Panels › Microbiology › Product code PRI · Class 2
Procalcitonin Assay
Regulation 866.3215
0510(k)s in 12 months (8 all time)
0recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in PRI
| Company | 510(k)s | Recalls |
|---|---|---|
| bioMerieux, Inc. | 1 | 1 |
| Roche Diagnostics | 2 | 0 |
| Brahms GmbH | 1 | 0 |
| DiaSorin, Inc. | 1 | 0 |
| Fisher Diagnostics | 1 | 0 |
| Fujirebio Diagnostics,Inc. | 1 | 0 |
| Siemens Healthcare Diagnostics, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 22, 2021 | bioMerieux, Inc. VIDAS B.R.A.H.M.S. PROCALCITONIN PCT, REF 30450-01 Open, Classified |
PRI | None listed |
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