Eu Ivdr
Eu Ivd Class C
On The Market
๐บ๐ธ United States
Glucose
Devices (same UDI-DI)
1
Certificates
0
Countries
32
Notified Bodies
0
Basic Information
- Primary DI
- 15099590010195
- Basic UDI-DI Code
- 150995901OSR6121LT
- Reference
- OSR6121
- 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
๐ฆ๐น Austria
๐ง๐ช Belgium
๐ง๐ฌ Bulgaria
๐จ๐พ Cyprus
๐จ๐ฟ Czechia
๐ฉ๐ช Germany
๐ฉ๐ฐ Denmark
๐ช๐ช Estonia
๐ฌ๐ท Greece
๐ช๐ธ Spain
๐ซ๐ฎ Finland
๐ซ๐ท France
๐ญ๐ท Croatia
๐ญ๐บ Hungary
๐ฎ๐ช Ireland
๐ฎ๐ธ Iceland
๐ฎ๐น Italy
๐ฑ๐ฎ Liechtenstein
๐ฑ๐น Lithuania
๐ฑ๐บ Luxembourg
๐ฑ๐ป Latvia
๐ฒ๐น Malta
๐ณ๐ฑ Netherlands
๐ณ๐ด Norway
๐ต๐ฑ Poland
๐ต๐น Portugal
๐ท๐ด Romania
๐ธ๐ช Sweden
๐ธ๐ฎ Slovenia
๐ธ๐ฐ Slovakia
๐น๐ท Tรผrkiye
๐ฌ๐ง United Kingdom
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