MJM
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Dna Probe, Gardnerella Vaginalis
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2660
- Medical specialty
- Microbiology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| INDICARD TEST (K964015) | Litmus Concepts, Inc. | 1997-06-19 |
| AFFIRM/VP IDENT.TEST G.VAGINALIS & T.VAGINALIS (K923133) | Microprobe Corp. | 1992-09-25 |
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Every clearance here is in the API, with alerts when new ones post.