Eu Ivdd Eu Ivd General On The Market 🇨🇳 China

CANCER ANTIGEN 19-9

Darui Biotechnology Co., Ltd. · 🇨🇳 China
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0

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Basic Information

Primary DI
06974671100465
Basic UDI-DI Code
B-06974671100465
Reference
DR-CLIA-CM-A009
Device Types
None provided
Regulation
Eu Ivdd
Classification
Eu Ivd General
Status
On The Market

Additional Description

The kit is designed for in vitro quantitative measurement of carbohydrate antigen 19-9 (CA19-9) in human serum and plasma. The kit is mainly used for dynamic monitoring of malignant tumor patients to assist in judging the disease process or treatment effect. It cannot be used as a basis for early diagnosis or confirmation of malignant tumors, and cannot be used for tumor screening in the general population.

CND Nomenclature Codes

Code Description
W0102030103 CANCER ANTIGEN 19-9

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