Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06974671100489
- Basic UDI-DI Code
- B-06974671100489
- Reference
- DR-CLIA-CM-A010
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Darui Biotechnology Co., Ltd.
Additional Description
The kit is suitable for in vitro quantitative determination of cytokeratin 19 fragments (CYFRA 21-1) in human serum and plasma. It is mainly used for dynamic monitoring of patients with malignant tumor to assist in judging the disease process or treatment effect. It cannot be used as the basis for early or definitive diagnosis of malignant tumor, and is not intended for tumor screening in the general population.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102030111 | CYFRA 21-1 |
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