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General laboratoryware IVDs - ARTG 389350

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 389350 and sponsored by Abbott Australasia Pty Ltd Diagnostic Division, manufactured by Abbott Laboratories (USA) in United States of America. The device registration started on June 01, 2022.

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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TGA ARTG Official Data
Class I
ARTG 389350
Class I
General laboratoryware IVDs
ARTG ID: 389350
Good Name: Abbott Australasia Pty Ltd Diagnostic Division - General laboratoryware IVDs
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Intended Purpose

General Laboratoryware intended to be used specifically as an IVD in the testing of clinical specimens.

Device Classification
Risk Class
Class I
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
389350
Start Date
June 01, 2022
Effective Date
June 01, 2022
Manufacturer
Country
United States of America
Address
1921 Hurd Drive, Irving, Texas, 75038