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

Chemiluminescence Immunoassay Analyzer

Devices (same UDI-DI)
1
Certificates
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Countries
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Basic Information

Primary DI
06975140170903
Basic UDI-DI Code
697514017Shinei9910JN
Reference
GS1
Device Types
None provided
Regulation
Eu Ivdr
Classification
Eu Ivd Class A
Status
On The Market

Additional Description

Chemiluminescence Immunoassay Analyzer performs complete sample processing (sample pre-dilutions, sample and reagent dispensing, incubations, wash processes, etc.) as well as measurement and evaluation to improve efficiency in the immunoassay laboratories. It adopts chemiluminescence immunoassay technology (CLIA) with paramagnetic microparticle solid phase. Chemiluminescence is the emission of light (luminescence) that is emitted by a substance when it returns from an excited state to a ground state, as the result of a chemical reaction. An immunoassay is a biochemical test that measures the presence or concentration of a macromolecule or a small molecule in a solution through the use of an antibody or immunoglobulin. CLIA, combining chemiluminescence with immunoassay, is ultra-sensitive and can detect small amounts of the biological molecule. In addition to this, it has a wider dynamic range, as well as having a linear relationship between luminous intensity and the concentration of the measured substance.

CND Nomenclature Codes

Code Description
W0201020104 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HIGH ROUTINE (Throughput > 700 test/h)

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