WHO list of Prequalified In Vitro Diagnostic Products
Displaying: 101 - 122 of 122
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| Product name | Product Code | WHO Product ID | Assay Format | Regulatory Version | Manufacturer name | Pathogen/Disease/Marker | Year prequalification |
|---|---|---|---|---|---|---|---|
| Rapid Test for Antibody to Human Immunodeficiency Virus (HIV) (Colloidal Gold Device) |
|
0005-005-00 | Immunochromatographic (lateral flow) | Rest-of-World | Beijing Wantai Biological Pharmacy Enterprise Co., Ltd (English version_for history purposes only) | HIV | |
| STANDARD G6PD Test |
|
0581-117-00 | Enzymatic | Directive 98/79/EC: Self-declared CE-mark, Annex III | SD Biosensor, Inc. | G6PD deficiency | |
| STANDARD Q HCV Ab Test |
|
0360-117-00 | Immunochromatographic (lateral flow) | Rest-of-World | SD Biosensor, Inc. | HCV | |
| STANDARD Q HIV 1/2 Ab 3-Line Test |
|
0383-117-00 | Immunochromatographic (lateral flow) | Rest-of-World | SD Biosensor, Inc. | HIV | |
| STANDARD Q HIV/Syphilis Combo Test |
|
0382-117-00 | Immunochromatographic (lateral flow) | Rest-of-World | SD Biosensor, Inc. | HIV, Syphilis | |
| STANDARD Q Malaria P.f Ag Test |
|
0346-117-00 | Immunochromatographic (lateral flow) | Directive 98/79/EC: Self-declared CE-mark, Annex III | SD Biosensor, Inc. | Malaria | |
| STANDARD Q Malaria P.f/P.v Ag Test |
|
0348-117-00 | Immunochromatographic (lateral flow) | Directive 98/79/EC: Self-declared CE-mark, Annex III | SD Biosensor, Inc. | Malaria | |
| STANDARD Q Malaria P.f/Pan Ag Test |
|
0347-117-00 | Immunochromatographic (lateral flow) | Directive 98/79/EC: Self-declared CE-mark, Annex III | SD Biosensor, Inc. | Malaria | |
| SURE CHECK HIV 1/2 Assay |
|
0054-006-00 | Immunochromatographic (lateral flow) | Rest-of-World | Chembio Diagnostic Systems, Inc. | HIV | |
| Surecheck HIV Self-Test |
|
0054-006-01 | Immunofiltration (flow through) | Rest-of-World | Chembio Diagnostic Systems, Inc. | HIV | |
| TrinScreen HIV |
|
0473-052-00 | Immunochromatographic (lateral flow) | Rest-of-World | Trinity Biotech Manufacturing Ltd | HIV | |
| Uni-Gold HIV |
|
0149-052-00 | Immunochromatographic (lateral flow) | Rest-of-World | Trinity Biotech Manufacturing Ltd | HIV | |
| VISITECT CD4 Advanced Disease |
|
0384-077-00 | Immunochromatographic (lateral flow) | Rest-of-World | AccuBio Ltd | HIV | |
| Wondfo HIV Self-Test |
|
0357-004-01 | Immunochromatographic (lateral flow) | Rest-of-World | Guangzhou Wondfo Biotech Co., Ltd | HIV | |
| Wondfo Malaria P.f (HRP2/pLDH) Test |
|
0651-004-00 | Immunochromatographic (lateral flow) | Rest-of-World | Guangzhou Wondfo Biotech Co., Ltd | Malaria | |
| Xpert HCV Viral Load with GeneXpert Dx, GeneXpert Infinity-48s, and GeneXpert Infinity-80 |
|
0260-070-00 | NAT (nucleic acid testing) | Directive 98/79/EC: Product design examination certificate, Annex IV.4 | Cepheid AB | HCV | |
| Xpert HCV VL Fingerstick |
|
0453-070-00 | NAT (nucleic acid testing) | Directive 98/79/EC: Product design examination certificate, Annex IV.4 | Cepheid AB | HCV | |
| Xpert HIV-1 Qual XC |
|
0652-070-00 | NAT (nucleic acid testing) | Directive 98/79/EC: Product design examination certificate, Annex IV.4 | Cepheid AB | HIV | |
| Xpert HIV-1 Viral Load XC |
|
0691-070-00 | NAT - qPCR | Directive 98/79/EC: Product design examination certificate, Annex IV.4 | Cepheid AB | HIV | |
| Xpert HPV |
|
0268-070-00 | NAT (nucleic acid testing) | Directive 98/79/EC: Product design examination certificate, Annex IV.4 | Cepheid AB | HPV | |
| Xpert MTB/RIF Ultra |
|
10295-070-00 | NAT (nucleic acid testing) | Rest-of-World | Cepheid AB | Mycobacterium tuberculosis complex (MTBC) | |
| Xpert MTB/XDR |
|
10308-070-00 | NAT - PCR | Directive 98/79/EC: Self-declared CE-mark, Annex III | Cepheid AB | Mycobacterium tuberculosis complex (MTBC) |
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