Intended use:
For in vitro diagnostic use. The RIDA®UNITY E. coli Stool Panel III test, performed
automatically or manually, is a multiplex real-time PCR for the direct qualitative
detection of DNA for virulence factors of
– ETEC
– EAEC
– EIEC/Shigella spp.
in human stool samples and culture samples from persons with signs and symptoms
of acute gastroenteritis.
The RIDA®UNITY E. coli Stool Panel III test is intended to support the differential
diagnosis of E. coli infections (ETEC, EAEC and EIEC/Shigella spp.) in patients with
symptoms of gastroenteritis in connection with other clinical and laboratory findings.
Negative results do not rule out an infection with E. coli (ETEC, EAEC and
EIEC/Shigella spp.) and should not be used as the sole basis for diagnosis.
The product is intended for professional use.
| Art. No. | UN2265 |
|---|---|
| Test format | real-time PCR with 96 reactions |
Dear customers,
we have started to provide the documents for our products in an electronic format. These are the Instructions for Use (IFU), the Safety Data Sheets (SDS) and the Certificate of Analysis (CoA). For batches placed on the market after 01 January 2023, you can find our documents on the eIFU portal eifu.r-biopharm.com/IVD.
