GTX
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Antisera, Fluorescent, All Groups, Streptococcus Spp.
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3740
- Medical specialty
- Microbiology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| FLUORESCENT ANTIBODY CONJUGATE FOR GP.A (K812013) | Springwood Microbiologicals | 1981-07-28 |
| STREP B POLYVALENT FLUORO-KIT (K801876) | Clinical Sciences, Inc. | 1980-09-16 |
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Every clearance here is in the API, with alerts when new ones post.