RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS

Primary DI

04049095210136

Basic UDI-DI Code

4049095UN27050000S8

Reference

UN2705

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 RIDA®UNITY CAP Bac test, performed on the RIDA®UNITY platform, is a multiplex real-time RT-PCR for the direct qualitative detection and differentiation of Chlamydophila pneumoniae DNA, Legionella pneumophila DNA, and Mycoplasma pneumoniae DNA in untreated human bronchoalveolar lavage (BAL) from persons with signs and symptoms of community-acquired pneumonia (CAP). The RIDA®UNITY CAP Bac test is intended to support the differential diagnosis of infection with Chlamydophila pneumoniae, Legionella pneumophila, and Mycoplasma pneumoniae in patients with symptoms of community-acquired pneumonia in conjunction with other clinical and laboratory findings. Negative results do not rule out infection with Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae and should not be used as the sole basis for diagnosis. The product is intended for professional use.

Other on-the-market devices with the same classification (Eu Ivd Class C) and regulation (EU IVDR).