Panels › Microbiology › Product code QIV · Class 2
Culture-Based Short-Term Incubation Antimicrobial Resistance Assay
Regulation 866.1655
0510(k)s in 12 months (1 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in QIV
| Company | 510(k)s | Recalls |
|---|---|---|
| Roche Molecular Systems, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 5, 2019 | DEN190016 | cobas vivoDx MRSA Roche Molecular Systems, Inc. | QIV |
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