Pointe Scientific Fructosamine Calibrator
The Fructosamine calibrator is derived from pooled human serum containing buffers, stabilizers and fillers. It is intended for use as a calibrator in the determination of fructosamine test…
The Fructosamine calibrator is derived from pooled human serum containing buffers, stabilizers and fillers. It is intended for use as a calibrator in the determination of fructosamine test systems to validate performance of the assay.
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 | Horiba Instruments Incorporated, United States |
|---|---|
| FDA product code | LCP |
| Device type | Assay, Glycosylated Hemoglobin |
| Device class | Class 2 |
| Regulation | 21 CFR 864.7470 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K993590 |
| Record published | 2016-08-31 |
| Record revised | 2025-10-02 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| F7546-CAL | 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.