DeviceClearance

Product code NTM— Microbiology

B R A H M S PCT SENSITIVE KRYPTOR TEST SYSTEM

Classification name
Antigen, Inflammatory Response Marker, Sepsis
Device class
Class 2
Regulation
21 CFR 866.3210
Advisory panel
Microbiology
Total cleared
3
First cleared
Most recent

FDA classification definition

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

— U.S. Food and Drug Administration, device classification record for product code NTM under 21 CFR 866.3210, via openFDA

Market context for product code NTM

FDA has cleared 3 devices under product code NTM between 2005 and 2008, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code NTM

Recent clearances under product code NTM

Data sourced from openFDA. This site is unofficial and independent of the FDA.