Chemtrue ®® Influenza A+B Antigen Combo Rapid Test (Lateral Flow)

Primary DI

D-CNM0000180720007M2

Basic UDI-DI Code

B-CNM0000180720007M2

Reference

8010C

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Shanghai Chemtron Biotech Co., Ltd.

The Influenza A+B Ag Combo Rapid Test is a qualitative membrane strip based indirect immunoassay for the detection of influenza A antigen and influenza B antigen from swab specimens collected from nasopharynx or oropharynx. According to the test procedure, influenza A monoclonal Ab-2 was immobilized in the test line A region of the test and influenza B monoclonal Ab-2 was immobilized in the test line B region of the test. After the swab specimen is added in the sample well, it reacts with the influenza A monoclonal Ab-1 coated particles and the influenza B 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 influenza A monoclonal Ab-2 and influenza B monoclonal Ab-2. If the specimen contains influenza A antigen, a colored line will appear in the test line A region indicating a positive result. If the specimen contains influenza B antigen, a colored line will appear in the test line B region indicating a positive result. If the specimen does not contain influenza A antigen or influenza B antigen, colored line will not appear in test line A region and test line B 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).