← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

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

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.

DEVICE CLASS
Class II
REGULATION
21 CFR 866.3215
MEDICAL SPECIALTY
Microbiology
REVIEW PANEL
MI
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
0
510(K)/PMA CLEARANCES
0
RECALL ENTRIES

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →