HPV Genotyping Kit

Dénomination commerciale

HPV Genotyping Kit

06974987420073

B-06974987420073

Numéro de référence/catalogue

KS624-HPVC24

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 HPV Genotyping Kit is in vitro assay. The assay is for the detection and genotyping of DNA of Human Papillomavirus (HPV) in cervical specimens, including 18 subtypes of HPV (16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 73 and 82). The kit is for qualitative detection only. Human papillomavirus (HPV) is a major pathogen that induces benign lesions of external genitalia and cervical cancer in women. According to the risk of cervical cancer caused by the different types, it can be divided into low-risk and intermediate-risk and high-risk HPV. Persistent or repeated infection of high-risk HPV is the main cause of cervical cancer and cervical intraepithelial lesions (CIN2/3). This kit can detect 18 intermediate and high-risk HPV genotypes currently known to be associated with cervical cancer. Due to the high sensitivity and specificity, PCR technology is usually applied for early detection and differentiation of HPV while cervical biopsy is the final diagnosis basis for cervical cancer and high-grade cervical lesions. The detection results of this reagent should be comprehensively analyzed in combination with the results of cervical cytology and other relevant medical examinations, and should not be used alone as the basis for patient management."

URL des informations complémentaires

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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