Antigen, Cf And / Or Id, Coccidioides Immitis
FDA product code GMI · Class II (moderate risk) · 21 CFR 866.3135 · Microbiology
11510(k) clearances
0PMA approvals
1recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K894617 | Olympus Pk-Tp System Reactive ControlGMI · Traditional | Schiff & Co. | 10/31/1989SE |
| K812190 | Coccidioides Immunodiffusion SystemGMI · Traditional | American Scientific Products | 08/31/1981SE |
| K812185 | Fungal Immunodiffusion SystemGMI · Traditional | American Scientific Products | 08/25/1981SE |
| K802129 | Immunodiffusion Reagents/SerologicalGMI · Traditional | Nolan Biological Laboratories, Inc. | 09/26/1980SE |
| K792716 | Candida Albicans, AntigenGMI · Traditional | Meridian Diagnostics, Inc. | 01/24/1980SE |
| K792713 | Candida Albicans, AntiserumGMI · Traditional | Meridian Diagnostics, Inc. | 01/23/1980SE |
| K792689 | Coccidioides Immitis, AntigenGMI · Traditional | Meridian Diagnostics, Inc. | 01/17/1980SE |
| K792682 | Coccidioides Immitis, AntigenGMI · Traditional | Meridian Diagnostics, Inc. | 01/17/1980SE |
| K791389 | Coccidioides Antigen #CF10023XGMI · Traditional | Immuno-Mycologics, Inc. | 08/16/1979SE |
| K791383 | Candida Immunodiffusion Kit #CA1001GMI · Traditional | Immuno-Mycologics, Inc. | 08/16/1979SE |
| K770527 | Candida Immunodiffusion KitGMI · Traditional | I M, Inc. | 03/17/1978SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1389-2025 Class II | Candida ID Antigen, REAG, AG, REF C50110, Vol 1 mL REF ID1001, Immy Fungal Antigens…Candida Immunodiffusion Antigen may have reduced sensitivity which could result in false negative results. | Immuno-Mycologics, Inc | 02/10/2025Open, Classified |