ARTG 351639Streptococcus IVDs
ARTG ID: 351639 · Edwards Group Pty Ltd · SSI Diagnostica A/S · Class IIb · Started December 11, 2020
Good Name: Edwards Group Pty Ltd - Streptococcus IVDs
- Risk Class
- Class IIb
- Product Type
- IVD
- ARTG Category
- IVD
- ARTG ID
- 351639
- Start Date
- December 11, 2020
- Effective Date
- December 11, 2020
- Country
- Denmark
- Address
- Herredsvejen 2, Hillerod, 3400
The ImmuView® S. pneumoniae Antigen Test is intended for diagnosis of Streptococcus pneumoniae infections by detection of urinary antigens or antigens in cerebrospinal fluid (CSF). The test is a lateral flow test also known as a lateral flow immunochromatographic assay.
Access comprehensive regulatory information for Streptococcus IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 351639 and sponsored by Edwards Group Pty Ltd, manufactured by SSI Diagnostica A/S in Denmark. The device registration started on December 11, 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.