LRFClass II
Candida Spp., Direct Antigen, Id
Microbiology · 21 CFR 866.3165
MDR events0All time
Recalls2All time
Registered firms2Currently listed
510(k) clearances3All time
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
2 recall events for this product code
- GET TESTED INTERNATIONAL ABOpen, ClassifiedDec 1, 2025
Candida Test
Distribution without premarket approval/clearance.
Z-0775-2026 · View FDA record ↗ - LexamedTerminatedMar 31, 2009
BEC Growth Chek Microbial Suspension - Candida albicans CA1 (100 dose), Product #10231-100
Candida albicans microbial suspension, certified to deliver less than 100 organisms per dose, was found to have a population count which exceeded 100 organisms per dose, following distribution.
Z-1043-2009 · View FDA record ↗
Registered firms
2 firms currently registered for this product code