Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
CANCER ANTIGEN 15-3
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06974671100427
- Basic UDI-DI Code
- B-06974671100427
- Reference
- DR-CLIA-CM-A006
- 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 designed for quantitative measurement of carbohydrate antigen 15-3 (CA15-3) in human serum. The test results of this kit do not provide definitive diagnoses. They are mainly used for the dynamic monitoring of patients with malignant tumors to gauge the disease progression or treatment efficacy. They cannot be used as the basis for early diagnosis or diagnosis of malignant tumors, and are not used for the tumor screening of the general population.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102030102 | CANCER ANTIGEN 15-3 |
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