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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 26, 2022 | K220262 | Dimension EXL LOCI BRAHMS Procalcitonin (PCT) Siemens Healthcare Diagnostics, Inc. | PRI |
| Mar 9, 2020 | K192815 | Elecsys BRAHMS PCT Roche Diagnostics | PRI |
| Jul 6, 2018 | K173927 | Elecsys BRAHMS PCT Roche Diagnostics | PRI |
| Feb 27, 2018 | K173683 | LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN Verifiers DiaSorin, Inc. | PRI |
| Dec 10, 2017 | K172713 | Lumipulse G BRAHMS PCT Immunoreaction Cartridges, Lumipulse G BRAHMS PCT Calibrators set Fujirebio Diagnostics,Inc. | PRI |
| Jun 1, 2017 | K170652 | ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT Controls Fisher Diagnostics | PRI |
| May 31, 2017 | K171338 | B R A H M S PCT sensitive KRYPTOR Brahms GmbH, DE | PRI |
| Feb 23, 2017 | K162827 | VIDAS B.R.A.H.M.S. PCT (PCT) bioMerieux, Inc. | PRI |
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