Eu Ivdd
Eu Ivd General
On The Market
🇰🇷 South Korea
CERA-STAT™ 4000 Analyzer
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 08800065166008
- Basic UDI-DI Code
- B-08800065166008
- Reference
- CS400M10
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- GC MEDIS Corp.
Additional Description
CERA-STAT™ 4000 Analyzer is designed to measure glycated hemoglobin (HbA1c) and C-reactive protein (CRP) using CERA-STAT™ HbA1c Test Kit and CERA-STAT™ CRP Test Kit. It is an in vitro diagnostic medical device that measures the intensity of reflected light according to the concentration of analyte using spectrophotometric (optical) analysis.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0201060101 | GLYCOSILATED HEMOGLOBIN DEVICEs |
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