Immy
Aspergillus fumigatus ID Positive Control
1manufacturer
7catalogue numbers in this listing
1510(k) clearance
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 | Immuno-Mycologics, Inc., United States |
|---|---|
| FDA product code | JWT |
| Device type | Antigen, Cf, Aspergillus Spp. |
| Device class | Class 1 |
| Regulation | 21 CFR 866.3040 |
| 510(k) | K791387 |
| Record published | 2016-09-24 |
| Record revised | 2022-03-28 (version 4) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A70110 | In distribution | |
| AF0110 | In distribution | |
| A90110 | In distribution | |
| A80110 | In distribution | |
| A30110 | In distribution | |
| AD0110 | In distribution | |
| A10150 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Fungal Serology | Microbiologics, Inc. | 5 |
| 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 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K791387 | 1979-08-16 |
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.