SGA — Biothreat Microbial Agent Nucleic Acid Detection Test Class II
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252072 | centers for disease control and prevention | Francisella tularensis Real-time PCR assay | September 30, 2025 |