Tina-Quant Hemoglobin A1cDx Gen.3
2 catalogue numbers from 08056668190, listed by Roche Diagnostics Gmbh, Germany, under Hemoglobin A1c Test System. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
2catalogue numbers in this listing
1510(k) clearance
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 | Roche Diagnostics Gmbh, Germany |
|---|---|
| FDA product code | PDJ |
| Device type | Hemoglobin A1c Test System |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1373 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K160571 |
| Record published | 2020-04-14 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 08056668190 | In distribution | |
| 07559674190 | 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 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| DEN130002 | 2013-05-23 |
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.