HbA1C
A Haemoglobin A1c test system is a device intended for the quantitative in vitro determination of Haemoglobin A1c concentration in whole blood
3manufacturers in China registered for this device type
2catalogue numbers in this listing
2510(k) clearances naming this product code
1recall
Who Else Makes It
Concentrated in Shanghai (2), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Wuxi Biohermes BIO & Medical Technology Co., Ltd. | Wuxi | Jiangsu | Manufacturer | 3 |
| Shanghai Medconn Medical Technology Co., Ltd. | Shanghai | Shanghai | Manufacturer | 2 |
| Shanghai Medconn Biotechnology Co., Ltd. | Jinshan District | Shanghai | Manufacturer | 2 |
Record
| Listed by | Randox Laboratories Limited, United Kingdom |
|---|---|
| FDA product code | LCP |
| Device type | Assay, Glycosylated Hemoglobin |
| Device class | Class 2 |
| Regulation | 21 CFR 864.7470 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K021897 |
| Record published | 2016-09-16 |
| Record revised | 2018-07-06 (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 |
| Storage | Special storage condition: stored protected from extreme heat, light, or freezing.; Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HA3830 | In distribution | |
| HA8321 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Trinity Biotech | Primus Corp. | 36 |
| Variant II Turbo | Bio-Rad Laboratories Inc. | 15 |
| Pointe Scientific, Inc. | Horiba Instruments Incorporated | 11 |
| Variant II Turbo Link | Bio-Rad Laboratories Inc. | 7 |
| D-10 | Bio-Rad Laboratories Inc. | 7 |
| Variant II Hemoglobin A1c | Bio-Rad Laboratories Inc. | 5 |
| Drew Scientific | Drew Scientific, Ltd. | 5 |
| Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 | Tosoh Corp. | 4 |
| D-100 | Bio-Rad Laboratories Inc. | 4 |
| Fructosamine | Roche Diagnostics Gmbh | 4 |
| D-10 Dual | Bio-Rad Laboratories Inc. | 3 |
| JAS Diagnostics | Drew Scientific, Ltd. | 3 |
Showing 12 of 134. All products under Assay, Glycosylated Hemoglobin
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K023763 | 2003-01-13 |
| K021897 | 2002-11-26 |
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 | Closed |
|---|---|---|---|---|---|---|---|
| Randox Laboratories Limited | 510(k) number | 2017-06-07 | Class II | Under Investigation by firm | Randox confirmed low calibration absorbance with HbA1c, Catalog Number HA3830, Batch 414553. The reagent may not continue to meet its specific performance characteristics throughout the shelf life of the product. | 90 kits | 2018-07-02 |
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.