PTF

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

Product code

PTF

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 2

21 CFR

21 CFR 866.3215

Medical specialty

Microbiology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

1

Summaries archived here

1 (direct download)

510(k) clearances (all years, FDA)

4 (all years; only the last 3 years are listed here)

FDA classification 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

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2025-05-09.

1 summaries are archived here for direct download.