NTM
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Antigen, Inflammatory Response Marker, Sepsis
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3210
- Medical specialty
- Microbiology
- FDA definition
- An immunoluminometric assay used to determine the concentration of procalcitonin (pct) in human serum and plasma.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| B R A H M S PCT SENSITIVE KRYPTOR TEST SYSTEM (K070310) | Brahms Aktiengesellschaft | 2008-03-31 |
| VIDAS B.R.A.H.M.S. PCT ASSAY (K071146) | bioMerieux, Inc. | 2007-10-11 |
| B-R-A-H-M-S PCT LIA (K040887) | Brahms Aktiengesellschaft | 2005-01-07 |
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Every clearance here is in the API, with alerts when new ones post.