MLA
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Dna Probe, Yeast
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2660
- Medical specialty
- Microbiology
- Adverse events (MAUDE)
- 2025: 165
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(TM) VPIII MICROBIAL IDENT TEST FOR CANDIDA (K931151) | Microprobe Corp. | 1993-06-18 |
| AFFIRM VPIII MICROBIAL IDENTIFICATION TEST (K931374) | Microprobe Corp. | 1993-06-15 |
Track MLA automatically
Every clearance here is in the API, with alerts when new ones post.