IDG/Sanzay
For the In Vitro quantitative determination of glucose in human serum or plasma.
2manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| Roche Diagnostics (Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 3 |
Record
| Listed by | IDG/Sanzay Corporation |
|---|---|
| FDA product code | CFR |
| Device type | Hexokinase, Glucose |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1345 |
| 510(k) | K000102 |
| Record published | 2024-06-25 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
| Sizes | Total volume 240 to 250 ml; total volume 1 l |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1 | Total Volume 250 ml | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Gluc-HK | Randox Laboratories Limited | 6 |
| Glucoquant GlucoseHK | Roche Diagnostics Gmbh | 3 |
| Glucose HK | Roche Diagnostics Gmbh | 3 |
| AU | Beckman Coulter, Inc. | 3 |
| Teco Diagnostics Glucose (Hexokinase) Reagent Set | Teco Diagnostics | 2 |
| Yumizen C1200 Glucose HK | Horiba ABX SAS | 2 |
| Architect | Abbott Laboratories | 2 |
| Alinity | Abbott Medical | 2 |
| Teco Diagnostics Glucose (Hexokinase) Liquid Reagent | Teco Diagnostics | 2 |
| Atellica CH GluH_3 | Siemens Healthcare Diagnostics Inc | 2 |
| Pointe Scientific, Inc. | Horiba Instruments Incorporated | 2 |
| Architect | Abbott Medical | 2 |
Showing 12 of 43. All products under Hexokinase, Glucose
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.