3.151.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 5 pays au total.

Dénomination commerciale

non renseigné

Code d'UDI-DI

D-84295773151WMFN

Basic UDI-DI

B-84295773151WMFN

Numéro de référence/catalogue

3.151.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 YChromStrip test is a test for the detection of deletions in the Azospermia Factor (AZF) located on chromosome Y. These deletions are the cause of male infertility due to azospermia (absence of sperms) or oligospermia (low sperm count). The test detects the presence or absence of six STSs (sequence tagged sites) located in three different regions of the Azoospermia Factor: AZFa (sY84 and sY86), AZFb (sY127 and sY134) and AZFc (sY254 and sY255). The test also enables the verification of the presence of sequences from three genes: - ZFY (Zinc Finger Y region) and ZFX (Zinc Finger X region), two highly homologous genes located on chromosome Y and chromosome X, respectively, that are included to confirm the presence of DNA and that a proper amplification of the sample has occurred. - SRY (Sex reverse Y), located on the short arm of chromosome Y and main testicular determinant. This test is only a tool to help the professionals in the diagnosis of the indicated pathologies. This kit cannot be the only diagnosis tool.

URL des informations complémentaires

https://www.operondx.com/

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• W0106010199MONOGENETIC DISORDERS TESTS - OTHER

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