Hemolysis Washing Solution 80h
These products are used with the ADAMS A1c HA-8180 series for the determination of Hemoglobin A1c (HbA1c) in human whole blood. This product dilutes whole blood samples and is used to wash…
These products are used with the ADAMS A1c HA-8180 series for the determination of Hemoglobin A1c (HbA1c) in human whole blood. This product dilutes whole blood samples and is used to wash the sample tubes.
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 | Arkray USA, Inc., United States |
|---|---|
| FDA product code | PDJ |
| Device type | Hemoglobin A1c Test System |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1373 |
| 510(k) | K162822 |
| Record published | 2017-12-08 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 3 to 30 °C |
| Packaging | Carton of 3 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 103398 | 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 |
| 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 |
Showing 12 of 18. All products under Hemoglobin A1c Test System
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.