PMT

Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens

Product code

PMT

Device name

Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens

Device class

Class 2

21 CFR

21 CFR 866.3215

Medical specialty

Microbiology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

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

FDA classification definition

An assay used to determine the level of procalcitonin (PCT) in human serum and plasma as an aid in assessing the mortality for patients diagnosed with severe sepsis or septic shock.

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