Eu Ivdr
Eu Ivd Class C
On The Market
🇨🇳 China
CA15-3 CLIA Microparticles
Devices (same UDI-DI)
3
Certificates
0
Countries
3
Notified Bodies
0
Basic Information
- Primary DI
- 06970150908331
- Basic UDI-DI Code
- 697015090000009H2
- Reference
- CMB0702
- Device Types
- None provided
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class C
- Status
- On The Market
- Manufacturer
- Autobio Diagnostics Co., Ltd.
Additional Description
The CA15-3 CLIA Microparticles assay and AutoLumo CA15-3 Calibrators are used together based on the fully automated chemiluminescent microparticle immunoassay (CLIA Microparticles) system for the quantitative determination of CA15-3 (Carbohydrate Antigen 15-3) in human serum. Clinical determination of CA15-3 is used for dynamic monitoring of patients, which acts as an aid of disease progression or treatment determination of breast cancer.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102030102 | CANCER ANTIGEN 15-3 |
Available In Countries
🇮🇹 Italy
🇷🇴 Romania
🇹🇷 Türkiye
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