Rapid Flu A/B Test

Dénomination commerciale

Rapid Flu A/B Test

06936155803828

B-06936155803828

Numéro de référence/catalogue

ITP081003-TC20

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 Rapid Flu A/B Test is a colloidal gold enhanced, rapid immunoassay for the qualitative detection of influenza A and influenza B viral nucleoprotein antigens in throat swab specimens. The test is intended for healthcare professional use only. Influenza infection is an acute feverish viral infection affecting the respiratory tract and may occur as an epidemic or pandemic. Influenza A is associated with serious clinical courses and epidemic spread, while influenza B commonly causes illness in children and fever. The test uses a two-site sandwich immunoassay principle. If influenza A and/or influenza B viral antigens are present, they form complexes with mouse monoclonal IgG antibodies to influenza A and/or B nucleoproteins conjugated to colloidal gold. The complexes are captured by immobilized anti-influenza A and/or B antibodies on the nitrocellulose membrane, producing corresponding test lines. The control line must appear for the result to be valid.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

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

• W0105099004INFLUENZA A AND /OR B - RT & POC

5 avertissements enregistrés — faire défiler le panneau pour tout voir.

• CW999

  1. The buffer/extraction buffer contains sodium azide as a preservative. If solution contacts skin or eyes, flush with ample water. Sodium azide may react explosively with lead or copper plumbing; flush discarded solutions with large quantities of water 2. Do not interchange or mix components from different kit lots
• CW032

  Do not use test sticks and reagents after expiration date
• CW011

  For professional in vitro diagnostic use only. Follow the package insert carefully. Follow clinical and laboratory safety guidelines in the collection, handling, storage and disposal of patient specimens and all items exposed to patient specimens. If infection with a novel influenza virus is suspected, specimens should be collected with appropriate infection control precautions and sent to the appropriate health authorities for testing
• CW010

  Read and follow the package insert carefully before use; Biological risks: Treat patient specimens and exposed items according to laboratory safety precautions and dispose of used materials appropriately