Aspergillus Fumigatus IgG Elisa
The Aspergillus fumigatus IgG ELISA is intended for the qualitative determination of IgG class antibodies against Aspergillus fumigatus in human serum or plasma (citrate, heparin).
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 International, Inc., United States |
|---|---|
| FDA product code | JWT |
| Device type | Antigen, Cf, Aspergillus Spp. |
| Device class | Class 1 |
| Regulation | 21 CFR 866.3040 |
| Establishment | Repacker / relabeller, Complaint-file establishment |
| Premarket notification | Exempt |
| Record published | 2023-08-26 |
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, manufacturing date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EIA-6129 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Immy | Immuno-Mycologics, Inc. | 7 |
| Fungal Serology | Microbiologics, Inc. | 5 |
| Aspergillus fumigatus IgG Elisa | DRG Instruments Gesellschaft mit beschränkter Haftung | 3 |
| Aspergillus fumigatus IgG Elisa | Bordier affinity products S.A. | 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.