PMT
5 FDA 510(k) clearances · Product code
89 daysmedian time to decision
353 days90th percentile
5clearances measured
FDA profile
- Official device name
- Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3215
- Medical specialty
- Microbiology
- FDA definition
- An assay used to determine the level of procalcitonin (PCT) in human serum and plasma as an aid in assessing the mortality for patients diagnosed with severe sepsis or septic shock.
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| Record | Firm | Date |
|---|---|---|
| VITROS BRAHMS PCT Reagent Pack and Calibrators (K200236) | Ortho Clinical Diagnostics | 2020-02-25 |
| Atellica IM BRAHMS Procalcitonin (PCT) (K181002) | Siemens Healthcare Diagnostics, Inc. | 2018-07-16 |
| VIDAS B.R.A.H.M.S. PCT (PCT) (K160911) | bioMerieux, Inc. | 2016-06-28 |
| Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5 (K160729) | Roche Diagnostics | 2016-06-13 |
| B.R.A.H.M.S PCT sensitive KRYPTOR (DEN150009) | Brahms GmbH | 2016-02-20 |
Track PMT automatically
Every clearance here is in the API, with alerts when new ones post.