Alinity
Alinity c Hemoglobin A1c Reagent Kit 1300 Tests
2manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
All of them in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medconn Medical Technology Co., Ltd. | Shanghai | Shanghai | Manufacturer | 2 |
| Shanghai Medconn Biotechnology Co., Ltd. | Jinshan District | Shanghai | Manufacturer | 2 |
Record
| Listed by | Abbott Medical, United States |
|---|---|
| FDA product code | PDJ |
| Device type | Hemoglobin A1c Test System |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1373 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2019-04-08 |
| Record revised | 2024-07-29 (version 4) |
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 30 °C; Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 08P4320 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| D-100 | Bio-Rad Laboratories Inc. | 4 |
| Architect | Abbott Medical | 3 |
| D-10 | Bio-Rad Laboratories Inc. | 3 |
| Afinion HbA1c Dx | Abbott Diagnostics Technologies AS | 2 |
| Tina-quant Hemoglobin A1cDx Gen.3 | Roche Diagnostics Gmbh | 2 |
| HbA1c Assay | Sekisui Diagnostics, LLC | 1 |
| Dimension Vista System Flex reagent cartridge A1C KIT | Siemens Healthcare Diagnostics Inc | 1 |
| Eluent 80B | Arkray USA, Inc. | 1 |
| BioHermes Automated Glycohemoglobin Analyzer | Wuxi Biohermes BIO & Medical Technology Co., Ltd. | 1 |
| Diluent 80 | Arkray USA, Inc. | 1 |
| Eluent 80A | Arkray USA, Inc. | 1 |
| Hemolysis Washing Solution 80H | Arkray USA, Inc. | 1 |
Showing 12 of 18. All products under Hemoglobin A1c Test System
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Abbott Laboratories | UDI-DI | 2022-06-09 | Class II | Under Investigation by firm | There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be generated using the ARCHITECT and Alinity c Hemoglobin A1c assay. | 7,391 units |
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.