RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER

Primary DI

06973914383108

Basic UDI-DI Code

B-06973914383108

Reference

H201.03.00171.001

Device Types

None provided

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Tianjin Bioscience Diagnostic Technology Co.,Ltd.

Novel Coronavirus (2019-nCoV) Antigen Rapid Test is for professional use only and is intended to be used as an aid in the diagnosis of SARS-CoV-2 infection. This kit intended for the in vitro qualitative detection of SARS- CoV-2 antigen in human nasal swab samples. This product cannot be used alone for the diagnosis of novel coronavirus infection. A positive result only indicates the possible presence of specific antigens of novel coronavirus in the sample and should be used in conjunction with nucleic acid test results to determine infection status. A negative result does not exclude novel coronavirus infection and should not be used alone as a basis for treatment and disease management decisions. Suspected patients with appropriate clinical symptoms should undergo further nucleic acid testing regardless of whether the antigen test is positive or negative. This product is for professionals, or those who have been instructed and trained by professionals.

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