Eu Ivdd Eu Ivd General On The Market 🇨🇳 China

Novel coronavirus(SARS-CoV-2)Neutralizing Antibody Detection Kit (ELISA)

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

Basic Information

Primary DI
06974593880100
Basic UDI-DI Code
B-06974593880100
Reference
NAD01
Device Types
None provided
Regulation
Eu Ivdd
Classification
Eu Ivd General
Status
On The Market

Additional Description

The kit uses enzyme-linked immunosorbent assay (ELISA) to quantify detection or qualitative detection of SARS-CoV-2 neutralizing antibodies in human serum/plasma samples. SARS-CoV-2 is a kind of new β-type coronavirus with envelope outside and particle in round or oval shape. It includes spike protein (S), envelope protein (E), membrane protein (M) and nucleocapsid protein (N). The spike protein (S) contains the receptor binding domain (RBD), which is responsible for recognizing the cell surface receptor angiotensin converting enzyme 2 (ACE2), causing virus replication in the host cell by endocytosis. And the SARS-CoV-2 infection triggers an immune response to produce binding antibodies. The binding antibodies that can block the cell infiltration and replication of the virus are called neutralizing antibodies.

CND Nomenclature Codes

Code Description
W0105040699 VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER

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