UN2705

Organization name

R-Biopharm AG

SRN

DE-MF-000007993

Manufacturer status

Active

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• CW999

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Primary placement in Germany; available across 32 countries total.

Trade name

not provided

UDI-DI code

04049095210136

Basic UDI-DI

4049095UN27050000S8

Reference / catalog number

UN2705

Issuing entity

GS1

Risk category

IVDR Class C

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

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.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W0105070503RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS

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