UN0835

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

04049095210068

Basic UDI-DI

4049095UN08350000SS

Reference / catalog number

UN0835

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 C. difficile test, performed automatically or manually, is a multiplex real-time PCR for the direct qualitative detection of Clostridioides difficile DNA and Clostridioides difficile-Toxin A/B DNA in untreated stool samples from persons with signs and symptoms of acute gastroenteritis. The RIDA®UNITY C. difficile test is intended to support the differential diagnosis of Clostridioides difficile infections in patients with symptoms of gastroenteritis in connection with other clinical and laboratory findings. Negative results do not rule out Clostridioides difficile infection 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.

• W0105011804C.DIFFICILE BY NA REAGENTS

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• Expiration date
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