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cobas NHP Negative Control Kit (cobas 5800/6800/8800) - PCR/NAT negative control IVD - ARTG 413915

Access comprehensive regulatory information for cobas NHP Negative Control Kit (cobas 5800/6800/8800) - PCR/NAT negative control IVD in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 413915 and sponsored by Roche Diagnostics Australia Pty Limited, manufactured by Roche Molecular Systems Inc in United States of America. The device registration started on July 21, 2023.

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 III
ARTG 413915
Class III
cobas NHP Negative Control Kit (cobas 5800/6800/8800) - PCR/NAT negative control IVD
ARTG ID: 413915
Good Name: Roche Diagnostics Australia Pty Limited - cobas NHP Negative Control Kit (cobas 5800/6800/8800) - PCR/NAT negative control IVD
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Intended Purpose

The cobasยฎ NHP Negative Control Kit is intended for use on the cobasยฎ systems as a negative batch control.

Device Classification
Risk Class
Class III
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
413915
Start Date
July 21, 2023
Effective Date
July 21, 2023
Manufacturer
Country
United States of America
Address
1080 US Highway 202, Branchburg, New Jersey, 08876