BACTERIOLOGY IMMUNOASSAY - OTHER

Primary DI

04049095030000

Basic UDI-DI Code

4049095C060100000JB

Reference

C0601

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 perfringens Enterotoxin is a manual enzyme immunoassay for the direct qualitative detection of Clostridium perfringens enterotoxin in untreated human stool samples from people with symptoms of gastroenteritis. The RIDASCREEN® Clostridium perfringens Enterotoxin is a diagnostic aid for the detection of a bacterial infection with enterotoxin-producing Clostridium perfringens bacteria in conjunction with other clinical and laboratory findings. Negative results do not rule out infection with enterotoxin-producing Clostridium perfringens bacteria 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).