Antiserum to Human Alpha 2 Macroglobulin
Goat antiserum to Human Alpha 2 Macroglobulin
2manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
Who Else Makes It
Concentrated in Jilin (1), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
Record
| Listed by | Kent Laboratories, Inc., United States |
|---|---|
| FDA product code | DEB |
| Device type | Alpha-2-Macroglobulin, Antigen, Antiserum, Control |
| Device class | Class 2 |
| Regulation | 21 CFR 866.5620 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-24 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Biobase | Biobase Biodustry(Shandong)Co., Ltd. | 2 |
| α2-Makroglobulin Elisa | Immundiagnostik, Inc. | 2 |
| Alpha2-Macroglobulin | Diagam | 2 |
| Human alpha 2 macroglobulin Kit for use on Spaplus | The Binding Site Group Ltd. | 1 |
| N Antiserum to Human a2-Macroglobulin | Siemens Healthcare Diagnostics Products GmbH | 1 |
| Dimension Vista® Flex® reagent cartridge A2MAC | Siemens Healthcare Diagnostics Products GmbH | 1 |
| Immage | Beckman Coulter, Inc. | 1 |
| Optilite Alpha-2-macroglobulin Kit | The Binding Site Group Ltd. | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K850683 | 1985-11-27 |
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.