BNIBT

Primary DI

06975456580328

Basic UDI-DI Code

B-06975456580328

Reference

RI003C-20

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Beijing North Institute of Biotechnology Co.,Ltd.

Flu A/B Ag Rapid Test is a rapid immunochromatographic test for the visual detection of influenza type A and B antigens (nucleoprotein) extracted from the nasal swab specimen. The test adopts double antibody sandwich method. When the extracted specimen is added into the test device, the specimen is absorbed into the device by capillary action, mixes with antibody-dye conjugate, and flows across the pre-coated membrane, in which influenza type A and B monoclonal antibodies are coated respectively. When the influenza type A antigen levels are at or above the target cutoff (the detection limit of the test), type A antigen in the specimen binds to the specific antibody-dye conjugate and are captured by influenza type A monoclonal antibody immobilized in the relative site of test region “A” of the device. This produces a colored test band in the test region “A”. When the influenza type A antigen levels are zero or below the target cut off, there is not a visible colored band in the test region “A” of the device. This indicates a negative result for influenza type A. When the influenza type B antigen levels are at or above the target cutoff (the detection limit of the test), type B antigen in the specimen binds to the specific antibody-dye conjugate and are captured by influenza type B monoclonal antibody immobilized in the relative site of test region “B” of the device. This produces a colored test band in the test region “B”. When the influenza type B antigen levels are zero or below the target cut off, there is not a visible colored band in the test region “B” of the device. This indicates a negative result for influenza type B. To serve as a procedure control, a colored line will appear at the control region (C), if the test has been performed properly.

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