Panels › Microbiology › Product code LRF · Class 2
Candida Spp., Direct Antigen, Id
Regulation 866.3165
0510(k)s in 12 months (3 all time)
1recalls in 12 months (2 all time)
1recalls that name a 510(k)
Top companies in LRF
| Company | 510(k)s | Recalls |
|---|---|---|
| GET TESTED INTERNATIONAL AB | 0 | 1 |
| Immuno-Mycologics, Inc. | 1 | 0 |
| Lexamed | 0 | 1 |
| Medi-Tech, Inc. | 1 | 0 |
| Mercia Diagnostics , Ltd. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Candida Test Open, Classified |
LRF | None listed |
| Mar 31, 2009 | Lexamed BEC Growth Chek Microbial Suspension - Candida albicans CA1 (100 dose), Product #10231-100
Liquid suspensions used for performing USP Growth Promotion and Bacteriostasis/Fungistasis testing and othe Terminated |
LRF | K842579 |
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