Eu Ivdr
Eu Ivd Class A
On The Market
๐จ๐ณ China
Chemiluminescence Immunoassay Analyzer IA-200
Devices (same UDI-DI)
1
Certificates
0
Countries
2
Notified Bodies
0
Basic Information
- Primary DI
- 06935740734004
- Basic UDI-DI Code
- 69357404IIA000001KW
- Reference
- /
- Device Types
- None provided
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class A
- Status
- On The Market
- Manufacturer
- URIT Medical Electronic Co.,Ltd.
Additional Description
The product uses AMPPD and alkaline phosphatase based indirect chemiluminescence method, and the supporting detection reagents are used in clinical practice for the qualitative or quantitative detection of analytes in serum, plasma and urine samples derived from the human body, including hormones, diabetes, myocardial markers, tumor markers, infectious diseases, infertility, self immunity and other related items. The test results as reference in clinical diagnosis, the final diagnosis needs to be determined by the doctor.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0201020102 | AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h) |
Available In Countries
๐ฉ๐ช Germany
๐ฎ๐น Italy
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