Home › Device types › LRF
Candida Spp., Direct Antigen, Id
FDA product code LRF · Class 2 · Microbiology
0
Registered devices
0
Adverse events
2
Recalls
3
510(k) clearances
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2009-01-13 | Lexamed | Candida albicans microbial suspension, certified to deliver less than 100 organisms per dose, was found to have a population count which exceeded 100 organisms |
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