Anti-Candida Albicans IFA (IgG)
4 catalogue numbers from FI 2861-1003 G, listed by Euroimmun Medizinische Labordiagnostika AG, Germany, under Candida Species, Antibody Detection. 1 manufacturer in China is registered for this product code.
1manufacturer
4catalogue 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 | Euroimmun Medizinische Labordiagnostika AG, Germany |
|---|---|
| FDA product code | LSG |
| Device type | Candida Species, Antibody Detection |
| Device class | Class 2 |
| Regulation | 21 CFR 866.3165 |
| Establishment | Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-24 |
| Record revised | 2022-11-15 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
| Distribution end date | 2022-05-25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FI 2861-1003 G | Withdrawn | |
| FI 2861-1005 G | Withdrawn | |
| FI 2861-2005 G | Withdrawn | |
| FI 2861-1010 G | Withdrawn |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 |
| Immy | Immuno-Mycologics, Inc. | 3 |
| Fungal Serology | Microbiologics, Inc. | 2 |
| 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.