NIPTIFY

Organization name

Celvia CC AS

SRN

EE-MF-000045569

Manufacturer status

Active

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• CW263

  Excempt human specimen

Primary placement in Estonia; available across 5 countries total.

Trade name

not provided

UDI-DI code

D-NIPT17692GH

Basic UDI-DI

B-NIPT17692GH

Reference / catalog number

NIPTIFY

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

NIPTIFY test by Focus Plus method assesses the risk of the existence of fetal chromosomal abnormalities based on a maternal blood sample from the 10+ week of gestation. The test detects frequently occurring trisomies of chromosomes 13 (Patau syndrome), 18 (Edwards syndrome), 21 (Down syndrome). Test also evaluates the absence of the second X-chromosome in female fetuses (Turner syndrome), detects 22q11 microdeletion (DiGeorge syndrome) and determines the chromosomal sex of the fetus.

Additional information URL

https://www.niptify.com/

Clinical sizes

No clinical sizes registered for this device.

• W0106010399CHROMOSOMAL DISORDERS TESTS - OTHER

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