E. COLI TOXIN

Primary DI

04049095030857

Basic UDI-DI Code

4049095C220100000HD

Reference

C2201

Device Types

None provided

Regulation

Eu Ivdr

Classification

Eu Ivd Class C

Status

On The Market

Manufacturer

R-Biopharm AG

For in vitro diagnostic use. The RIDASCREEN® Verotoxin test is a manual enzyme immunoassay for the direct qualitative detection of verotoxin 1 and verotoxin 2 (synonyms: Shiga toxin 1 and Shiga toxin 2) in enrichment cultures (RIDA® Anreicherungsbouillon) of untreated human stool samples from people with symptoms of gastroenteritis. The RIDASCREEN® Verotoxin is a diagnostic aid for the detection of a bacterial infection with bacteria that produce verotoxin 1 and verotoxin 2 in conjunction with other clinical and laboratory findings. Negative results do not rule out infection with bacteria that produce verotoxin 1 or verotoxin 2 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 C) and regulation (EU IVDR).