Chemtrue ®COVID-19 （SARS-CoV-2）Antigen Rapid Test Kit(Nasal Swab)

Primary DI

D-CNM0000180720001LN

Basic UDI-DI Code

B-CNM0000180720001LN

Reference

8047C

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Shanghai Chemtron Biotech Co., Ltd.

The Chemtrue ® COVID-19 （SARS-CoV-2）Antigen Rapid Test Kit(Nasal Swab) is a qualitative membrane strip based indirect immunoassay for the detection of COVID-19 antigen from swab specimens collected from anterior nasal in human. According to the test procedure, COVID-19 monoclonal Ab-2 is immobilized in the test line region of the test. After the swab specimen is placed in the sample well, it will react with the COVID-19 monoclonal Ab-1 coated particles that have been applied to specimen pad. This mixture migrates chromatographically along the length of the test strip and interacts with the immobilized COVID-19 monoclonal Ab-2. If the specimen contains COVID-19 antigen, a colored line will appear in the test line region indicating a positive result. If the specimen does not contain COVID-19 antigen, a colored line will not appear in this region indicating a negative result. To serve as a procedural control, a colored line will always appear at the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.

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