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Monitor,Test,Hiv-1

FDA product code MTL · Class 3 · Unknown

4
Registered devices
40
Adverse events
1
Recalls
0
510(k) clearances

Devices with this code

COBAS AMPLICOR HIV-1 Monitor Test, version 1.5 — Roche Molecular Systems, Inc.OraQuick Advance Rapid HIV 1/2 Antibody Test — Orasure Technologies, Inc.3D Dental — 3D DENTAL DESIGNS AND DEVELOPMENT, LLCOraQuick Advance HIV 1/2 Kit Controls — Orasure Technologies, Inc.

Recent recalls

DateFirmReason
2010-12-20Abbott MolecularInternal testing identified the potential of under filled and over filled enzyme reagent vials which may result in obtaining less than the total number of test

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.