Antiserum to Human Haptoglobin
Goat antiserum to Human Haptoglobin
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 | Kent Laboratories, Inc., United States |
|---|---|
| FDA product code | DAD |
| Device type | Haptoglobin, Antigen, Antiserum, Control |
| Device class | Class 2 |
| Regulation | 21 CFR 866.5460 |
| Establishment | 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 |
|---|---|
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Advia® Chemistry Hapt Haptoglobin Reagents | Siemens Healthcare Diagnostics Inc | 2 |
| Tinaquant Haptoglobin ver2 | Roche Diagnostics Gmbh | 2 |
| Human Haptoglobin Kit for use on Spaplus | The Binding Site Group Ltd. | 1 |
| Haptoglobin (HP) | Randox Laboratories Limited | 1 |
| Haptoglobin Kit (Immunoturbidimetric Method) | Medicalsystem Biotechnology Co., Ltd. | 1 |
| Optilite Haptoglobin Kit | The Binding Site Group Ltd. | 1 |
| DImension Vista® Haptoglobin Flex® reagent cartridge | Siemens Healthcare Diagnostics Products GmbH | 1 |
| Architect | Abbott Ireland | 1 |
| Immage | Beckman Coulter, Inc. | 1 |
| Vitros | Ortho-Clinical Diagnostics, Inc. | 1 |
| AU | Beckman Coulter, Inc. | 1 |
| Synchron | Beckman Coulter, Inc. | 1 |
Showing 12 of 20. All products under Haptoglobin, Antigen, Antiserum, Control
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K831957 | 1983-07-18 |
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.