QSTClass II
Lab-based Hiv Nat Diagnostic And/or Supplemental Test
Microbiology · 21 CFR 866.3957
Human immunodeficiency virus (HIV) lab-based nucleic acid diagnostic and supplemental tests are prescription devices for the qualitative detection of HIV nucleic acid in human body fluids or tissues.
MDR events12All time
Recalls0All time
Registered firms5Currently listed
510(k) clearances0All time
Recent MDR events
12 adverse event reports on file
- COBAS® HIV-1/HIV-2 QUALITATIVE (192T)Jun 3, 2026MalfunctionRoche Molecular Systems, Inc. - Branchburg2243471-2026-02175
- COBAS® HIV-1/HIV-2 QUALITATIVE (192T)May 13, 2026MalfunctionRoche Molecular Systems, Inc. - Branchburg2243471-2026-01882
- COBAS® HIV-1/HIV-2 QUALITATIVESep 26, 2025MalfunctionRoche Molecular Systems, Inc. - Branchburg2243471-2025-03776
- COBAS® HIV-1/HIV-2 QUALITATIVESep 24, 2025MalfunctionRoche Molecular Systems, Inc. - Branchburg2243471-2025-03578
- COBAS® HIV-1/HIV-2 QUALITATIVESep 24, 2025MalfunctionRoche Molecular Systems, Inc. - Branchburg2243471-2025-03612
- COBAS® HIV-1/HIV-2 QUALITATIVESep 18, 2025MalfunctionRoche Molecular Systems, Inc. - Branchburg2243471-2025-03116
- COBAS® HIV-1/HIV-2 (192T)Sep 11, 2025MalfunctionRoche Molecular Systems, Inc. - Branchburg2243471-2025-02844
- COBAS® HIV-1/HIV-2 QUALITATIVE (192T)Dec 12, 2024MalfunctionRoche Molecular Systems, Inc. - Branchburg2243471-2024-03634
- COBAS® HIV-1/HIV-2 QUALITATIVE (192T)Oct 7, 2024MalfunctionRoche Molecular Systems, Inc. - Branchburg2243471-2024-02902
- COBAS® HIV-1/HIV-2 QUALITATIVE (192T)Sep 25, 2024MalfunctionRoche Molecular Systems, Inc. - Branchburg2243471-2024-02761
Event type breakdown
Malfunction11
Injury1
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
5 firms currently registered for this product code
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.