Architect
2 catalogue numbers from 3L82-41, listed by Abbott Laboratories, United States, under Hexokinase, Glucose. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
2catalogue numbers in this listing
6510(k) clearances naming this product code
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 | Abbott Laboratories, United States |
|---|---|
| FDA product code | CFR |
| Device type | Hexokinase, Glucose |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1345 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-09-09 |
| Record revised | 2024-02-21 (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 | Handling environment temperature up to 29 °C; Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3L82-41 | In distribution | |
| 3L82-21 | 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 |
| 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 |
| ABX Pentra Glucose PAP CP | Horiba ABX SAS | 1 |
Showing 12 of 43. All products under Hexokinase, Glucose
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K170316 | 2017-10-19 |
| K060383 | 2006-05-05 |
| K981185 | 1998-05-07 |
| K894394 | 1989-10-03 |
| K882334 | 1988-08-09 |
| K843541 | 1984-09-28 |
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.