Optilite Alpha-2-Macroglobulin Kit
Catalogue number NK039.OPT.A, listed by The Binding Site Group Ltd., United Kingdom, under Alpha-2-Macroglobulin, Antigen, Antiserum, Control. 2 manufacturers in China are registered for this product code.
2manufacturers 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).
| 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 | The Binding Site Group Ltd., United Kingdom |
|---|---|
| FDA product code | DEB |
| Device type | Alpha-2-Macroglobulin, Antigen, Antiserum, Control |
| Device class | Class 2 |
| Regulation | 21 CFR 866.5620 |
| Establishment | Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K140664 |
| Record published | 2016-09-24 |
| Record revised | 2018-07-06 (version 3) |
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 |
|---|---|---|
| NK039.OPT.A | 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 |
| Antiserum to Human Alpha 2 Macroglobulin | Kent Laboratories, Inc. | 1 |
| Immage | Beckman Coulter, Inc. | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K140664 | 2014-04-16 |
| K914389 | 1991-12-20 |
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.