N0823

Organization name

R-Biopharm AG

SRN

DE-MF-000007993

Manufacturer status

Active

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• CW010

  EUDAMED did not publish a description for this code.

Primary placement in Germany; available across 32 countries total.

Trade name

not provided

UDI-DI code

04049095140631

Basic UDI-DI

4049095N082300000XC

Reference / catalog number

N0823

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®Quick C. difficile GDH Toxin A/B Combi test is an immunochromatographic rapid test for the direct qualitative detection of C. difficile-specific glutamate dehydrogenase (GDH) C. difficile toxin A/B in human stool samples from individuals with symptoms of gastroenteritis. The test procedure is not automated. Interpretation of the results can be done visually or by using the R-Biopharm RIDA®Qi (ZRQ) reader. The RIDA®Quick C. difficile GDH Toxin A/B Combi test serves as a diagnostic aid for the detection of a C. difficile infection in conjunction with other clinical and laboratory findings. Negative results do not rule out a C. 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.

• W0105090106CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT & POC

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• Expiration date
• Manufacturing date
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