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Specimen receptacle IVDs - ARTG 483966

Access comprehensive regulatory information for Specimen receptacle IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 483966 and sponsored by Emergo Asia Pacific Pty Ltd T/a Emergo Australia, manufactured by Precision for Medicine Inc in United States of America. The device registration started on March 25, 2025.

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 483966
Class I
Specimen receptacle IVDs
ARTG ID: 483966
Good Name: Emergo Asia Pacific Pty Ltd T/a Emergo Australia - Specimen receptacle IVDs
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Intended Purpose

The AAV5 NAb Test Specimen Collection Kit is intended for use in the non-invasive collection and transport of serum samples. Samples collected are to be transported to Precision for Medicine for testing using the AAV5 NAb Test.

Device Classification
Risk Class
Class I
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
483966
Start Date
March 25, 2025
Effective Date
March 25, 2025
Manufacturer
Country
United States of America
Address
8440 Broadband Drive Frederick, MD, 21701