3.148.XXX.YY.ZZZ

Nom de l'organisation

OPERON, S.A.

SRN

ES-MF-000004790

Statut du fabricant

Actif

1 avertissement enregistré — faire défiler le panneau pour tout voir.

• CW265

  The denaturation solution contains < 2% NaOH

Marché principal en Espagne ; disponible dans 9 pays au total.

Dénomination commerciale

non renseigné

Code d'UDI-DI

D-84295773148WYHA

Basic UDI-DI

B-84295773148WYHA

Numéro de référence/catalogue

3.148.XXX.YY.ZZZ

Entité d'attribution

EUDAMED

Catégorie de risque

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 High + Low PapillomaStrip is based on the reverse blot technique to aid in the diagnosis of the infection caused by Papillomavirus, enabling the qualitative detection of DNA from 37 subtypes of the human papilloma virus (Papillomavirus): • Medium-to-high risk: 16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 69, 73 and 82 (MM4 and IS39). • Low risk: 6, 11, 40, 42, 43, 44, 54, 61, 62, 67, 70, 71, 72, 74, 81, 83, 84 and 91. The test is performed using DNA samples from the genitourinary tract, such as cervicovaginal swab and urine. Please also consider other parameters, such as any apparent symptoms and the patient’s medical history, when concluding a diagnosis. The test is qualitative and its whole execution is not automated, although parts of the process can be automated: 1. Hybridization/developing process: Automatic thermoshakers can be used (see point “Required equipment for kit development”. 2. Results interpretation: The results can be interpreted using a scanner (see point “Optional equipment for the interpretation of the strips”). This test is exclusively for in vitro diagnostic use. It is a professional use product. The product should be used in a genetics laboratory or a laboratory with the equipment required for molecular biology procedures (equipment for extracting DNA, preparing PCRs and subsequent analysis). This product is particularly indicated for genetics laboratories in hospitals and genetics diagnostic centres. It is not a self-testing product. It is not a near-patient testing product.

URL des informations complémentaires

https://www.operondx.com/

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

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

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