Eu Ivdr
Eu Ivd Class A
On The Market
🇨🇳 China
AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06972719600489
- Basic UDI-DI Code
- 6972719600007B3
- Reference
- 91E000401A
- Device Types
- None provided
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class A
- Status
- On The Market
- Manufacturer
- Nanjing RealMind Biotech Co., Ltd.
Additional Description
This product is clinically intended for qualitative or quantitative test of analytes in human serum, plasma, urine, whole blood and peripheral blood samples using direct chemiluminescence immunoassay based on acridinium esters in conjunction with test reagents supplied with the analyzer, including items such as hormones, tumor-associated antigens, infectious diseases, allergens, autoantibodies, proteins and polypeptides, sugars and metabolites, hepatic diseases, myocardial diseases, renal disorders, enzymes, vitamins and drugs, and osteoporosis.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0201020102 | AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h) |
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