Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission
Microbiology · 21 CFR 866.3215
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
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
1 recall events for this product code
Registered firms
9 firms currently registered for this product code
510(k) clearances
4 clearances for this product code
- Diasys Diagnostic Systems GmbHMay 9, 2025
K242294 · DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls
- Beckman Coulter, Inc.Apr 26, 2023
K222996 · Access PCT
- Beckman Coulter, Inc.Nov 26, 2019
K192271 · Access PCT, Access PCT Calibrators
- Diazyme LaboratoriesApr 18, 2017
K162297 · Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set