SGA
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Biothreat Microbial Agent Nucleic Acid Detection Test
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.4000
- Medical specialty
- Immunology
- FDA definition
- A biothreat microbial agent nucleic acid detection test is a qualitative in vitro diagnostic device for the detection and identification of biothreat microbial agent–associated nucleic acids in human clinical specimens.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| Francisella tularensis Real-time PCR Assay (K260812) | Centers for Disease Control and Prevention | 2026-03-30 | + Add |
| Francisella tularensis Real-time PCR assay (K252072) | Centers for Disease Control and Prevention | 2025-09-30 | + Add |
Track SGA automatically
Every clearance here is in the API, with alerts when new ones post.