UN2265

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

04049095210525

Basic UDI-DI

4049095UN22650000RZ

Reference / catalog number

UN2265

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 E. coli Stool Panel III test, performed automatically or manually, is a multiplex real-time PCR for the direct qualitative detection of DNA for virulence factors of ETEC, EAEC and EIEC/Shigella spp. in human stool samples and culture samples from persons with signs and symptoms of acute gastroenteritis. The RIDA®UNITY E. coli Stool Panel III test is intended to support the differential diagnosis of E. coli infections (ETEC, EAEC and EIEC/Shigella spp) in patients with symptoms of gastroenteritis in connection with other clinical and laboratory findings. Negative results do not rule out an infection with E. coli (ETEC, EAEC and EIEC/Shigella spp) 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.

• W0105011503E. COLI DETECTION BY NA REAGENTS

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• Expiration date
• Manufacturing date
• Serial number
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