Eu Ivdr
Eu Ivd Class A
On The Market
🇰🇷 South Korea
CERA-STAT™ 4000 Analyzer
Devices (same UDI-DI)
1
Certificates
0
Countries
2
Notified Bodies
0
Basic Information
- Primary DI
- 08800065166008
- Basic UDI-DI Code
- 88000651HAAHM000C8
- Reference
- CS400M10
- Device Types
- None provided
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class A
- Status
- On The Market
- Manufacturer
- GC MEDIS Corp.
Additional Description
CERA-STAT™ 4000 Analyzer is designed to measure automatically 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. CERA-STAT™ HbA1c Test Kit is professionally used by medical laboratory technologists, nurses, and doctors in hospitals and clinical laboratories, and are also used as Near-patient Testing(NPT) device.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0201060101 | GLYCOSILATED HEMOGLOBIN DEVICEs |
Available In Countries
🇧🇪 Belgium
🇨🇾 Cyprus
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