WHO list of prequalified in vitro diagnostic products
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1 : Rest of the world. Regulatory version applied to products not approved by stringent/mature NRAs or not regulated 2018 CD4 Muse Auto CD4/CD4% kit MCA100101, MCA500101, MCA1XK101 EMD Millipore Corporation Temecula, California 92590, USA 100 T/kit; 500 T/kit; 1000 T/kit 2018 HCV EIA INNOTEST HCV Ab IV 80068, Fujirebio Europe NV Ghent, Belgium 192T/kit; 2017 HBsAg RDT SD BIOLINE HBsAg WB 01FK10W 30T/kit 2017 HIV RDT Genie Fast HIV 1/ , 72347, Bio Rad Marne La Coquette, France 2017 Xpert HPV GXHPV CE 10 Cepheid AB Solna, Sweden 10T/kit 2017 Aptima HIV 1 Quant Dx Assay PRD (PRD 03002, PRD 03001), , PRD Hologic, Inc. San Diego, USA 100T/kit 2017 HIV RDT for selftesting OraQuick HIV Self Test 5X4 1000, 5X4 1001, 5X OraSure, Inc. Bethlehem, USA ; 2; 110T/kit 2017 Xpert HIV 1 Viral Load GXHIV VL CE 10 Cepheid AB Solna, Sweden 10T/kit 2017 HCV NAT Xpert HCV Viral Load GXHCV VL CE 10 Cepheid AB Solna, Sweden 10T/kit 2017 HIV Confirmatory Assay Geenius HIV 1/2 Confirmatory Assay with Geenius HIV1/2 Confirmatory Controls 2017 HCV RDT OraQuick HCV Rapid Antibody Test Kit , , Bio Rad Marnes La Coquette, France 20T/kit OraSure, Inc. Bethlehem, USA 100T/kit
2 : Rest of the world. Regulatory version applied to products not approved by stringent/mature NRAs or not regulated 2016 HIV RDT Diagnostic kit for HIV (1+2) antibody (colloidal gold) V2 R C 2, KH R 02, A GOLD 01 Shanghai Kehua Bioengineering Co., Ltd Shanghai, PR China 2016 HCV RDT SD BIOLINE HCV 02FK10 30T/kit 2016 HBsAg EIA bioelisa HBsAg , Biokit S.A. Llicà d`amunt, Spain 2016 HIV RDT First Response HIV Card Test I05FRC100, I05FRC60, I05FRC30, I05FRC05 Premier Medical Corporation Nani Daman, Daman, India and Sarigam, Gujarat, India 100T/kit; 60T/kit; 30T/kit; 5T/kit; 2016 HIV RDT Alere HIV Combo 7D2842, 7D2843, 7D2843SET Alere Medical Co. Ltd. Matsudo shi, Chiba ken, Japan 20T/kit; 100T/kit; 100T/kit 2016 HIV NAT Xpert HIV 1 Qual Assay GXHIV QA CE 10 Cepheid AB Solna, Sweden 10 cartridges/kit and instrument 2016 HIV NAT Alere q HIV 1/2 Detect , , Alere GmbH Jena, Germany 10 cartridges/kit and instrument; 50 cartridges/kit and instrument 2016 HIV RDT DPP HIV 1/2 Assay Chembio Diagnostic Systems Inc. Medford, NY, USA 20T/kit 2016 HIV RDT OraQuick HIV 1/2 Rapid Antibody Test 5x4 0010, 5x OraSure, Inc. Bethlehem, USA and Petchabun, Thailand 100T/kit; 500T/kit
3 : Rest of the world. Regulatory version applied to products not approved by stringent/mature NRAs or not regulated 2016 HBsAg EIA DS EIA HBsAg 0,01 В 1254, В 1252, В 1255, В 1256, В 231 RPC Diagnostics Systems Nizhniy Novgorod, Russia 192T/kit; ; 96T or 48T (if confirmation)/kit 200T/kit 2016 HIV Confirmatory Assay MP Diagnostics HIV Blot , MP Biomedicals Asia Pacific Pte.Ltd. Singapore, Singapore 18T/kit; 36T/kit 2016 HBsAg EIA Enzygnost HBsAg 6.0 and supplementary reagents kit for Enzygnost /TMB OPFM03, OPFM05, OPFM13(Q), OUVP17 Siemens Healthcare Diagnostics Products GmbH Marburg, Germany 960T/kit; 960T/kit (for higherthroughput) 2016 HIV EIA Enzygnost HIV Integral 4 and Supplementary reagents kit for Enzygnost /TMB OPKR03, OPKR05, OPKR07(Q), OUVP17 Siemens Healthcare Diagnostics Products GmbH Marburg, Germany 960T/kit; 960T/kit (for higherthroughput) 2016 HIV EIA AiD anti HIV 1+2 ELISA WI 4396, WI Beijing Wantai Biological Pharmacy Enterprise Co. Beijing, China 2016 HIV RDT Rapid Test for Antibody to Human Immunodeficiency Virus (HIV) (Colloidal Gold Device) WJ 1810, WJ 1810E, WJ 1850, WJ 1850E Beijing Wantai Biological Pharmacy Enterprise Co. Beijing, China 10T/kit w/accessories; 10T/kit; 2015 CD4 Aquios CL flow cytometer B30166, B39101 B39102, B25697, B25698, B23536, B23538, B23533, B23534, B23535, B25700, B23502 Beckman Coulter Life Sciences Miami, FL, USA (instrument site) and Hialeah, FL, USA (reagent site)
4 : Rest of the world. Regulatory version applied to products not approved by stringent/mature NRAs or not regulated 2015 HIV/Syp RDT Alere HIV/Syphilis Duo 06FK30, 06FK35 25T/kit 2015 Malaria RDT SD BIOLINE Malaria Ag P.f/P.v 05FK80, 05FK81, 05FK82, 05FK83, 05FK86, 05FK87 25X1T/kit 2015 Malaria RDT SD BIOLINE Malaria Ag P.f (HRP2/pLDH) 05FK90, 05FKFK93, 05FK91, 05FK092 25X1T/kit 2015 HCV EIA INNO LIA HCV Score Fujirebio Europe NV Zwijnaarde, Belgium 20T/kit 2015 HIV EIA DS EIA HIV AGAB SCREEN I 1654, I 1652, I 1656 RPC Diagnostics Systems Nizhniy Novgorod, Russia 96T/1 plate; 192T/2 plates; 480 T/5 plates 2015 HCV EIA Murex anti HCV (version 4.0) 7F51 01, 7F51 02 DiaSorin South Africa (Pty) Ltd. Kyalami, South Africa 96T/kit 2015 Malaria RDT CareStart Malaria HRP2/pLDH (Pf/PAN) COMBO RMRM 02571, RMRM (old product code G0131); Access Bio, Inc. Somerset NJ, USA ; 2015 Malaria RDT CareStart Malaria HRP2 (Pf) RMOM 02571, RMOM (old product code G0141); Access Bio, Inc. Somerset NJ, USA ; 2015 Malaria RDT CareStart Malaria HRP2/pLDH (Pf/Pv) COMBO RMVM 02571, RMVM (old product code G0161) Access Bio, Inc. Somerset NJ, USA
5 : Rest of the world. Regulatory version applied to products not approved by stringent/mature NRAs or not regulated 2015 Malaria RDT CareStart Malaria HRP2/pLDH (Pf) 2015 Malaria RDT CareStart Malaria pldh (PAN) RMPM 02571, RMPM (old product code G0181) RMNM 02571, RMNM (old product code G0111) Access Bio, Inc. Somerset NJ, USA Access Bio, Inc. Somerset NJ, USA 2015 HIV Confirmatory Assay INNO Lia HIV I/II Score Fujirebio Europe NV Ghent, Belgium 20T/kit 2015 HCV EIA Bioelisa HCV , Biokit S.A. Barcelona, Spain 2015 HIV EIA Murex HIV Ag/Ab Combination 7G79 09 (GE41, 96 wells) and 7G79 11 (GE42, 480 wells) DiaSorin S.p.A UK Branch Dartford, UK 2015 HIV EIA Bioelisa HIV 1+2 Ag/Ab , Biokit S.A. Barcelona, Spain 2015 Malaria RDT First Response Malaria Ag P. falciparum (HRP2) Card Test I13FRC25, I13FRC30 Premier Medical Corporation Nani Daman and Sarigam, India 30T/kit 2014 COBAS AmpliPrep/COBAS TaqMan HIV 1 Qualitative Test, version 2.0 (TaqMan 48) , , , , , , , Roche Molecular Systems, Inc. Branchburg, New Jersey, USA 48T/kit
6 : Rest of the world. Regulatory version applied to products not approved by stringent/mature NRAs or not regulated 2014 COBAS AmpliPrep/COBAS TaqMan HIV 1 Qualitative Test, version 2.0 (TaqMan 96) , , , , , , , Roche Diagnostics GmbH Mannheim, Germany 48T/kit 2014 HIV RDT SURE CHECK HIV 1/2 Assay HIV201 Chembio Diagnostic Systems Inc. Medford, NY, USA 25T/kit 2014 HBsAg EIA Murex HBsAg Version 3 with Murex HBsAg Confirmatory Version 3 9F80 01, 9F80 05, 2G27 01 DiaSorin S.p.A UK Branch Dartford, UK 2014 Malaria RDT ParaHIT f Ver. 1.0 Rapid Test for P.falciparum Malaria Device 55IC104 10, 55IC and, 55IC ARKRAY Healthcare Pvt. Ltd. Sachin (Surat), India 10T/kit; 2014 CD4 BD FACSPresto Near Patient CD4 Counter with BD CD4%CD4/Hb Cartridge and BD FACSPresto Cartridges Kit , , Becton, Dickinson and Company, BD Biosciences San Jose, California, USA Singapore, Singapore : instrument : catridge (100/box) and : pipette (100/box) 2014 HIV RDT ABON HIV 1/2/O Tri Line Human Immunodeficiency Virus Rapid Test Device IHI T402WG, IHI T0402WA ABON Biopharm (Hangzhou) Co. Ltd. Hangzhou, PR China 40T/kit 2013 HIV RDT VIKIA HIV 1/ biomérieux SA Marcy L Etoile, France 25T/kit
7 : Rest of the world. Regulatory version applied to products not approved by stringent/mature NRAs or not regulated 2013 HIV RDT INSTI HIV 1/HIV 2 Antibody Test , , , BioLytical Laboratories, Inc. Richmond, British Columbia, Canada 24T/kit; 24T/kit with support materials; 48T/kit; 48T/kit with support materials 2013 Malaria RDT SD BIOLINE Malaria Ag P.f/Pan SD BIOLINE Malaria Ag P.f/Pan (POCT) 05FK60, 05FK61, 05FK62, 05FK63, 05FK67 25x1T/kit; 1T/kit; 30T/kit 2013 Abbott RealTim e HIV 1 Qualitative (Manual) 4N66 90, 4N66 80, 6K12 24, 9K15 01, 4N66 01, 4N66 66 (optional) Abbott Molecular Inc. Des Plaines, IL, USA 4x24T pack 2013 Abbott RealTim e HIV 1 Qualitative (m 2000sp) 4N66 90, 9K14 02, 9K15 01, 4N66 80, 4N66 01, 6K12 24, 4N66 66 (optional) Abbott Molecular Inc. Des Plaines, IL, USA 4x24T pack 2013 HIV RDT SD BIOLINE HIV 1/ FK16 and 03FK10 30T/kit 2013 HIV EIA Genscreen ULTRA HIV Ag Ab 72386, Bio Rad Marnes La Coquette, France 2012 HIV RDT Uni Gold HIV , N, E, N 100 Trinity Biotech Manufacturing Ltd. Bray, Ireland 20T/kit; 100T/kit
8 : Rest of the world. Regulatory version applied to products not approved by stringent/mature NRAs or not regulated 2012 CD4 Pima CD4 Test and ; and Alere GmbH Jena, Germany 25 cartridges/kit and instrument; 100 cartridges/kit and instrument 2012 CD4 BD FACSCount Instrument System with FACSCount Control Kit and BD FACSCount Reagent Kit (Absolute CD4+, CD8+, and CD3+ Counts) , , Becton, Dickinson and Company, BD Biosciences San Jose, CA, USA : instrument system : 25T /kit : 2012 CD4 BD FACSCount Instrument System with FACSCount Control Kit and BD FACSCount CD4 Reagent Kit (Absolute and Percentage CD4+ Counts) , , Becton, Dickinson and Company, BD Biosciences San Jose, CA, USA and Cayey, Puerto Rico : instrument system : 25T/kit : 2012 COBAS AmpliPrep/COBAS TaqMan HIV 1 Test, version 2.0 (TaqMan 48) , , , , , , Roche Diagnostics GmbH Mannheim, Germany : 48T/kit : 5.1 liters 2012 COBAS AmpliPrep/COBAS TaqMan HIV 1 Test, version 2.0 (TaqMan 96) , , , , , , , Roche Molecular Systems, Inc. Branchburg, NJ, USA : 48T/kit : 5.1 liters
9 : Rest of the world. Regulatory version applied to products not approved by stringent/mature NRAs or not regulated 2012 HIV RDT HIV 1/2 STAT PAK HIV101 Chembio Diagnostic Systems Inc. Medford, NY, USA 20T/kit 2011 NucliSENS EasyQ HIV 1 v2.0 (Automated) ,280130, , ,280133, , ,200309, biomérieux SA Marcy L Etoile, France , , , and : 4x1L : 48 T/kit 2011 NucliSENS EasyQ HIV 1 v2.0 (Semi Automated) , , , , and biomérieux SA Marcy L Etoile, France and : 48T/kit, : 48 T/kit 2011 HIV RDT Alere Determine HIV 1/2 7D2342, 7D2343, 7D2343SET Alere Medical Co. Ltd. Matsudo shi, Chiba ken, Japan 20T/kit; 100T/kit; 100T/kit 2011 HIV RDT HIV 1/2 STAT PAK Dipstick HIV303 Chembio Diagnostic Systems Inc. Medford, NY, USA 1Tx30/kit 2011 Abbott RealTime HIV 1 (Manual) 2G31 (2G31 90, 2G31 80, 2G31 70), 2G31 66, 1L68 09, 9K15 01, 04J70 24, 04J71 93 Abbott Molecular Inc. Des Plaines, IL, USA 2G31 90: 96T/kit (4x24T); 2G31 80: 8 runs; 2G31 70: 4 calibration runs (1/6 months); 04J70 24: 96T/kit 2011 Abbott RealTim e HIV 1 (m 2000sp) 2G31 (2G31 90 or 2G31 010, 2G31 80, 2G31 70), 2G31 66, 1L68 09, 9K15 01, 04J70 24, 04J71 93, 9K14 02 Abbott Molecular Inc. Des Plaines, IL, USA 2G31 90: 96T/kit (4x24T) or 2G T/kit (4x24T); 2G31 80: 8 runs; 2G31 70: 4 calibration runs (1/6 months); 04J70 24: 96T/kit
10 : Rest of the world. Regulatory version applied to products not approved by stringent/mature NRAs or not regulated 2011 Abbott RealTim e HIV 1 (m 24sp) 3N06 01, 2G31(2G31 90, 2G31 80, 2G31 70), 2G31 66, 1L68 09, 9K15 01, 04J70 24, 04J71 93 Abbott Molecular Inc. Des Plaines, IL, USA 2G31 90: 96T/kit (4x24T); 2 G31 80: 8 runs; 2G31 70: 4 calibration runs (1/6 months); 04J70 24: 96T/kit 2010 Malaria RDT SD BIOLINE Malaria Ag P.f SD BIOLINE Malaria Ag P.f. (POCT) 05FK50, 05FK51, 05FK52, 05FK53 Giheung ku, Republic of 25T/kit, 25x1T/kit 1T/kit * Product originally in 2010 and amended in 2016 to include an additional product code. End of document
WHO list of prequalified in vitro diagnostic products
WHO list of prequalified in vitro diagnostic products : Rest of the world. Regulatory version applied to products not approved by stringent/mature NRAs or not regulated Last update: 22 December Year prequalified
WHO list of prequalified in vitro diagnostic products
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WHO list of prequalified in vitro diagnostic products
WHO list of in vitro diagnostic products : Rest of the world. Regulatory version applied to products not approved by stringent/mature NRAs or not regulated Last update: 21 December 2016 Year 2016 HIV RDT
WHO list of prequalified in vitro diagnostic products
WHO list of in vitro diagnostic products : Rest of the world. Regulatory version applied to products not approved by stringent/mature NRAs or not regulated Last update: 8 April 2016 Year 2016 HIV RDT OraQuick
WHO list of prequalified in vitro diagnostic products
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Initial sensitivity: 99% Initial sensitivity: 100% Final specificity: 98% Final specificity: 98%
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