ARTG 352010Multiple-bacteria IVDs
ARTG ID: 352010 · Edwards Group Pty Ltd · SSI Diagnostica A/S · Class IIb · Started December 21, 2020
Good Name: Edwards Group Pty Ltd - Multiple-bacteria IVDs
- Risk Class
- Class IIb
- Product Type
- IVD
- ARTG Category
- IVD
- ARTG ID
- 352010
- Start Date
- December 21, 2020
- Effective Date
- December 21, 2020
- Country
- Denmark
- Address
- Herredsvejen 2, Hillerod, 3400
The ImmuView S. pneumoniae and L. pneumophila Test is intended for diagnosis of Streptococcus (S.) pneumoniae and Legionella (L.) pneumophila infections by detection of urinary antigens for either or both S. pneumoniae and L. pneumophila serogroup 1. The test is a lateral flow test also known as a lateral flow immunochromatographic assay.
Access comprehensive regulatory information for Multiple-bacteria IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 352010 and sponsored by Edwards Group Pty Ltd, manufactured by SSI Diagnostica A/S in Denmark. The device registration started on December 21, 2020.
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.