Afinion HbA1c Dx
Hemoglobin A1c test kit. Intended use: For determination of hemoglobin A1c in human whole blood including diagnosis. Contents: 15 Test Cartridges. 1 Package Insert.
2manufacturers in China registered for this device type
2catalogue numbers in this listing
1recall
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 Diagnostics Technologies AS, Norway |
|---|---|
| FDA product code | PDJ |
| Device type | Hemoglobin A1c Test System |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1373 |
| Establishment | Manufacturer |
| 510(k) | K180296 |
| Record published | 2019-05-31 |
| Record revised | 2019-05-09 (version 3) |
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 |
| Storage | Handling environment temperature 2 to 30 °C |
| Distribution end date | 2018-11-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1116794 | In distribution | |
| 1116482 | Withdrawn |
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 |
| Tina-quant Hemoglobin A1cDx Gen.3 | Roche Diagnostics Gmbh | 2 |
| Alinity | Abbott Medical | 1 |
| 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 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Abbott Diagnostics Technologies AS | 510(k) number | 2020-03-23 | Class II | Device Design | The analyzer system may have an electrostatic discharge and sparking of the power supply provided with the analyzers resulting in the power supply becoming non-functional. | 42,237 instruments |
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.