Fungal Serology
Aspergillus fumigatus Antigen, 1mL
1manufacturer
5catalogue 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 | JWT |
| Device type | Antigen, Cf, Aspergillus Spp. |
| Device class | Class 1 |
| Regulation | 21 CFR 866.3040 |
| 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 |
|---|---|---|
| 200195 | Withdrawn | |
| 200285 | Withdrawn | |
| 200190 | Withdrawn | |
| 200200 | Withdrawn | |
| 200345 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Immy | Immuno-Mycologics, Inc. | 7 |
| Aspergillus fumigatus IgG Elisa | DRG Instruments Gesellschaft mit beschränkter Haftung | 3 |
| Aspergillus fumigatus IgG Elisa | DRG International, Inc. | 1 |
| 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.