BNIBT

Primary DI

06975456580304

Basic UDI-DI Code

B-06975456580304

Reference

RFfFNC

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Beijing North Institute of Biotechnology Co.,Ltd.

The Fetal Fibronectin (fFN) Rapid Test is an immunochromatographic test for Fetal Fibronectin in pregnant women. The test uses murine monoclonal antibodies that specifically bind to fFN. Secretions sampled with a vaginal swab are extracted into a vial of extraction buffer. A dipstick is vertically introduced into the vial and the test sample is absorbed into the conjugate pad. This pad contains the first monoclonal antibody (conjugated to gold particles) which binds to any fFN present. The resulting antibody-FFN complex migrates along the dipstick membrane by capillary attraction to the test line where the immobilized second monoclonal antibody captures the complex by binding to FFN. This results in a red test line if FFN is present in the sample. The control line contains goat anti-mouse IgG which will bind to the first anti-FFN monoclonal antibody whether FFN is present in the sample or not. Binding creates a red control line that verifies the test is functioning properly.

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