W0105040601

Dénomination commerciale

W0105040601

06936155803842

B-06936155803842

Numéro de référence/catalogue

ITP14002-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 Adenovirus Test is a rapid immunochromatographic assay for the qualitative detection of Adenovirus antigen in human feces specimen. This test is a rapid test as an aid in the diagnosis of relative infection and to monitor the effectiveness of therapeutic treatment; it only provides preliminary analysis results and the obtained results should be analyzed together with clinical information and alternate tests to make a final decision. The test is for in vitro diagnostic use only. Adenoviral infections affect infants and young children more frequently than adults and can cause respiratory, ocular and gastrointestinal disease; fecal adenovirus antigen detection supports the diagnosis of adenovirus-associated gastroenteritis. The test is a sandwich solid-phase immunochromatographic assay. Diluted feces sample migrates by capillary action and, if Adenovirus antigen is present, binds to anti-Adenovirus antibody conjugated to colloidal gold and is captured by immobilized anti-Adenovirus antibody at the test region to form a colored 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.

• W0105040601ADENOVIRUS

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• Avertissement

  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

• Consulter la notice d’utilisation

  Read and follow the package insert carefully before use

• Risques biologiques

  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

• Ne pas réutiliser

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

• Ne pas utiliser après la date indiquée

  Do not use kit materials beyond their expiration dates