Australia flagARTG 295864

Multiple clinical chemistry constituent IVDs

ARTG ID: 295864 · Revvity Pty Ltd · Wallac Oy · Class IIa · Started November 03, 2017

Good Name: Revvity Pty Ltd - Multiple clinical chemistry constituent IVDs

Device classification
Risk Class
Class IIa
Product Type
IVD
ARTG Category
IVD
Registration information
ARTG ID
295864
Start Date
November 03, 2017
Effective Date
November 03, 2017
Sponsor
Manufacturer
Country
Finland
Address
Mustionkatu 6, Turku, FI-20750
Intended purpose

The assay is intended for the quantitative measurement of the activity of the enzymes acid-β-glucocerebrosidase (ABG), acid-sphingomyelinase (ASM), acid α glucosidase (GAA), β galactocerebrosidase (GALC), α-galactosidase A (GLA) and α-L-iduronidase (IDUA) in dried blood spots (DBS).

About this record

Access comprehensive regulatory information for Multiple clinical chemistry constituent IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 295864 and sponsored by Revvity Pty Ltd, manufactured by Wallac Oy in Finland. The device registration started on November 03, 2017.

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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