NTM

Antigen, Inflammatory Response Marker, Sepsis

Product code: NTM
Device name: Antigen, Inflammatory Response Marker, Sepsis
Device class: Class 2
21 CFR: 21 CFR 866.3210
Medical specialty: Microbiology
Marketing pathway: 510(K)
510(k) clearances (all years, FDA): 3 (all years; only the last 3 years are listed here)

FDA classification definition

An immunoluminometric assay used to determine the concentration of procalcitonin (pct) in human serum and plasma.

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

Official FDA classification page: NTM

Classification and pathway per current FDA publications. Data from openFDA (CC0).