TC8806

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

04049095200052

Basic UDI-DI

4049095TC88060000MU

Reference / catalog number

TC8806

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 diaqnostic use. The RIDASCREEN® TB is a manual enzyme immunoassay for the direct quantitative detection of interferon gamma-induced protein 10 (IP-10) from human plasma samples of individuals with suspected Mycobacterium tuberculosis infection (including disease). This IVD test is intended for use in conjunction with the RIDA®TB Tubes for in-vitro stimulation with specific M. tuberculosis antigens. The RIDASCREEN® TB is a diagnostic aid for indirect detection of M. tuberculosis infection (including disease) and is intended for use in conjunction with risk assessments, radiographic examinations, and other clinical and laboratory findings. Negative results do not rule out M. tuberculosis 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.

• W0105010799MYCOBACTERIA REAGENTS - OTHER

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