ARTG 248314Bacterial infectious disease IVDs
ARTG ID: 248314 · Key Diagnostics Pty Ltd · Cortez Diagnostic Inc · Class IIa · Started July 16, 2015
Good Name: Key Diagnostics Pty Ltd - Bacterial infectious disease IVDs
- Risk Class
- Class IIa
- Product Type
- IVD
- ARTG Category
- IVD
- ARTG ID
- 248314
- Start Date
- July 16, 2015
- Effective Date
- July 16, 2015
- Country
- United States of America
- Address
- Suite 4 / 23961 Craftsman Road, Calabasas, CA, 91302
CT353 Bacterial infectious disease IVDs. Detection of bacterial antigen from stool samples, such as Helicobacter pylori antigen. Laboratory test only. Sample preparation device is for in-laboratory use only and not for sample transport.
Access comprehensive regulatory information for Bacterial infectious disease IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 248314 and sponsored by Key Diagnostics Pty Ltd, manufactured by Cortez Diagnostic Inc in United States of America. The device registration started on July 16, 2015.
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.