Product Code: SGA
FDA class 2
21 CFR 866.4000
Biothreat Microbial Agent Nucleic Acid Detection Test
Immunology
510(k)s
2
FEI Numbers
1
Registration Numbers
1
Unique Applicants
1
Years Active
0
Basic Information
- Product Code
- SGA
- Device Class
- FDA class 2
- Regulation Number
- 866.4000
- Medical Specialty
- Immunology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
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.
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K260812 | Francisella tularensis Real-time PCR Assay | Mar 30, 2026 | Substantially Equivalent | Centers for Disease Control and Prevention |
| K252072 | Francisella tularensis Real-time PCR assay | Sep 30, 2025 | Substantially Equivalent | Centers for Disease Control and Prevention |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.