Australia TGA ARTG recordClinical chemistry enzyme IVDs
Australia TGA ARTG Registered Device · Intermed Medical Pty Ltd · Abbott Diagnostics Scarborough Inc also d/b/a Alere Scarborough Inc · Class IIa · Started June 20, 2016
Good Name: Intermed Medical Pty Ltd - Clinical chemistry enzyme IVDs
- Risk Class
- Class IIa
- Product Type
- IVD
- ARTG Category
- IVD
- Start Date
- June 20, 2016
- Effective Date
- June 20, 2016
- Country
- United States of America
- Address
- 10 Southgate Road, Scarborough, Maine, 04074
The WOUNDCHEK™ range of products are in vitro chromatographic test for the qualitative assessment of inflammatory protease activity directly from a wound fluid swab sample collected from a chronic or symptomatic wound. The WOUNDCHEK™ range of products are intended for diagnostic use, at the point of care, as an aid in the healthcare professional’s assessment of whether a wound may be non-healing due to the presence of elevated protease activity.
Access comprehensive regulatory information for Clinical chemistry enzyme IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Intermed Medical Pty Ltd, manufactured by Abbott Diagnostics Scarborough Inc also d/b/a Alere Scarborough Inc in United States of America. The device registration started on June 20, 2016.
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.