Architect
Haptoglobin
2manufacturers in China registered for this device type
1catalogue number
1recall
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 | Abbott Laboratories, United States |
|---|---|
| FDA product code | DAD |
| Device type | Haptoglobin, Antigen, Antiserum, Control |
| Device class | Class 2 |
| Regulation | 21 CFR 866.5460 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-06-06 |
| 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 | Handling environment temperature up to 29 °C; Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9D91-21 | 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 |
| Antiserum to Human Haptoglobin | Kent Laboratories, Inc. | 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 |
Showing 12 of 20. All products under Haptoglobin, Antigen, Antiserum, Control
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2018-05-16 | Class II | Under Investigation by firm | An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products. | 5,694 kits | 2021-08-16 |
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.