Immy
Cryptococcus Antigen EIA
1manufacturer
1catalogue number
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 | MDU |
| Device type | Antigen, Elisa, Cryptococcus |
| Device class | Class 2 |
| Regulation | 21 CFR 866.3165 |
| Record published | 2016-09-24 |
| Record revised | 2022-03-28 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| CRY101 | 96 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Premier Cryptococcal Antigen | Meridian Bioscience, Inc. | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K120946 | 2012-12-17 |
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.