Glucose
Let the assistant research this device
The Research Assistant compiles risk class, certificates, notified bodies and related records โ and cites every one.
Free to try ยท every answer cites its records
Basic Information
- Primary DI
- 15099590060084
- Basic UDI-DI Code
- 150995901OSR6621ML
- Reference
- OSR6621
- Device Types
- None provided
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class C
- Status
- On The Market
- Manufacturer
- Beckman Coulter Inc.
Additional Description
Glucose reagent is an in vitro diagnostic medical device intended to be used by healthcare professionals for the quantitative enzymatic UV measurement of glucose in human serum, plasma, urine, and cerebrospinal fluid (CSF) using the automated Beckman Coulter AU/DxC AU analyzers. Measurement of glucose is intended to be used as an aid in the diagnosis and treatment of disorders of carbohydrate metabolism including diabetes mellitus, neonatal hypoglycemia, and insulinoma. Measurement of glucose in CSF is intended to be used as an aid in diagnosis of CNS infection.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W01010213 | GLUCOSE |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Class C) and regulation (EU IVDR).