Eu Ivdr Eu Ivd Class A On The Market 🇨🇳 China

Chemiluminescence Analyzer

Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0

Basic Information

Primary DI
06947024409683
Basic UDI-DI Code
69470244021655T
Reference
Lumiray 630
Device Types
None provided
Regulation
Eu Ivdr
Classification
Eu Ivd Class A
Status
On The Market

Additional Description

The Chemical Luminescence Analyzer is based on the indirect chemical luminescence method of AMPPD and alkaline phosphatase (ALP). It is used with the supporting testing reagents. It is clinically used for qualitative or quantitative testing of analytes in blood serum, blood plasma and whole blood samples from the human body, including hormone testing, autoantibody testing, tumor-associated antigen determination, infectious diseases experiment and testing, proteins and peptides testing, experimental diagnosis of liver diseases, immunity determination, vitamins determination, experimental diagnosis of myocardial diseases, and D-dimer item determination.

CND Nomenclature Codes

Code Description
W0201020101 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)

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