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Clinical Chemistry IVDs

Access comprehensive regulatory information for Clinical Chemistry IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Abbott Rapid Diagnostics Pty Ltd, manufactured by Abbott Diagnostics Medical Co Ltd in Japan. The device registration started on December 06, 2019.

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
Class I
Clinical Chemistry IVDs
Australia TGA ARTG Registered Device
Good Name: Abbott Rapid Diagnostics Pty Ltd - Clinical Chemistry IVDs
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Intended Purpose

Rapid immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) for early detection of pregnancy.

Device Classification
Risk Class
Class I
Product Type
IVD
ARTG Category
IVD-Export
Registration Information
Start Date
December 06, 2019
Effective Date
December 06, 2019
Manufacturer
Country
Japan
Address
357 Matsuhidai Matsudo-shi, Chiba, 270-2214