Alpha-Tec Systems
Bovine Albumin Fraction V 10x10ml
2manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
Who Else Makes It
Concentrated in Zhejiang (1), Beijing (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Lysun Biotechnology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 22 |
| Beijing Genesee Biotech, Inc. | Beijing | Beijing | Manufacturer | 4 |
Record
| Listed by | Alpha-Tec Systems, Inc., United States |
|---|---|
| FDA product code | JSY |
| Device type | Kit, Identification, Mycobacteria |
| Device class | Class 1 |
| Regulation | 21 CFR 866.2660 |
| 510(k) | K880990 |
| Record published | 2022-08-09 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| QBC Diagnostics | Drucker Diagnostics, LLC | 2 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K880990 | 1988-03-24 |
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.