H. pylori Antibody Rapid Test

Primary DI

06936983109567

Basic UDI-DI Code

6970277510000EXK

Reference

IHP-N402J-25

Device Types

Single use

Regulation

Eu Ivdr

Classification

Eu Ivd Class B

Status

On The Market

Manufacturer

Hangzhou Alltest Biotech.Co.,Ltd.

The H. pylori Antibody Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of antibodies to H. pylori in whole blood, serum, or plasma to aid in the diagnosis of H. pylori infection. The H. pylori Antibody Rapid Test is intended to be used by trained laboratory personnel. For laboratory use only. The test provides preliminary test results and they can't be used as the sole basis for treatment or other management decision. Not for Self-testing use. Not for near-patient use. Not for detection of gastric cancer.

The Basic UDI-DI associated with this device has 6 devices in total. Below are some other devices sharing the same Basic UDI-DI.

Other on-the-market devices with the same classification (Eu Ivd Class B) and regulation (EU IVDR).