C.DIFFICILE TOXIN A/B DETECTION

Primary DI

04049095030017

Basic UDI-DI Code

4049095C080100000KH

Reference

C0801

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® Clostridium difficile Toxin A/B test is a manual enzyme immunoassay for the direct qualitative detection of Clostridium difficile toxin A and toxin B in untreated human stool samples from individuals with symptoms of gastroenteritis. RIDASCREEN® Clostridium difficile Toxin A/B is a diagnostic aid for the detection of a Clostridium difficile infection in conjunction with other clinical and laboratory findings. Negative results do not rule out infection with Clostridium difficile 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).