Optilite Beta 2 Microglobulin Urine Kit
Catalogue number LK043.L.OPT.A, listed by The Binding Site Group Ltd., United Kingdom, under System, Test, Beta-2-Microglobulin Immunological. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
1catalogue number
7510(k) clearances naming this product code
1recall
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 | The Binding Site Group Ltd., United Kingdom |
|---|---|
| FDA product code | JZG |
| Device type | System, Test, Beta-2-Microglobulin Immunological |
| Device class | Class 2 |
| Regulation | 21 CFR 866.5630 |
| Establishment | Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K122066 |
| Record published | 2016-09-24 |
| Record revised | 2022-10-10 (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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LK043.L.OPT.A | 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 |
| Beta-2 Microglobulin Elisa | American Laboratory Products Company | 1 |
| Human Beta-2 Microglobulin Nanorid Radial Immunodiffusion Kit | The Binding Site Group Ltd. | 1 |
Showing 12 of 32. All products under System, Test, Beta-2-Microglobulin Immunological
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K122066 | 2012-08-30 |
| K083289 | 2009-05-06 |
| K014270 | 2002-08-15 |
| K946070 | 1996-01-30 |
| K946068 | 1996-01-30 |
| K946069 | 1996-01-30 |
| K913131 | 1991-11-07 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| The Binding Site Group Ltd. | 510(k) number | 2018-03-09 | Class II | Under Investigation by firm | The product is not meeting the antigen excess protection claim of up to 760mg/L, as stated in the Instructions for Use. | 20 kits distributed to the U.S. | 2020-06-22 |
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.