Immy
Candida ID Positive Control
1manufacturer
3catalogue numbers in this listing
Who Else Makes It
Registered in Tianjin.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dynamiker Biotechnology (Tianjin) Co., Ltd. | Tianjin | Tianjin | Manufacturer | 3 |
Record
| Listed by | Immuno-Mycologics, Inc., United States |
|---|---|
| FDA product code | LSG |
| Device type | Candida Species, Antibody Detection |
| Device class | Class 2 |
| Regulation | 21 CFR 866.3165 |
| 510(k) | K791383 |
| Record published | 2016-09-24 |
| Record revised | 2024-09-19 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| C50110 | In distribution | |
| CA1001 | In distribution | |
| C60110 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Anti-Candida albicans IFA (IgA) | Euroimmun Medizinische Labordiagnostika AG | 5 |
| Anti-Candida albicans IFA (IgM) | Euroimmun Medizinische Labordiagnostika AG | 4 |
| Anti-Candida albicans IFA (IgG) | Euroimmun Medizinische Labordiagnostika AG | 4 |
| Fungal Serology | Microbiologics, Inc. | 2 |
| Candida albicans IgG Elisa | DRG International, Inc. | 1 |
| Candida albicans IgG Elisa | DRG Instruments Gesellschaft mit beschränkter Haftung | 1 |
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Immy, Inc. | UDI-DI | 2025-02-10 | Class II | Process change control | Candida Immunodiffusion Antigen may have reduced sensitivity which could result in false negative results. | 30 vials |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.