RespiBio® Panel 1

Primary DI

05391513879913

Basic UDI-DI Code

B-05391513879913

Reference

RBRP1

Device Types

None provided

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Serosep Limited

The RespiBio® Panel 1 assay, is a molecular, in-vitro diagnostic test for qualitative detection of SARS-CoV-2 from RNA extracted from nasopharyngeal swabs (in viral transport medium) from individuals with signs and symptoms of respiratory infection. The assay utilises automated real-time polymerase chain reaction (PCR). This test is intended for use, in conjunction with clinical presentation, laboratory findings and epidemiological information, as an aid in the diagnosis of SARS-CoV-2 (COVID-19) infection in humans. Results of this assay should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Positive results do not rule out co-infection with other organisms that are not detected by this test and may not be the sole or definitive cause of patient illness. Negative results in the setting of clinical illness compatible with respiratory infection may be due to infection by pathogens that are not detected by this test.

Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).