WHO list of Prequalified In Vitro Diagnostic Products
Displaying: 51 - 100 of 122
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| Product name | Product Code | WHO Product ID | Assay Format | Regulatory Version | Manufacturer name | Pathogen/Disease/Marker | Year prequalification |
|---|---|---|---|---|---|---|---|
| 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 | |
| First Response HIV 1-2.O Card test Version 2.0 |
|
0363-010-00 | Immunochromatographic (lateral flow) | Rest-of-World | Premier Medical Corporation Private Limited | HIV | |
| First Response HIV1+2/Syphilis Combo Card Test |
|
0364-010-00 | Immunochromatographic (lateral flow) | Rest-of-World | Premier Medical Corporation Private Limited | HIV, Syphilis | |
| First Response Malaria Ag. P.f. / P.v. Card Test |
|
0329-010-00 | Immunochromatographic (lateral flow) | Directive 98/79/EC: Self-declared CE-mark, Annex III | Premier Medical Corporation Private Limited | Malaria | |
| First Response Malaria Ag. pLDH/HRP2 Combo Card Test |
|
0285-010-00 | Immunochromatographic (lateral flow) | Rest-of-World | Premier Medical Corporation Private Limited | Malaria | |
| First Response Malaria Antigen P. falciparum (HRP2) Card Test |
|
0283-010-00 | Immunochromatographic (lateral flow) | Rest-of-World | Premier Medical Corporation Private Limited | Malaria | |
| First Response Syphilis Anti-TP Card Test |
|
0471-010-00 | Immunochromatographic (lateral flow) | Rest-of-World | Premier Medical Corporation Private Limited | Syphilis | |
| Geenius HIV 1/2 Confirmatory Assay with Geenius HIV1/2 Confirmatory Controls |
|
0181-031-00 | Immunochromatographic (lateral flow) | Directive 98/79/EC: Product design examination certificate, Annex IV.4 | Bio-Rad | HIV | |
| Genie Fast HIV 1/2 |
|
0153-031-00 | Immunochromatographic (lateral flow) | Directive 98/79/EC: Product design examination certificate, Annex IV.4 | Bio-Rad | HIV | |
| Genscreen ULTRA HIV Ag-Ab |
|
0096-031-00 | IA - Enzyme immunoassay EIA | Directive 98/79/EC: Product design examination certificate, Annex IV.4 | Bio-Rad | HIV | |
| HCV Hepatitis C Virus Rapid Test Device (Whole blood/Serum/Plasma) |
|
0387-051-00 | Immunochromatographic (lateral flow) | Rest-of-World | ABON Biopharm (Hangzhou) CO.,LTD | HCV | |
| HIV 1/2 STAT-PAK |
|
0007-006-00 | Immunochromatographic (lateral flow) | Rest-of-World | Chembio Diagnostic Systems, Inc. | HIV | |
| HIV SELF TEST BY URINE – Human Immunodeficiency Virus (HIV) type-I urine antibody diagnostic kit (colloidal gold) |
|
0544-005-00 | Immunochromatographic (lateral flow) | Rest-of-World | Beijing Wantai Biological Pharmacy Enterprise Co., Ltd (English version_for history purposes only) | HIV | |
| INNO-Lia HCV Score |
|
0202-073-00 | IA - Enzyme immunoassay EIA | Directive 98/79/EC: Product design examination certificate, Annex IV.4 | Fujirebio Europe NV | HCV | |
| INNO-Lia HIV I/II Score |
|
0203-073-00 | IA (immunoassay) | Directive 98/79/EC: Product design examination certificate, Annex IV.4 | Fujirebio Europe NV | HIV | |
| INNOTEST HCV Ab IV |
|
0201-073-00 | IA - Enzyme immunoassay EIA | Directive 98/79/EC: Product design examination certificate, Annex IV.4 | Fujirebio Europe NV | HCV | |
| Insti HIV Self Test |
|
0002-002-01 | Immunofiltration (flow through) | Rest-of-World | bioLytical Laboratories Inc. | HIV | |
| INSTI HIV-1/HIV-2 Antibody Test |
|
0002-002-00 | Immunofiltration (flow through) | Rest-of-World | bioLytical Laboratories Inc. | HIV | |
| m-PIMA HIV-1/2 Detect |
|
0226-032-00 | NAT (nucleic acid testing) | Directive 98/79/EC: Product design examination certificate, Annex IV.4 | Abbott Rapid Diagnostics Jena GmbH (former Alere Technologies GmbH) | HIV | |
| m-PIMA HIV-1/2 VL |
|
0359-032-00 | NAT (nucleic acid testing) | Rest-of-World | Abbott Rapid Diagnostics Jena GmbH (former Alere Technologies GmbH) | HIV | |
| MERISCREEN HIV 1-2 WB |
|
0464-074-00 | Immunochromatographic (lateral flow) | Directive 98/79/EC: Full quality assurance certificate, Annex IV.3 | Meril Diagnostics Pvt. Ltd. | HIV | |
| Monolisa HCV Ag-Ab ULTRA V2 |
|
0229-031-00 | IA - Enzyme immunoassay EIA | Directive 98/79/EC: Product design examination certificate, Annex IV.4 | Bio-Rad | HCV | |
| MP Diagnostics HIV Blot 2.2 |
|
0198-071-00 | IA - Immunoblot | Directive 98/79/EC: Product design examination certificate, Annex IV.4 | MP Biomedicals Asia Pacific Pte.Ltd. | HIV | |
| Murex HBsAg Version 3 with Murex HBsAg Confirmatory Version 3 |
|
0121-043-00 | IA - Enzyme immunoassay EIA | Directive 98/79/EC: Product design examination certificate, Annex IV.4 | DiaSorin S.p.A - UK Branch | HBV | |
| Murex HIV Ag/Ab Combination |
|
0144-043-00 | IA - Enzyme immunoassay EIA | Directive 98/79/EC: Product design examination certificate, Annex IV.4 | DiaSorin S.p.A - UK Branch | HIV | |
| Mylan HIV Self Test |
|
0320-090-00 | Immunochromatographic (lateral flow) | Rest-of-World | Atomo Diagnostics Ltd | HIV | |
| NxTek Eliminate Malaria Ag P.f (formely Alere Malaria Ag P.f) |
|
0349-012-00 | Immunochromatographic (lateral flow) | Directive 98/79/EC: Self-declared CE-mark, Annex III | Abbott Diagnostics Korea Inc. (Formerly Standard Diagnostics, Inc.) | Malaria | |
| ONE STEP Anti‐HIV (1&2) Test |
|
0372-017-00 | Immunochromatographic (lateral flow) | Rest-of-World | InTec Products, Inc. | HIV | |
| One Step HIV1/2 Whole Blood/Serum/Plasma Test |
|
0357-004-00 | Immunochromatographic (lateral flow) | Rest-of-World | Guangzhou Wondfo Biotech Co., Ltd | HIV | |
| ONE STEP Malaria (Pf) Test |
|
0626-017-00 | Immunochromatographic (lateral flow) | Rest-of-World | InTec Products, Inc. | Malaria | |
| ONE STEP Malaria (Pf/Pv) Tri-line Test |
|
0627-017-00 | Immunochromatographic (lateral flow) | Rest-of-World | InTec Products, Inc. | Malaria | |
| One Step test for Malaria Pf HRP-II Ag MERISCREEN Malaria Pf HRP-II Ag |
|
0470-074-00 | Immunochromatographic (lateral flow) | Rest-of-World | Meril Diagnostics Pvt. Ltd. | Malaria | |
| One Step test for Malaria Pf/Pan Ag MERISCREEN Malaria Pf/Pan Ag |
|
0330-074-00 | Immunochromatographic (lateral flow) | Rest-of-World | Meril Diagnostics Pvt. Ltd. | Malaria | |
| One Step test for Malaria Pf/Pv Ag MERISCREEN Malaria Pf/Pv Ag |
|
0294-074-00 | Immunochromatographic (lateral flow) | Rest-of-World | Meril Diagnostics Pvt. Ltd. | Malaria | |
| OraQuick HCV Rapid Antibody Test Kit |
|
0244-055-00 | Immunochromatographic (lateral flow) | Directive 98/79/EC: Full quality assurance certificate, Annex IV.3 | OraSure Technologies, Inc. | HCV | |
| OraQuick Hepatitis C Self-Test |
|
0244-055-01 | Immunochromatographic (lateral flow) | Rest-of-World | OraSure Technologies, Inc. | HCV | |
| OraQuick HIV 1/2 Rapid Antibody Test |
|
0159-055-00 | Immunochromatographic (lateral flow) | Directive 98/79/EC: Product design examination certificate, Annex IV.4 | OraSure Technologies, Inc. | HIV | |
| Oraquick HIV Self Test |
|
0159-055-01 | Immunochromatographic (lateral flow) | Rest-of-World | OraSure Technologies, Inc. | HIV | |
| Panbio HIV Verification Test (former name : Maxure HIV‐1/2) |
|
0480-032-00 | Immunochromatographic (lateral flow) | Rest-of-World | Abbott Rapid Diagnostics Jena GmbH (former Alere Technologies GmbH) | HIV | |
| Paracheck Pf - Rapid Test for P. Falciparum Malaria Device (Ver. 3) |
|
0321-024-00 | Immunochromatographic (lateral flow) | Directive 98/79/EC: Self-declared CE-mark, Annex III | Orchid Biomedical Systems – A Division of Tulip Diagnostics (P) Ltd | Malaria | |
| ParaHIT f Ver. 1.0 Rapid Test for P. falciparum Malaria Device |
|
0062-023-00 | Immunochromatographic (lateral flow) | Directive 98/79/EC: Self-declared CE-mark, Annex III | Arkray Healthcare Private Limited | Malaria | |
| parascreen - Rapid test for Malaria Pan/Pf |
|
0291-025-00 | Immunochromatographic (lateral flow) | Directive 98/79/EC: Self-declared CE-mark, Annex III | Zephyr Biomedicals – A Division of Tulip Diagnostics (P) Ltd. | Malaria | |
| Pima CD4 test |
|
0099-032-00 | Flow cytometry | Directive 98/79/EC: Product design examination certificate, Annex IV.4 | Abbott Rapid Diagnostics Jena GmbH (former Alere Technologies GmbH) | HIV | |
| Rapid Anti‐HCV Test |
|
0371-017-00 | Immunofiltration (flow through) | Rest-of-World | InTec Products, Inc. | HCV |
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