Pointe Glucose Reagent
Pointe Glucose Reagent packaged for use on the Mindray BA800. 8 x 66ml. For the in vitro quantitative measurement of glucose in serum.
2manufacturers in China registered for this device type
1catalogue number
16recalls on this 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 | Horiba Instruments Incorporated, United States |
|---|---|
| FDA product code | CFR |
| Device type | Hexokinase, Glucose |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1345 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K961282 |
| Record published | 2021-01-30 |
| Record revised | 2025-10-02 (version 3) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 16-G7517-528 | 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
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2016-01-11 | Class II | Under Investigation by firm | N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can interfere with the Trinder reaction that uses hydrogen peroxide catalytic on aminoantipyrine and phenol, and can produce falsely low results with t | 216 | 2016-06-07 |
| 2009-10-19 | Not classified | Process design | There is a loss of linearity. The product fails to maintain linearity specification of 500 mg/dL. | 400 kits plus 59 liters and 15 vials. | 2010-09-27 |
| 2008-09-10 | Not classified | Process control | The inability of the product to maintain stated performance specifications through the stated shelf life. | 4 | 2009-11-27 |
| 2008-09-10 | Not classified | Process control | The inability of the product to maintain stated performance specifications through the stated shelf life. | 8 | 2009-11-27 |
| 2008-09-10 | Not classified | Process control | The inability of the product to maintain stated performance specifications through the stated shelf life. | 63 | 2009-11-27 |
| 2008-09-10 | Not classified | Process control | The inability of the product to maintain stated performance specifications through the stated shelf life. | 9 | 2009-11-27 |
| 2008-09-10 | Not classified | Process control | The inability of the product to maintain stated performance specifications through the stated shelf life. | 10 | 2009-11-27 |
| 2008-09-10 | Not classified | Process control | The inability of the product to maintain stated performance specifications through the stated shelf life. | 37 | 2009-11-27 |
| 2006-06-07 | Not classified | Other | Product does not meet performance specifications through its labeled expiration period. | 13 kits | 2007-11-19 |
| 2006-06-07 | Not classified | Other | Product does not meet performance specifications through its labeled expiration period. | 153 kits | 2007-11-19 |
| 2006-06-07 | Not classified | Other | Product does not meet performance specifications through its labeled expiration period. | 10 kits | 2007-11-19 |
| 2006-06-07 | Not classified | Other | Product does not meet performance specifications through its labeled expiration period. | 279 bottles | 2007-11-19 |
| 2006-06-07 | Not classified | Other | Product does not meet performance specifications through its labeled expiration period. | 14 kits | 2007-11-19 |
| 2006-06-07 | Not classified | Other | Product does not meet performance specifications through its labeled expiration period. | 61 bottles | 2007-11-19 |
| 2006-06-07 | Not classified | Other | Product does not meet performance specifications through its labeled expiration period. | 425 bottles | 2007-11-19 |
| 2006-06-07 | Not classified | Other | Product does not meet performance specifications through its labeled expiration period. | 61 bottles | 2007-11-19 |
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.