COVID-19/FluA&B/RSV Ag Combo Rapid Test

Dénomination commerciale

COVID-19/FluA&B/RSV Ag Combo Rapid Test

06936155808304

B-06936155808304

Numéro de référence/catalogue

ITP182603-TC25

GS1

IVDD — Général

Législation applicable

IVDD [Directive 98/79/CE relative aux dispositifs médicaux de diagnostic in vitro]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

The COVID-19/FluA&B/RSV Ag Combo Rapid Test is a colloidal gold enhanced, rapid immunochromatographic assay for qualitative detection of antigens to SARS-CoV-2, Flu A, Flu B and/or RSV present in human nasopharyngeal/nasal/oropharyngeal specimens. The test is intended as an aid to the diagnosis of SARS-CoV-2, Flu A, Flu B and/or RSV infections. This test is intended for professional use. SARS-CoV-2, Influenza A, Influenza B and RSV are common pathogens causing respiratory tract infections with similar clinical symptoms. The test uses specific gold-conjugated antibodies to react with corresponding viral antigens in the specimen. If the target antigen is present, a visible colored band appears at the corresponding test region, while the control band indicates the validity of the test. Results are interpreted visually within 15–20 minutes

URL des informations complémentaires

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Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

Nomenclature européenne des dispositifs médicaux — la classification produit UE attribuée à ce dispositif.

• W0105090699OTHER MULTIPLE PATHOGENS - RT & POC

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• CW011

  For professional in vitro diagnostic use only. Follow the instructions for use carefully.
• CW010

  Consult the instructions for use before performing the test.
• CW009

  Do not reuse the test kit.
• CW007

  Do not use if the pouch is damaged or the seal is broken
• CW008

  Handle all specimens as potentially infectious and dispose of used materials as biohazardous waste.