAN NORMAL IMMUNOGLOBULIN (OCTAGAM) – 1g, 2.5g, 5.0g, 10g EP/IP

M/S CRITICARE PHARMA

MUMBAI

IMPORTER :- M/S CADILA HEALTHCARE LTD., AHEMDABAD.

M/S AVENTIS BEHRING GMBH

GERMANY

1. ANTI HAEMOPHILIC FACTOR VIII (BERIATE P) 250 IU, 500 IU, 1000 IU - EP

2. HUMAN NORMAL IMMUNOGLOBULIN INJECTION (I M) (BERIGLOBIN P) – IP/EP

3. ANTI HAEMOPHILIC FACTOR IX (BERININ P) 300 IU, 600 IU, 1200 IU - EP

4. HUMAN RABIES IMMUNOGLOBULIN
(BERIRAB P) - EP

5. HUMAN NORMAL IMMUNOGLOBULIN I.V. (GAMMA-VENIN P) – IP/EP

6. ANTI HAEMOPHILIC FACTOR VIII, LYOPHILISED (HAEMATE P) 250 IU, 500 IU, 1000 IU - EP

7. HEPATITIS
B-IMMUNOGLOBULIN P
BEHRING - EP

8. HUMAN SERUM ALBUMIN 20 % BEHRING LOW SALT - EP

9. KYBERNIN P 500 IU,
1000 IU - EP

10. HUMAN ANTI D (RHO) IMMUNOGLOBULIN
(MATERGAM P) - EP

11. HUMAN TETENUS IMMUNOGLOBULIN
(TETAGAM P) - EP

12. HUMAN INTRAVENOUS 7
S – IMMUNOGLOBULIN (VENIMMUN N) - EP

M/S ALPHA DRUGS

NEW DELHI

M/S BIO PRODUCTS LABORATORY

U.K

1. HUMAN SERUM ALBUMIN 20 %,
   4.5 % (ZENALB 20, 4.5) – IP/EP
2. NORMAL HUMAN
    IMMUNOGLOBULIN I.V. FREEZE
    DRIED POWDER 2.5 g, 5 g
    (VIGAM-S) – IP/EP
3. ANTI HEMOPHILIC FACTOR VIII
    250 IU AND 500 IU (DRIED
    FACTOR VIII FRACTION, TYPE
     8Y) – IP/EP.
4. ANTI HEMOPHILIC FACTOR IX
    250 IU, 500 IU & 1000 IU
    (REPLENINE – VF) – EP

5.HUMAN ANTI-D RHO
IMMUNOGLOBULIN I.M. BP

6. HUMAN TETANUS
IMMUNOGLOBULIN I.M. BP

7. HUMAN RABIES
IMMUNOGLOBULIN I.M. BP

M/S RUCHI CORP.

MUMBAI

M/S GREEN CROSS PHARMA DERIVATIVES CORP.,

KOREA

1. HUMAN NORMAL IMMUNOGLOBULIN I.V. (VERGLOB) – IP/EP

2. HEPATITIS B IMMUNE GLOBULIN HUMAN I.M.
(HEPABIG INJ.) – EP

M/S CLARIS LIFESCIENCES LTD.

AHMEDABAD

M/S ZLB BIO PLASMA AG,

SWITZERLAND

1. HUMAN NORMAL ALBUMIN 20 % (HUMIN 20) – EP/IP

2. HUMAN NORMAL IMMUNOGLOBULIN I.V. (SANDOGLOBULIN) 1gm, 3 gm, 6 gm, 12 gm – IP/EP

10.

M/S V.H.BHAGAT & CO.

MUMBAI

M/S SICHUAN YUANDA SHUYANG PHARMACEUTICAL CO. LTD.

CHINA

1.NORMAL HUMAN IMMUNOGLOBULIN I.V. – I.P.

2.HUMAN SERUM ALBUMIN I.P.

11.

M/S JOHNSON & JOHNSON LTD.

MUMBAI

M/S ORTHOCLINICAL DIAG. INC.,

USA

1. Rho (D) IMMUNE GLOBULIN (HUMAN) (RhoGAM ULTRAFILTERED) – USP

2. Rho (D) IMMUNE GLOBULIN (HUMAN) MICRhoGAM ULTRAFILTERED – USP

12.

M/S BHARAT SERUMS & VACCINES LTD.

MUMBAI

M/S HUMAN SERUMS PRODUCTION & MEDICINE MFG. CO. LTD.

HUNGARY

1. HUMAN NORMAL IMMUNOGLOBULIN I.V. (HUMAGLOBIN-CMV IgG INJ. FREEZE DRIED) - EP

2. HUMAN SERUM ALBUMIN 20 % - IP / EP

3. HUMAN NORMAL IMMUNOGLOBULIN (HUMAN GAMMA-GLOBULIN) 16%

4. HUMAN TETANUS IMMUNOGLOBULIN

13.

M/S SYNERGY DIAG. PVT. LTD.

THANE

M/S KAMADA LTD.

ISRAEL

1. ANTI-D (Rho) IMMUNOGLOBULIN I.M (Kam – Rho – D IM) – EP

14.

M/S BHARAT SERUMS & VACCINES LTD.

MUMBAI

M/S ALPHA THERAPEUTIC CORP.

USA

1. HUMAN SERUM ALBUMIN 5 %, 20 %, 25 % (ALBUTEIN) – IP/USP

15.

-DO-

M/s. GREEN CROSS PLASMA DERIVATIVES, KOREA

1. HUMAN TETANUS IMMUNOGLOBULIN (BULK)

2. HUMAN IMMUNE SERUM GLOBULIN POWDER (BULK)

16.

M/s. BHARAT SERUMS & VACCINES LTD., MUMBAI

M/S. HARDIS SPA., ITALY

1. HUMAN ANTI-D IMMUNOGLOBULIN

2. HUMAN TETANUS IMMUNOGLOBULIN

M/S. PAVIOUR PHARMACEUTICALS PVT. LTD., NEW DELHI

M/s. BIOTEST GMBH, GERMANY

1. HUMAN NORMAL IMMUNOGLOBULIN (PENTAGLOBIN)

2. HUMAN NORMAL IMMUNOGLOBULIN 2.V EP / IP (INTRAGLOBIN F)

3. HUMAN NORMAL IMMUNOGLOBULIN (INTRAGLOBIN CP) EP / IP

4. HUMAN ALBUMIN 20%, 5% IP / EP

5. ANTI HEMOPHILIC FACTOR VIII (FACTOR VIII SDH) EP

6. HUMAN HEPATITIS B IMMUNOGLOBULIN (HEPATECT CP) EP

7. ANTI-HUMAN T LYMPHOCYTE RABBIT GLOBULIN EP

18.

M/s. BHARAT SERUM AND VACCINE LTD., MUMBAI

M/s. HEMATALOG LTD., RUSSIA

1. IMMUNOGLOBULIN G ANTI RHESUS RHO (O) MONOCLONAL)

2. HUMAN (RHESOCLONE CONCENTRATED )

19.

M/s. HEMOPHILIA FEDERATION (INDIA), NEW DELHI

M/s. KEDRION SPA, ITALY

1. ANTI-HEMOPHILIC FACTOR VIII (EMOCLOT D.I.) E.P. 250IU, 500 IU, 1000IU

2. ANTI-HEMOPHILIC FACTOR IX (AIMAFIX D.I.) E.P. 200 IU & 500 IU

3. HUMAN NORMAL IMMUNOGLOBULIN I.V. (Ig VENA) EP / IP 1g, 2.5g, 5g, 10g

4. HUMAN SERUM ALBUMIN (UMAN ALBUMIN) IP/EP 20%

20.

M/s. SHREE KRISHNA KESHAV LABORATORIES LTD., AHMEDABAD

M/s. INSTITUTO GRIFILS SA, SPAIN

1. HUMAN ALBUMIN

2. HUMAN TETANUS IMMUNOGLOBULIN

21.

M/s. UNITED BIOTECH (P) LTD., NEW DELHI

M/s. HARDIS SPA S.A., ITALY

1. ANTI-D (RHO) HUMAN IMMUNOGLOBULIN I.M. 300mcg (IMMUNO RHO)

2 NORMAL HUMAN IMMUNOGLOBULIN 1g, 2.5g 10g I.V. (ISIVEN V.I.)

MEDICAL DEVICES

S. NO.	NAME OF THE FIRM	PRODUCT	AUTHORISED AGENT IN INDIA
1.	M/s NANJING ORGANON PHARMACEUTICAL COMPANY LIMITED, PUKOU HIGH-TECH DEVELOPMENT ZONE, P.O. BOX 3209-27, NANJING-210032, THE REPUBLIC OF CHINA Telephone no. + 86 25 8843034 Fax. No. + 86 25 8843157 E-mail : frans.van.birgelen@organon.com.cn	1. Intra Uterine Contraceptive Devices, Multiload Cu T 250 & CuT 375	M/S ORGANON INDIA LTD., Saturday Club Building, 7, Wood Street, Kolkata-700016, Tel. + 91(0) 33-2478301-05, + 91(0) 33-2471211-15, Fax. + 91(0) 33-2473750/3254, + 91(0) 33-2805069, + 91(0) 33-2817347, e-mail: hokolkata@organonindia.com
2.	M/s Becton Dickinson Medical (Singapore) Pte. Ltd., 30 Tuas Avenue 2 , Singapore 639461 Telephone no. 65-68601633 Fax. No. 65-68601593 website :www.bd.com	1. Disposable Hypodermic Needles 2. Disposable Hypodermic Syringes 3. Disposable Hypodermic Needles with Syringes	M/s Becton Dickinson India Pvt. Ltd., Gurgaon, Haryana. Tel. + 91(0) 33-2478301-05, + 91(124) 2383566, Fax. 91(124) 2383224/5/6, website: www.bd.com/india
3.	M/s Becton Dickinson S.A. Crta, Mequinenza s/n 22520 Fraga, (Heusca) Spain Telephone no. 34 974470900 Fax. No. 34 974470546 E. mail : website www.bd.com	1. Disposable Hypodermic Needles 2. Disposable Hypodermic Syringes 3. Auto Disable Syringes –Soloshot IX 4. Disposable Hypodermic Syringes with Needles	M/s Becton Dickinson India Pvt. Ltd., Gurgaon, Haryana. Tel. + 91(0) 33-2478301-05, + 91(124) 2383566, Fax. 91(124) 2383224/5/6, website: www.bd.com/india
4.	M/s The Female Health Company (UK) Plc. Unit 1, Sovereign Park, Coronation Road, London, NW10 7 QP, United Kingdom Phone No. 44 208 965 2813 Fax: 44 208 453 0324 e. mail: popemike@compuserve.com	1. Female Condom”	M/s Hindustan Latex Limited, Latex Bhawan, Poojappura P.O., Thireuvananthapuram-695 012
5.	M/s. SSN Medical Products SDN BHD, Malaysia	Latex Male Condom	M/S. Polar Pharma India Limited, Orissa
6.	M/s. Dispomed Witt OHG Am Spielacker, Germany	Sterile Hydodermic Single Use Syringes with Needles	M/S. HRJ Surgicals, Andheri (E), Mumbai