Alinity
Alinity c B2-Microglobulin Reagent Kit 200 Tests
3manufacturers in China registered for this device type
1catalogue number
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jilin (1), Shandong (1), Hebei (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 |
| Shijiazhuang Hipro Biotechnology Co., Ltd. | Shijiazhuang | Hebei | Manufacturer | 22 |
Record
| Listed by | Abbott Laboratories, United States |
|---|---|
| FDA product code | JZG |
| Device type | System, Test, Beta-2-Microglobulin Immunological |
| Device class | Class 2 |
| Regulation | 21 CFR 866.5630 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2019-01-04 |
| Record revised | 2023-08-17 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C; Handling environment temperature up to 30 °C; Special storage condition: Do not freeze |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 01R0921 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Biobase | Biobase Biodustry(Shandong)Co., Ltd. | 11 |
| Tinaquant 2Microglobulin | Roche Diagnostics Gmbh | 3 |
| Tina-quant ß2-Microglobulin | Roche Diagnostics Gmbh | 2 |
| Immulite/Immulite 1000 Systems Beta-2-Microglobulin Sample Diluent | Siemens Healthcare Diagnostics Products GmbH | 2 |
| B2Microglobulin (B2M) | Randox Laboratories Limited | 2 |
| Advia® Chemistry B2M ß2-Microglobulin Reagents | Siemens Healthcare Diagnostics Inc | 1 |
| N Latex ß2-Microglobulin | Siemens Healthcare Diagnostics Products GmbH | 1 |
| Optilite® Beta-2 Microglobulin Kit | The Binding Site Group Ltd. | 1 |
| N a1-Microglobulin Kit | Siemens Healthcare Diagnostics Products GmbH | 1 |
| Dimension Vista® ß2-Microglobulin Flex® reagent cartridge | Siemens Healthcare Diagnostics Products GmbH | 1 |
| Optilite Beta 2 Microglobulin Urine Kit | The Binding Site Group Ltd. | 1 |
| Beta-2 Microglobulin Elisa | American Laboratory Products Company | 1 |
Showing 12 of 32. All products under System, Test, Beta-2-Microglobulin Immunological
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K890421 | 1989-03-09 |
| K864130 | 1986-11-12 |
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.