PTF
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3215
- Medical specialty
- Microbiology
- FDA definition
- Assay to measure procalcitonin to aid in the risk assessment of critically ill patients on their first day of ICU admission for progression to severe sepsis and septic shock
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| Record | Firm | Date |
|---|---|---|
| DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls (K242294) | Diasys Diagnostic Systems GmbH | 2025-05-09 |
| Access PCT (K222996) | Beckman Coulter, Inc. | 2023-04-26 |
| Access PCT, Access PCT Calibrators (K192271) | Beckman Coulter, Inc. | 2019-11-26 |
| Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set (K162297) | Diazyme Laboratories | 2017-04-18 |
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Every clearance here is in the API, with alerts when new ones post.