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General laboratoryware IVDs - ARTG 462427

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.

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Class I
ARTG 462427
Class I
General laboratoryware IVDs
ARTG ID: 462427
Good Name: Abbott Rapid Diagnostics Pty Ltd - General laboratoryware IVDs
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Intended Purpose

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.

Device Classification
Risk Class
Class I
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
462427
Start Date
September 20, 2024
Effective Date
September 20, 2024
Manufacturer
Country
Japan
Address
357 Matsuhidai Matsudo-shi, Chiba, 270-2214