Dna-reagents, Mycobacterium Spp.
Microbiology · 21 CFR 866.3370
Recent MDR events
2 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
2 recall events for this product code
- Gen-Probe IncTerminatedMar 10, 2011
Mycobacterium Avium Complex Culture Identification Test Identification Test Kit, 2835.
This recall has been initiated following the identification of certain assay tubes that do not contain probe reagent. The affected kits may contain a combination of tubes with correct probe amount, partial probe amount and some probe tubes that are empty. Possible false negative results.
Z-1437-2011 · View FDA record ↗ - Gen-Probe IncTerminatedMar 10, 2011
Mycobacterium Tuberculosis Complex Culture Identification Test, 2860.
This recall has been initiated following the identification of certain assay tubes that do not contain probe reagent. The affected kits may contain a combination of tubes with correct probe amount, partial probe amount and some probe tubes that are empty. Possible false negative results.
Z-1438-2011 · View FDA record ↗
Registered firms
0 firms currently registered for this product code
No registered firms found for this product code.
510(k) clearances
15 clearances for this product code
- Gen-Probe, Inc.Jul 23, 1992
K921435 · ACCUPROBE MYCOBACTERIUM AVIUM COMPLEX CULTURE
- Gen-Probe, Inc.Nov 13, 1990
K904463 · ACCUPROBE MYCOBACTERIUM KANSASII CULT CONFIRM TEST
- Gen-Probe, Inc.Aug 23, 1990
K897077 · ACCUPROBE MYCOBACTERIUM INTRACELLULARE CULTURE
- Gen-Probe, Inc.Aug 23, 1990
K896494 · ACCUPROBE MYCOBACTERIUM AVIUM CULTURE TEST
- Gen-Probe, Inc.May 2, 1990
K897078 · ACCUPROBE MYCOBACTERIUM AVIUM COMPLEX CULTURE
- Gen-Probe, Inc.Apr 16, 1990
K896492 · ACCUPROBE MYCOBACTERIUM GORDONAE CULTURE TEST
- Gen-Probe, Inc.Apr 11, 1990
K896493 · ACCUPROBE MYCOBACTERIUM TUBERCULOSIS COMPLEX TEST
- Syngene, Inc.Apr 3, 1990
K900202 · SNAP MYCOBACTERIA AVIUM COMPLEX