ARTG 462427General laboratoryware IVDs
ARTG ID: 462427 · Abbott Rapid Diagnostics Pty Ltd · Abbott Diagnostics Medical Co Ltd · Class I · Started September 20, 2024
Good Name: Abbott Rapid Diagnostics Pty Ltd - General laboratoryware IVDs
- Risk Class
- Class I
- Product Type
- IVD
- ARTG Category
- IVD
- ARTG ID
- 462427
- Start Date
- September 20, 2024
- Effective Date
- September 20, 2024
- Country
- Japan
- Address
- 357 Matsuhidai Matsudo-shi, Chiba, 270-2214
Chase Buffer is intended for use with Determine in vitro diagnostic rapid test devices. Chase Buffer enables the migration of the specimen and conjugate through the test device when testing whole blood specimens. It is specifically formulated and optimised to ensure the Determine test performs correctly and controls assay flow. It is for professional use and near-patient testing, not for self-testing.
Access comprehensive regulatory information for General laboratoryware IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 462427 and sponsored by Abbott Rapid Diagnostics Pty Ltd, manufactured by Abbott Diagnostics Medical Co Ltd in Japan. The device registration started on September 20, 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.