UN2405

Organization name

R-Biopharm AG

SRN

DE-MF-000007993

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• 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

04049095210556

Basic UDI-DI

4049095UN24050000QM

Reference / catalog number

UN2405

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 Bacterial Stool Panel test, performed automatically or manually, is a multiplex real-time PCR for the direct qualitative detection and differentiation of Campylobacter spp., Salmonella spp. and Yersinia enterocolitica DNA in human stool samples from persons with signs and symptoms of acute gastroenteritis. The RIDA®UNITY Bacterial Stool Panel test is intended to support the diagnosis of bacterial infections (Campylobacter spp., Salmonella spp. and Yersinia enterocolitica) in patients with symptoms of gastroenteritis in connection with other clinical and laboratory findings. Negative results do not rule out bacterial infection (Campylobacter spp., Salmonella spp. or Yersinia enterocolitica) 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.

• W0105070504GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification