Optilite Alpha-1-Acid Glycoprotein Kit
Catalogue number NK063.OPT.A, listed by The Binding Site Group Ltd., United Kingdom, under Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control. 2 manufacturers in China are registered for this product code.
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 | The Binding Site Group Ltd., United Kingdom |
|---|---|
| FDA product code | LKL |
| Device type | Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control |
| Device class | Class 1 |
| Regulation | 21 CFR 866.5420 |
| Establishment | Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-09-24 |
| Record revised | 2018-03-29 (version 2) |
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 |
|---|---|---|
| NK063.OPT.A | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Architect | Abbott Laboratories | 2 |
| Tina-quant Alpha 1-Acid Glycoprotein Gen.2 | Roche Diagnostics Gmbh | 2 |
| AU | Beckman Coulter Ireland Inc | 1 |
| Antiserum to Human Alpha 1 Acid Glycoprotein | Kent Laboratories, Inc. | 1 |
| K-Assay® Alpha-1 AG Reagent | Kamiya Biomedical Company LLC | 1 |
| alpha 1-Acid Glycoprotein | Sentinel CH. SPA | 1 |
| Advia® Chemistry AAG a1-Acid Glycoprotein Reagents | Siemens Healthcare Diagnostics Inc | 1 |
| Atellica CH AAG | Siemens Healthcare Diagnostics Inc | 1 |
| ALPHA-1-ACID-GLYCOPROTEIN (AGT) | Randox Laboratories Limited | 1 |
| Alinity | Abbott Laboratories | 1 |
| Tina-quant a1-Acid Glycoprotein Gen.2 | Roche Diagnostics Gmbh | 1 |
| Dimension Vista® a1-Acid Glycoprotein Flex® reagent cartridge | Siemens Healthcare Diagnostics Products GmbH | 1 |
Showing 12 of 14. All products under Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K922417 | 1992-08-20 |
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.