Panels › Microbiology › Product code MWA · Class 2
System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex
Regulation 866.3372
0510(k)s in 12 months (0 all time)
0recalls in 12 months (2 all time)
0recalls that name a 510(k)
Top companies in MWA
| Company | 510(k)s | Recalls |
|---|---|---|
| Roche Molecular Systems Inc | 0 | 2 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 31, 2013 | Roche Molecular Systems, Inc. COBAS TaqMan Mycobacteria tuberculosis (MTB) Test FOR IN VITRO DIAGNOSTIC USE. Terminated |
MWA | None listed |
| Aug 19, 2004 | Roche Molecular Systems Inc Amplicor [3] AV-HRP, Avidin-HRP (Horseradish Peroxidase) BGG Conjugate.
Kit: AMPLICOR MTB Detection Kit, Gen 2 Export IVD/CE. Terminated |
MWA | None listed |
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