NTM — Antigen, Inflammatory Response Marker, Sepsis Class II
FDA product code NTM covers "Antigen, Inflammatory Response Marker, Sepsis", a Class II medical device regulated under 21 CFR 866.3210. Submissions are reviewed by the Microbiology panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NTM
- Device Class
- Class II
- Regulation Number
- 866.3210
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Definition
An immunoluminometric assay used to determine the concentration of procalcitonin (pct) in human serum and plasma.