NGS — Assay, Endotoxin Activity, Chemiluminescent Class II
FDA product code NGS covers "Assay, Endotoxin Activity, Chemiluminescent", a Class II medical device regulated under 21 CFR 866.3210. Submissions are reviewed by the Microbiology panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NGS
- Device Class
- Class II
- Regulation Number
- 866.3210
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No