Aspergillus Fumigatus IgG Elisa
The Aspergillus fumigatus ELISA test is a qualitative enzyme immunoassay for the detection of Aspergillus fumigatus antibodies in human serum samples.
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 | Bordier affinity products S.A. |
|---|---|
| FDA product code | JWT |
| Device type | Antigen, Cf, Aspergillus Spp. |
| Device class | Class 1 |
| Regulation | 21 CFR 866.3040 |
| Premarket notification | Exempt |
| Record published | 2022-09-21 |
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 | Handling environment temperature -20 to 37 °C; Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6100 | 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 | 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.