SGA — Biothreat Microbial Agent Nucleic Acid Detection Test Class II
FDA product code SGA covers "Biothreat Microbial Agent Nucleic Acid Detection Test", a Class II medical device regulated under 21 CFR 866.4000. Submissions are reviewed by the Immunology panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- SGA
- Device Class
- Class II
- Regulation Number
- 866.4000
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Immunology
- Implant
- No
Definition
A biothreat microbial agent nucleic acid detection test is a qualitative in vitro diagnostic device for the detection and identification of biothreat microbial agentassociated nucleic acids in human clinical specimens.