UN2505

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

04049095210174

Basic UDI-DI

4049095UN25050000R6

Reference / catalog number

UN2505

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 Bordetella test, performed automatically or manually, is a multiplex real-time PCR for the direct qualitative detection and differentiation of Bordetella pertussis, Bordetella parapertussis and Bordetella holmesii DNA from human nasopharyngeal swabs from individuals with signs and symptoms of acute whooping cough. The RIDA®UNITY Bordetella test is intended to support the differential diagnosis of infection with Bordetella pertussis, Bordetella parapertussis and Bordetella holmesii in patients with symptoms of whooping cough in conjunction with other clinical and laboratory findings. Negative results do not rule out infection with Bordetella pertussis, Bordetella parapertussis and Bordetella holmesii 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.

• W0105011607BORDETELLA PERTUSSIS / PARAPERTUSSIS - NA REAGENTS

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