3.151.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-84295773151WMFN

Basic UDI-DI

B-84295773151WMFN

Reference / catalog number

3.151.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

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.

Additional information URL

https://www.operondx.com/

Clinical sizes

No clinical sizes registered for this device.

• W0106010199MONOGENETIC DISORDERS TESTS - OTHER

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