Devices (same UDI-DI)
1
Certificates
0
Countries
5
Notified Bodies
0
Basic Information
- Primary DI
- D-NIPT17692GH
- Basic UDI-DI Code
- B-NIPT17692GH
- Reference
- NIPTIFY
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Celvia CC AS
Additional 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.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0106010399 | CHROMOSOMAL DISORDERS TESTS - OTHER |
Available In Countries
🇧🇬 Bulgaria
🇪🇪 Estonia
🇱🇹 Lithuania
🇱🇻 Latvia
🇵🇱 Poland
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