UN0505

Organization name

R-Biopharm AG

SRN

DE-MF-000007993

Manufacturer status

Active

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• CW999

  For warnings and precautions see IFU.

Primary placement in Germany; available across 32 countries total.

Trade name

not provided

UDI-DI code

04049095210044

Basic UDI-DI

4049095UN05050000PY

Reference / catalog number

UN0505

Issuing entity

GS1

Risk category

IVDR Class B

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 Flu test, performed automatically or manually, is a multiplex real-time RT-PCR for the direct qualitative detection and differentiation of influenza viruses (influenza A and influenza B) RNA in human nasal/throat swabs from persons with signs and symptoms of acute respiratory infection. The RIDA®UNITY Flu test is intended to support the differential diagnosis of influenza virus infections in patients with symptoms of respiratory infection in connection with other clinical and laboratory findings. Negative results do not rule out infection with influenza virus 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.

• W0105040504INFLUENZA & PARA INFLUENZA - NA REAGENTS

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