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

Automated Electrochemiluminescence (ECL) Immunoassay Analyzer

Accucise Diagnostics Inc. · 🇨🇳 China
Devices (same UDI-DI)
3
Certificates
0
Countries
0
Notified Bodies
0

Basic Information

Primary DI
06975140163011
Basic UDI-DI Code
697509050YnY2050BH
Reference
A18111000003,A18111000004,A18111000005
Device Types
Single use
Regulation
Eu Ivdr
Classification
Eu Ivd Class A
Status
On The Market

Additional Description

Based on the ruthenium terpyridine [Ru(bpy)3]2+ and its derivatives of electrochemiluminescence immunoassay, the instrument is used in conjunction with the matching test reagent for the clinically qualitative or quantitative detection of analytes in human serum and plasma samples, including the laboratory diagnosis of myocardial diseases, immune function determination, hormone determination, tumor-associated antigen determination, and laboratory detection of infectious diseases.

CND Nomenclature Codes

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

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