Candida Albicans IgG Elisa
The DRG Candida albicans IgG Enzyme Immunoassay Kit provides materials for the qualitative and semiquantitative determination of IgG-class antibodies to Candida albicans in serum.
1manufacturer
1catalogue number
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 | DRG Instruments Gesellschaft mit beschränkter Haftung |
|---|---|
| FDA product code | LSG |
| Device type | Candida Species, Antibody Detection |
| Device class | Class 2 |
| Regulation | 21 CFR 866.3165 |
| Premarket notification | Exempt |
| Record published | 2019-06-05 |
| Record revised | 2020-03-30 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EIA-3458 | 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 |
| Immy | Immuno-Mycologics, Inc. | 3 |
| Fungal Serology | Microbiologics, Inc. | 2 |
| Candida albicans IgG Elisa | DRG International, Inc. | 1 |
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.