Australia flagARTG 307220

Clinical chemistry biological screening IVDs

ARTG ID: 307220 · Specialty Diagnostix Pty Ltd · Kova International · Class IIa · Started July 19, 2018

Good Name: Specialty Diagnostix Pty Ltd - Clinical chemistry biological screening IVDs

Device classification
Risk Class
Class IIa
Product Type
IVD
ARTG Category
IVD
Registration information
ARTG ID
307220
Start Date
July 19, 2018
Effective Date
July 19, 2018
Sponsor
Manufacturer
Country
United States of America
Address
7272 Chapman Avenue Suite B, Garden Grove, CA, 92841
Intended purpose

Intended for use in the clinical laboratory as a control for qualitative and semi quantitative procedures used in urinalysis.

About this record

Access comprehensive regulatory information for Clinical chemistry biological screening IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 307220 and sponsored by Specialty Diagnostix Pty Ltd, manufactured by Kova International in United States of America. The device registration started on July 19, 2018.

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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