GMQ
- Product code
- GMQ
- Device name
- Antigens, Nontreponemal, All
- Device class
- Class 2
- 21 CFR
- 21 CFR 866.3820
- Medical specialty
- Microbiology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 32
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K250249 | 2025-10-10 | Gold Standard Diagnostics, LLC | Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma |
Official FDA classification page: GMQ
Classification and pathway per current FDA publications. Data from openFDA (CC0).