Constitutional chromosomal disorder IVDs

Riik: Austraalia

keel: inglise

Allikas: Department of Health (Therapeutic Goods Administration)

Osta kohe

Laadi alla Avaliku hindamisaruande (PAR)
19-07-2023

Saadav alates:

BGI Health (AU) Company Pty Ltd

Klass:

Class 3

Valmistatud:

BGI Europe A/S Symfonivej 34, Herlev, 2730 Denmark

Terapeutiline ala:

CT826 - Constitutional chromosomal disorder IVDs

Näidustused:

An IVD kit used to perform prenatal screening for trisomies of chromosomes 21, 18 and 13 (T21, T18 and T13) by analyzing the differences in the number of chromosomes 21, 18 and 13 in the cell-free fetal DNA in maternal plasma samples. This kit is used to prepare a sequencing DNA library of cell free DNA.

Volitamisolek:

A

Loa andmise kuupäev:

2023-05-16

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