MJK
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Dna Probe, Trichomonas Vaginalis
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2660
- Medical specialty
- Microbiology
- Adverse events (MAUDE)
- 2013: 8 · 2014: 32
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| AFFIRM VP MICROBIAL ID TEST FOR TRICHOMONAS VAGINA (K922457) | Microprobe Corp. | 1992-09-25 |
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Every clearance here is in the API, with alerts when new ones post.