3.135.XXX.YY.ZZZ

Organization name

OPERON, S.A.

SRN

ES-MF-000004790

Manufacturer status

Active

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• CW265

  The denaturation solution contains < 2% NaOH

Primary placement in Spain; available across 5 countries total.

Trade name

not provided

UDI-DI code

D-84295773135WPG2

Basic UDI-DI

B-84295773135WPG2

Reference / catalog number

3.135.XXX.YY.ZZZ

Issuing entity

EUDAMED

Risk category

IVDD — General

Applicable legislation

IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

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.

Additional information URL

https://www.operondx.com/

Clinical sizes

No clinical sizes registered for this device.

• W0106010402LACTOSE INTOLERANCE (POLYMORPHISMS)

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