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Constitutional chromosomal disorder IVDs

Access comprehensive regulatory information for Constitutional chromosomal disorder IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Abacus dx Pty Ltd, manufactured by Devyser AB in Sweden. The device registration started on June 04, 2024.

This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.

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Class IIb
Class IIb
Constitutional chromosomal disorder IVDs
Australia TGA ARTG Registered Device
Good Name: Abacus dx Pty Ltd - Constitutional chromosomal disorder IVDs
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Intended Purpose

Qualitative in vitro diagnostic assay as an aid in diagnosis of aneuploidies in prenatal samples (chorionic villus (CV), amniotic fluid (AF)) such as Down, Edwards, Patau, Klinefelter Turner, XXY and Triple X syndrome.

Device Classification
Risk Class
Class IIb
Product Type
IVD
ARTG Category
IVD
Registration Information
Start Date
June 04, 2024
Effective Date
June 04, 2024
Manufacturer
Country
Sweden
Address
Instrumentvagen 19, Hagersten, 126 53