CAMPYLOBACTER DIRECT ANTIGEN DETECTION

Primary DI

04049095030109

Basic UDI-DI Code

4049095C240100000JK

Reference

C2401

Device Types

None provided

Regulation

Eu Ivdr

Classification

Eu Ivd Class B

Status

On The Market

Manufacturer

R-Biopharm AG

For in-vitro diagnostic use. The RIDASCREEN® Campylobacter test is a manual enzyme immunoassay for the direct qualitative detection of Campylobacter jejuni and Campylobacter coli antigen in untreated human stool samples from individuals showing symptoms of gastroenteritis. RIDASCREEN® Campylobacter is a diagnostic aid for the detection of a C. jejuni and C. coli infection in conjunction with other clinical and laboratory findings. Negative results do not rule out infection with C. jejuni or C. coli and should not be used as the sole basis for diagnosis. The product is intended for professional use.

The Basic UDI-DI associated with this device has 5 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).