FDA product code PTF

Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission

Microbiology·Class 2·21 CFR 866.3215
US regulatory classifications
US Product Code (FDA)
PTF
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 866.3215
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Medical specialty
Microbiology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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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About this record

Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission is a medical device type in the Microbiology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.