Direct A1c Control Kit
A material which is used to verify the performance of Direct A1c Reagent Kit 55370.
3manufacturers in China registered for this device type
1catalogue number
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 | ELITechGroup Inc, United States |
|---|---|
| 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, Complaint-file establishment, Manufacturer |
| 510(k) | K031539 |
| Record published | 2023-10-01 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 55136 | 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
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.