Rapid Rotavirus Test

Dénomination commerciale

Rapid Rotavirus Test

06936155803637

B-06936155803637

Numéro de référence/catalogue

ITP14001-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 Rotavirus Test is a rapid immunochromatographic assay for the qualitative detection of Rotavirus antigen in human feces specimen. This test is used as an aid in the diagnosis of rotavirus infection and provides preliminary analysis results that should be interpreted together with clinical information and alternate tests. The test is for in vitro diagnostic use only. Rotavirus is a major cause of acute gastroenteritis, especially in infants and young children, and detection of rotavirus antigen in fecal specimens supports diagnosis of rotavirus-associated diarrhea. The test is a sandwich solid-phase immunochromatographic assay. Diluted feces sample migrates by capillary action and, if Rotavirus antigen is present, binds to anti-Rotavirus antibody conjugated to colloidal gold and is captured by immobilized anti-Rotavirus antibody at the test region to form a colored test line. The control line indicates that the test has been performed correctly and the device functions properly.

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.

• W0105040606ROTAVIRUS

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

• CW011

  For professional in vitro diagnostic use only. This rapid test is used as an aid for diagnosis, provides preliminary analytical results only, and positive results should be confirmed by an alternate method. Results should be interpreted together with clinical information and other laboratory findings
• CW010

  Read and follow the package insert carefully before use
• CW008

  Treat all specimens as potentially infectious. Wear gloves and protective clothing when handling specimens, follow laboratory safety guidelines, and dispose of specimens and used devices in a proper biohazard container
• CW009

  Do not re-use the test cards or any single-use accessories
• CW032