Eu Ivdr
Eu Ivd Class A
On The Market
🇨🇳 China
Fully Automated CLIA Analyzer
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06975070765477
- Basic UDI-DI Code
- 697507076CLSharay8000GV
- Reference
- 18920002
- Device Types
- None provided
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class A
- Status
- On The Market
- Manufacturer
- C-Luminary Biotechnology Co., Ltd.
Additional Description
The indirect chemiluminescence method based on AMPPD and alkaline phosphatase is used together with supporting reagents to carry out quantitative or qualitative detection of analytes in human serum, plasma, whole blood, cerebrospinal fluid and urine samples, including allergen detection, hormone detection, autoantibody detection, tumor related antigen detection, experimental detection of infectious diseases, protein and polypeptide detection, experimental diagnosis of liver disease, immune function detection, vitamin detection, experimental diagnosis of myocardial disease and D-Dimer detection.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W02020699 | RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER |
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