NHSClass II
Assay, Genotype, Hiv Drug Resistance, In Vitro
Immunology · 21 CFR 866.3950
Hiv-1 drug resistance genotyping
MDR events11All time
Recalls0All time
Registered firms0Currently listed
510(k) clearances0All time
Recent MDR events
11 adverse event reports on file
- PRISM 6 CHANNEL ANALYZERMar 11, 2015MalfunctionAbbott Manufacturing Inc1628664-2015-00099
- PRISM 6 CHANNEL ANALYZERFeb 26, 2015MalfunctionAbbott Manufacturing Inc1628664-2015-00089
- ADVIA CENTAUROct 29, 2014MalfunctionSiemens Healthcare Diagnostics, Inc.2432235-2014-00625
- ADVIA CENTAUR XPMay 5, 2014MalfunctionSiemens Healthcare Diagnostics Inc.2432235-2014-00321
- ADVIA CENTAUR XPJan 31, 2014MalfunctionSiemens Healthcare Diagnostics Inc.2432235-2014-00156
- TRUGENE HIV-1 GENOTYPING KITMay 3, 2012MalfunctionSiemens Healthcare Diagnostics3003932969-2012-00003
- TRUEGENE HIV-1 GENOTYPING KITApr 27, 2012MalfunctionSiemens Medical Diagnostics3003932969-2012-00002
- ADVIA CENTAUR XPMar 6, 2012MalfunctionSiemens Healthcare Diagnostics, Inc.2432235-2012-00061
- ARCHITECT I2000 ANALYZERDec 23, 2009MalfunctionAbbott Manufacturing, Inc.1628664-2009-00781
- VERSANT 440 MOLECULAR SYSTEMFeb 19, 2009OtherSiemens Healthcare Diagnostics3003932969-2009-00002
Event type breakdown
Malfunction9
Other2
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
0 firms currently registered for this product code
No registered firms found for this product code.
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.