Fungal Serology
Candida Antiserum, 2mL
1manufacturer
2catalogue 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 | Microbiologics, Inc., United States |
|---|---|
| FDA product code | LSG |
| Device type | Candida Species, Antibody Detection |
| Device class | Class 2 |
| Regulation | 21 CFR 866.3165 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-09-26 |
| Record revised | 2024-02-09 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature -20 to -20 °C |
| Distribution end date | 2023-11-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 200180 | Withdrawn | |
| 200185 | Withdrawn |
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 |
| Candida albicans IgG Elisa | DRG International, Inc. | 1 |
| Candida albicans IgG Elisa | DRG Instruments Gesellschaft mit beschränkter Haftung | 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.