C.DIFFICILE GDH DETECTION

Primary DI

04049095030116

Basic UDI-DI Code

4049095C070100000JW

Reference

C0701

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 GDH Test is a manual enzyme immunoassay for the direct qualitative detection of Clostridium difficile-specific glutamate dehydrogenase (GDH) in untreated human stool samples from persons with symptoms of gastroenteritis. The RIDASCREEN® Clostridium difficile GDH 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).