AU
α-1 Acidglycoprotein
2manufacturers in China registered for this device type
1catalogue number
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 | Beckman Coulter Ireland Inc, Ireland |
|---|---|
| FDA product code | LKL |
| Device type | Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control |
| Device class | Class 1 |
| Regulation | 21 CFR 866.5420 |
| Establishment | Contract manufacturer, Specification developer, 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 |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OSR6162 | 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 |
| Antiserum to Human Alpha 1 Acid Glycoprotein | Kent Laboratories, Inc. | 1 |
| K-Assay® Alpha-1 AG Reagent | Kamiya Biomedical Company LLC | 1 |
| Optilite Alpha-1-Acid Glycoprotein Kit | The Binding Site Group Ltd. | 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
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.