D-100
D-100 HbA1c Elution Buffer B
2manufacturers in China registered for this device type
4catalogue numbers in this listing
3510(k) clearances naming this product code
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 | Bio-Rad Laboratories Inc., United States |
|---|---|
| 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, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-09-12 |
| Record revised | 2023-05-01 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 15 to 35 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 290-1011 | In distribution | |
| 290-1012 | In distribution | |
| 290-1007 | In distribution | |
| 290-1010 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| 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 |
|---|---|
| K161687 | 2016-10-14 |
| K151321 | 2015-12-09 |
| K142448 | 2015-03-24 |
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.