VIROLOGY - RT & POC - OTHER

Primary DI

06975445472030

Basic UDI-DI Code

B-06975445472030

Reference

2019-nCoV IgM/IgG Antibody (whole blood/serum/plasma) Detection Kit

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

FARMASINO MEDICAL CO., LTD

This product is used to qualitatively detect 2019-nCoV IgM/lgG antibody in human serum and plasma. In view of the methodological characteristics of antibody detection reagents，the product is only used as a supplementary detection indicator for suspected cases of negative detection of nucleic acid or used in conjunction with nucleic acid detection in the diagnosis of suspected cases，and is not used as a basis for the diagnosis and elimination of pneumonia caused by novel coronavirus infection. It‘s not suitbale for general population screening.For medical institutions only.

Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).