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therascreen KRAS RGQ PCR Kit (Cat No. 870081) - Acquired genetic alteration IVDs

Australia TGA ARTG Registered Device · Qiagen Pty Ltd · Qiagen GmbH · Class IIb · Started March 30, 2022

Good Name: Qiagen Pty Ltd - therascreen KRAS RGQ PCR Kit (Cat No. 870081) - Acquired genetic alteration IVDs

Device classification
Risk Class
Class IIb
Product Type
IVD
ARTG Category
IVD
Registration information
Start Date
March 30, 2022
Effective Date
March 30, 2022
Sponsor
Manufacturer
Country
Germany
Address
Qiagen Str 1, Hilden, 40724
Intended purpose

IVDs intended for the detection of somatic mutations in oncogenes using nucleic acids extracted from human specimens to guide targeted therapy

About this record

Access comprehensive regulatory information for therascreen KRAS RGQ PCR Kit (Cat No. 870081) - Acquired genetic alteration IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Qiagen Pty Ltd, manufactured by Qiagen GmbH in Germany. The device registration started on March 30, 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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