Australia TGA ARTG recordMultiple clinical chemistry constituent IVDs
Australia TGA ARTG Registered Device · Revvity Pty Ltd · Wallac Oy · Class IIa · Started November 03, 2017
Good Name: Revvity Pty Ltd - Multiple clinical chemistry constituent IVDs
- Risk Class
- Class IIa
- Product Type
- IVD
- ARTG Category
- IVD
- Start Date
- November 03, 2017
- Effective Date
- November 03, 2017
- Name
- Revvity Pty Ltd
- Name
- Wallac Oy
- Country
- Finland
- Address
- Mustionkatu 6, Turku, FI-20750
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).
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 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.