Intended use:

For in vitro diagnostic use. The RIDA®UNITY E. coli Stool Panel I test, performed automatically or manually, is a multiplex real-time PCR for the direct qualitative detection of DNA for virulence factors of
– EHEC
– STEC
– EPEC
in human stool samples and culture samples from persons with signs and symptoms of acute gastroenteritis.
The RIDA®UNITY E. coli Stool Panel I test is intended to support the differential diagnosis of E. coli infections (EHEC, STEC and EPEC) 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 (EHEC, STEC and EPEC) and should not be used as the sole basis for diagnosis. The product is intended for professional use.

Specifications
Art. No. UN2285
Test format real-time PCR with 96 reactions
Files

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.

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