Rapid Rota-Adenovirus Combo Test

Dénomination commerciale

Rapid Rota-Adenovirus Combo Test

06936155803859

B-06936155803859

Numéro de référence/catalogue

ITP14003-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 Rota-Adenovirus Combo Test is a rapid immunochromatographic assay for the qualitative detection of Rotavirus and Adenovirus antigens in human feces specimen. This test is used as an aid in the diagnosis of rotavirus and/or adenovirus 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 and Adenovirus are common viral causes of gastroenteritis, particularly in children, and fecal antigen detection supports diagnosis of viral gastrointestinal infection. The test is a sandwich solid-phase immunochromatographic assay. Diluted feces sample migrates by capillary action and, if Rotavirus and/or Adenovirus antigens are present, they bind to corresponding colloidal gold-labeled antibodies and are captured by immobilized specific antibodies at the test regions, forming colored test line(s). 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.

• W0105090699OTHER MULTIPLE PATHOGENS - RT & POC

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