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Histology and Cytology ancillary IVDs

Access comprehensive regulatory information for Histology and Cytology ancillary IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Abbott Australasia Pty Ltd Diagnostic Division, manufactured by Abbott Laboratories (USA) in United States of America. The device registration started on May 17, 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 IIa
Class IIa
Histology and Cytology ancillary IVDs
Australia TGA ARTG Registered Device
Good Name: Abbott Australasia Pty Ltd Diagnostic Division - Histology and Cytology ancillary IVDs
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Intended Purpose

IVDs that are intended to be used alone or in combination with other IVDs to perform various histology and cytology-related tests and procedures

Device Classification
Risk Class
Class IIa
Product Type
IVD
ARTG Category
IVD
Registration Information
Start Date
May 17, 2022
Effective Date
May 17, 2022
Manufacturer
Country
United States of America
Address
4551 Great American Pkwy, Santa Clara, California, 95054