PG2705

Organization name

R-Biopharm AG

SRN

DE-MF-000007993

Manufacturer status

Active

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• CW999

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Primary placement in Germany; available across 32 countries total.

Trade name

not provided

UDI-DI code

04049095160615

Basic UDI-DI

4049095PG27050000GN

Reference / catalog number

PG2705

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®GENE CAP Bac test is a multiplex real-time PCR for the direct qualitative detection of Chlamydophila pneumoniae DNA, Legionella pneumophila DNA, and Mycoplasma pneumoniae DNA in human bronchoalveolar lavage (BAL) or nasal/throat swabs from individuals showing signs and symptoms of community-acquired pneumonia (CAP). The RIDA®GENE CAP Bac test is intended to support the diagnosis of infection with Chlamydophila pneumoniae, Legionella pneumophila, and Mycoplasma pneumoniae in patients with symptoms of community-acquired pneumonia in conjunction with other clinical and laboratory findings. Negative results do not rule out infection with Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae 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.

• W0105070503RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS

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