Intended use:
For in vitro diagnostic use. The RIDA®UNITY SARS-CoV-2 DT test, performed automatically or manually, is a multiplex real-time RT-PCR for the direct qualitative detection of:
– SARS-CoV-2 RNA
in human nasal/throat swabs from persons with signs and symptoms of acute respiratory infection.
The RIDA®UNITY SARS-CoV-2 DT test is intended to support the differential diagnosis of SARS-CoV-2 infections in patients with symptoms of respiratory infection, in connection with other clinical and laboratory findings.
Negative results do not rule out an infection with SARS-CoV-2 and should not be used as the sole basis for diagnosis.
The product is intended for professional use.
| Art. No. | UN6810 |
|---|---|
| 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.
