Akso HPV Real-time PCR Kit

Dénomination commerciale

Akso HPV Real-time PCR Kit

06954414751154

695441479704KN

Numéro de référence/catalogue

RT6003

GS1

IVDR Classe C

Législation applicable

IVDR [Règlement (UE) 2017/746 relatif aux dispositifs médicaux de diagnostic in vitro]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

Akso HPV Real-time PCR Kit is a real-time PCR test intended for the qualitative detection of nucleic acid from HPV in cervical swabs collected from individuals suspected of having HPV. Results from the test should not be used as the sole basis for diagnosis and exclusion of HPV infection and patient management decisions. Positive results are indicative of the presence of HPV DNA. Negative results do not preclude HPV infection. Clinical observations, patient history, epidemiological information and other diagnostic information are also necessary to determine patient infection status. This kit is only intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures. For professional and laboratory use only.

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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.

• W0105041004FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS

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