WHO list of Prequalified In Vitro Diagnostic Products
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| Product name | Product Code | WHO Product ID | Assay Format | Regulatory Version | Manufacturer name | Pathogen/Disease/Marker | Year prequalification |
|---|---|---|---|---|---|---|---|
| Abbott RealTime HCV |
|
0450-027-00 | NAT (nucleic acid testing) | JMHLW: Minister’s approval | Abbott Molecular Inc. | HCV | |
| Abbott RealTime High Risk HPV |
|
0455-180-00 | NAT (nucleic acid testing) | Directive 98/79/EC: Self-declared CE-mark, Annex III | Abbott GmbH - DUP | HPV | |
| Abbott RealTime HIV-1 (m2000sp) |
|
0145-027-00 | NAT (nucleic acid testing) | Directive 98/79/EC: Product design examination certificate, Annex IV.4 | Abbott Molecular Inc. | HIV | |
| Abbott RealTime HIV-1 (m24sp) |
|
0083-027-00 | NAT (nucleic acid testing) | Directive 98/79/EC: Product design examination certificate, Annex IV.4 | Abbott Molecular Inc. | HIV | |
| Abbott RealTime HIV-1 (manual) |
|
0146-027-00 | NAT (nucleic acid testing) | Directive 98/79/EC: Product design examination certificate, Annex IV.4 | Abbott Molecular Inc. | HIV | |
| Abbott RealTime HIV-1 Qualitative (m2000sp) |
|
0084-027-00 | NAT (nucleic acid testing) | Directive 98/79/EC: Product design examination certificate, Annex IV.4 | Abbott Molecular Inc. | HIV | |
| Abbott RealTime HIV-1 Qualitative (Manual) |
|
0151-027-00 | NAT (nucleic acid testing) | Directive 98/79/EC: Product design examination certificate, Annex IV.4 | Abbott Molecular Inc. | HIV | |
| ABON HIV 1/2/O Tri-Line Human Immunodeficiency Virus Rapid Test Device (Whole Blood/ Serum /Plasma) |
|
0141-051-00 | Immunochromatographic (lateral flow) | Rest-of-World | ABON Biopharm (Hangzhou) CO.,LTD | HIV | |
| Accupower HIV-1 Quantitative RT-PCR |
|
0454-140-00 | NAT (nucleic acid testing) | Rest-of-World | Bioneer Corporation | HIV | |
| AdvDx Malaria Pf Rapid Malaria Ag Detection Test |
|
0345-101-00 | Immunochromatographic (lateral flow) | Rest-of-World | Advy Chemical Pvt Ltd. | Malaria | |
| AiD anti-HIV 1+2 ELISA |
|
0006-005-00 | IA - Enzyme immunoassay EIA | Rest-of-World | Beijing Wantai Biological Pharmacy Enterprise Co., Ltd | HIV | |
| Alinity m HCV |
|
0461-027-00 | NAT (nucleic acid testing) | Directive 98/79/EC: Product design examination certificate, Annex IV.4 | Abbott Molecular Inc. | HCV | |
| Alinity m HIV-1 |
|
0640-027-00 | NAT (nucleic acid testing) | Directive 98/79/EC: Product design examination certificate, Annex IV.4 | Abbott Molecular Inc. | HIV | |
| Alinity m HR HPV |
|
09308-027-00 | NAT - PCR | Directive 98/79/EC: Self-declared CE-mark, Annex III | Abbott Molecular Inc. | HPV | |
| Aptima HIV-1 Quant Dx Assay |
|
0236-078-00 | NAT (nucleic acid testing) | Directive 98/79/EC: Product design examination certificate, Annex IV.4 | Hologic, Inc. | HIV | |
| Aquios CL flow cytometer |
|
0156-053-00 | Flow cytometry | Directive 98/79/EC: Product design examination certificate, Annex IV.4 | Beckman Coulter Life Sciences(Blue Ocean Biomedical LLC) | HIV | |
| ARCHITECT HCV Ag assay |
|
0374-130-00 | IA - Enzyme immunoassay EIA | Directive 98/79/EC: Product design examination certificate, Annex IV.4 | Denka Seiken Co., LTD, Kagamida Factory | HCV | |
| Bioline HBsAg WB (formerly SD BIOLINE HBsAg WB) |
|
0219-012-00 | Immunochromatographic (lateral flow) | Rest-of-World | Abbott Diagnostics Korea Inc. (Formerly Standard Diagnostics, Inc.) | HBV | |
| Bioline HCV (formerly SD BIOLINE HCV) |
|
0257-012-00 | Immunochromatographic (lateral flow) | Rest-of-World | Abbott Diagnostics Korea Inc. (Formerly Standard Diagnostics, Inc.) | HCV | |
| Bioline HIV/Syphilis Duo |
|
0179-012-00 | Immunochromatographic (lateral flow) | Rest-of-World | Abbott Diagnostics Korea Inc. (Formerly Standard Diagnostics, Inc.) | HIV, Syphilis | |
| Bioline HIV1/2 3.0 |
|
0027-012-00 | Immunochromatographic (lateral flow) | Rest-of-World | Abbott Diagnostics Korea Inc. (Formerly Standard Diagnostics, Inc.) | HIV | |
| Bioline Malaria Ag P.f |
|
0031-012-01 | Immunochromatographic (lateral flow) | Directive 98/79/EC: Self-declared CE-mark, Annex III | Abbott Diagnostics Korea Inc. (Formerly Standard Diagnostics, Inc.) | Malaria | |
| Bioline Malaria Ag P.f (HRP2/pLDH) |
|
0209-012-00 | Immunochromatographic (lateral flow) | Directive 98/79/EC: Self-declared CE-mark, Annex III | Abbott Diagnostics Korea Inc. (Formerly Standard Diagnostics, Inc.) | Malaria | |
| Bioline Malaria Ag P.f/P.f/P.v (formerly SD BIOLINE Malaria Ag P.f/P.f/P.v) |
|
0297-012-00 | Immunochromatographic (lateral flow) | Directive 98/79/EC: Self-declared CE-mark, Annex III | Abbott Diagnostics Korea Inc. (Formerly Standard Diagnostics, Inc.) | Malaria | |
| Bioline Malaria Ag P.f/P.v |
|
0125-012-00 | Immunochromatographic (lateral flow) | Directive 98/79/EC: Self-declared CE-mark, Annex III | Abbott Diagnostics Korea Inc. (Formerly Standard Diagnostics, Inc.) | Malaria | |
| Bioline Malaria Ag P.f/Pan |
|
0030-012-01 | Immunochromatographic (lateral flow) | Directive 98/79/EC: Self-declared CE-mark, Annex III | Abbott Diagnostics Korea Inc. (Formerly Standard Diagnostics, Inc.) | Malaria | |
| careHPV Test |
|
0085-028-00 | NAT (nucleic acid testing) | Rest-of-World | QIAGEN GmBH | HPV | |
| CheckNOW HIV SELF TEST |
|
0481-032-00 | Immunochromatographic (lateral flow) | Rest-of-World | Abbott Rapid Diagnostics Jena GmbH (former Alere Technologies GmbH) | HIV | |
| cobas 4800 HPV Test |
|
0466-046-00 | NAT (nucleic acid testing) | USFDA: Premarket Approval (PMA) | Roche Molecular Systems, Inc. | HPV | |
| COBAS AmpliPrep / COBAS TaqMan HIV-1 Test, version 2.0 (TaqMan 48) |
|
0126-046-00 | NAT (nucleic acid testing) | Directive 98/79/EC: Product design examination certificate, Annex IV.4 | Roche Molecular Systems, Inc. | HIV | |
| COBAS AmpliPrep / COBAS TaqMan HIV-1 Test, version 2.0 (TaqMan 96) |
|
0147-046-00 | NAT (nucleic acid testing) | Directive 98/79/EC: Product design examination certificate, Annex IV.4 | Roche Molecular Systems, Inc. | HIV | |
| COBAS AmpliPrep/COBAS TaqMan HIV-1 Qualitative Test, version 2.0 (TaqMan 48) |
|
0221-118-00 | NAT (nucleic acid testing) | Directive 98/79/EC: Product design examination certificate, Annex IV.4 | Roche Diagnostics GmbH | HIV | |
| COBAS AmpliPrep/COBAS TaqMan HIV-1 Qualitative Test, version 2.0 (TaqMan 96) |
|
0200-118-00 | NAT (nucleic acid testing) | Directive 98/79/EC: Product design examination certificate, Annex IV.4 | Roche Diagnostics GmbH | HIV | |
| cobas HCV (Quantitative nucleic acid test for use on the cobas 6800/8800 Systems) |
|
0465-118-00 | NAT (nucleic acid testing) | Directive 98/79/EC: Product design examination certificate, Annex IV.4 | Roche Diagnostics GmbH | HCV | |
| cobas HIV-1 Nucleic acid test for use on the cobas 4800 System |
|
0710-118-00 | NAT (nucleic acid testing) | Directive 98/79/EC: Product design examination certificate, Annex IV.4 | Roche Diagnostics GmbH | HIV | |
| cobas HIV-1 Quantitative nucleic acid test for use on the cobas 5800/6800/8800 Systems |
|
0365-046-00 | NAT (nucleic acid testing) | Directive 98/79/EC: Product design examination certificate, Annex IV.4 | Roche Molecular Systems, Inc. | HIV | |
| cobas HIV-1/HIV-2 Qualitative Nucleic acid test for use on the cobas 6800/8800 Systems and cobas HIV-1/HIV-2 Qualitative Nucleic acid test for use on the cobas 5800/6800/8800 Systems |
|
0528-046-00 | NAT (nucleic acid testing) | Directive 98/79/EC: Product design examination certificate, Annex IV.4 | Roche Molecular Systems, Inc. | HIV | |
| cobas HPV |
|
0468-046-00 | NAT (nucleic acid testing) | JMHLW: Minister’s approval | Roche Molecular Systems, Inc. | HPV | |
| CyFlow Counter System with CD4 easy count kit and CD4% easy count kit |
|
0350-081-00 | Flow cytometry | Directive 98/79/EC: Self-declared CE-mark, Annex III | Sysmex Partec GmbH | HIV | |
| Determine HBsAg 2 |
|
0451-013-00 | Immunochromatographic (lateral flow) | Rest-of-World | Abbott Diagnostics Medical Co., Ltd. (Formely "Alere Medical Co. Ltd.") | HBV | |
| Determine HIV Early Detect |
|
0243-013-00 | Immunochromatographic (lateral flow) | Rest-of-World | Abbott Diagnostics Medical Co., Ltd. (Formely "Alere Medical Co. Ltd.") | HIV | |
| Determine HIV-1/2 |
|
0033-013-00 | Immunochromatographic (lateral flow) | Rest-of-World | Abbott Diagnostics Medical Co., Ltd. (Formely "Alere Medical Co. Ltd.") | HIV | |
| Determine Syphilis TP |
|
0485-013-00 | Immunochromatographic (lateral flow) | Rest-of-World | Abbott Diagnostics Medical Co., Ltd. (Formely "Alere Medical Co. Ltd.") | Syphilis | |
| Diagnostic Kit for HIV(1+2) Antibody (Colloidal Gold) V2 |
|
0267-037-00 | Immunochromatographic (lateral flow) | Rest-of-World | Shanghai Kehua Bioengineering Co., Ltd. | HIV | |
| DPP HIV 1/2 Assay |
|
0053-006-00 | Immunochromatographic (lateral flow) | Rest-of-World | Chembio Diagnostic Systems, Inc. | HIV | |
| DPP HIV 1/2 Assay (oral fluid) |
|
0210-006-00 | Immunochromatographic (lateral flow) | Rest-of-World | Chembio Diagnostic Systems, Inc. | HIV | |
| DS-EIA-HBsAg-0,01, ENZYME IMMUNOASSAY FOR DETECTION AND CONFIRMATION OF HEPATITIS B SURFACE ANTIGEN |
|
0120-038-00 | IA - Enzyme immunoassay EIA | Directive 98/79/EC: Product design examination certificate, Annex IV.4 | RPC Diagnostic Systems, Ltd. | HBV | |
| DS-EIA-HIV-AGAB-SCREEN |
|
0106-038-00 | IA - Enzyme immunoassay EIA | Directive 98/79/EC: Product design examination certificate, Annex IV.4 | RPC Diagnostic Systems, Ltd. | HIV | |
| FalciVax - Rapid test for Malaria Pv/Pf |
|
0290-025-00 | Immunochromatographic (lateral flow) | Directive 98/79/EC: Self-declared CE-mark, Annex III | Zephyr Biomedicals – A Division of Tulip Diagnostics (P) Ltd. | Malaria | |
| First Response HCV Card Test |
|
0469-010-00 | Immunochromatographic (lateral flow) | Rest-of-World | Premier Medical Corporation Private Limited | HCV |
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