3.135.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-84295773135WPG2

Basic UDI-DI

B-84295773135WPG2

Numéro de référence/catalogue

3.135.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

LactoStrip Test is a test designed for the detection of two MCM6 gene polymorphisms associated with the persistence of lactase activity in adults: C/T 13910 and G/A 22018. In most humans, the ability to digest the lactose (the main carbohydrate present in the milk) quickly decreases after the end of lactation period (primary lactose intolerance). This is due to a reduction of the enzyme lactase–phlorizin hydrolase (LPH), responsible for the hydrolysis of lactose to glucose and galactose, sugars that are easily absorbed in the intestine. However, certain individuals, mainly descendants of traditionally cattle-raising peoples, retain the ability to digest lactose in adulthood. The frequency of the lactase activity persistence is high in northern Europe populations (>90 % in Swedes and Danes), decreases as we go down towards southern Europe and Middle East (approximately 50 % in France, Spain and certain Arab populations) and is very low in Asiatic and African populations not devoted to pasturage (approximately 1% in China, 5-20 % in Eastern Africa). Lactose intolerance presents with diverse symptoms, from the most typical (abdominal pain and distension, flatulence, diarrhea) to many others as nausea, vomiting, headache, poor concentration, severe tiredness, muscular and joint pain, etc. 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.

• W0106010402LACTOSE INTOLERANCE (POLYMORPHISMS)

• Numéro de lot
• Date d'expiration
• Date de fabrication
• Numéro de série
• Identification du logiciel