Australia TGA ARTG recordSpecimen receptacle IVDs
Australia TGA ARTG Registered Device · Emergo Asia Pacific Pty Ltd T/a Emergo Australia · Genomic Health Inc · Class I · Started August 07, 2014
Good Name: Emergo Asia Pacific Pty Ltd T/a Emergo Australia - Specimen receptacle IVDs
- Risk Class
- Class I
- Product Type
- IVD
- ARTG Category
- IVD
- Start Date
- August 07, 2014
- Effective Date
- August 07, 2014
- Country
- United States of America
- Address
- 301 Penobscot Drive, Redwood City, CA, 94063
The purpose of the Oncotype DX kit is to transport formalin fixed paraffin embedded tumor (FFPET) samples to Genomic Health Inc. in the United States for processing. FFPET samples are non-biohazardous, non-infectious, non-liquid, and stable at room temperature. Users have the option of providing FFPET samples as blocks or as block sections added to a slide. The kit contains zip closure bags, a foam insert, a slide mailer (for samples provided as block sections), and a gel ice pack (for samples provided as blocks).
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 sponsored by Emergo Asia Pacific Pty Ltd T/a Emergo Australia, manufactured by Genomic Health Inc in United States of America. The device registration started on August 07, 2014.
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.