LV4825

Organization name

SISTEMAS GENOMICOS. S.L.

SRN

ES-MF-000022949

Manufacturer status

Active

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• CW010

  EUDAMED did not publish a description for this code.

Primary placement in Spain; available across 1 country total.

Placed on the market in Spain; per-country availability dates not published.

Trade name

not provided

UDI-DI code

08436566763196

Basic UDI-DI

B-08436566763196

Reference / catalog number

LV4825

Issuing entity

GS1

Risk category

IVDD — Annex II List B

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

Software destinado a la evaluación del riesgo de la trisomía del par 21 mediante secuenciación masiva de ADN, a partir de datos provenientes de la secuenciación de genoma completo a baja cobertura a partir de ADN fetal circulante: También permite la evaluación de aneuploidías de los cromosomas 13, 18 y 23 y para detectar CNV’s de más de 6 megabases (Mb) asociados los varios síndromes de microdeleción a partir de datos provenientes de la secuenciación de genoma completo a baja cobertura a partir de ADN fetal circulante

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W02050192NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE

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