Australia TGA ARTG recordSevere acute respiratory syndrome-associated coronavirus IVDs
Australia TGA ARTG Registered Device · Biocelect Pty Ltd · SD Biosensor Inc · Class IIb · Started October 01, 2020
Good Name: Biocelect Pty Ltd - Severe acute respiratory syndrome-associated coronavirus IVDs
- Risk Class
- Class IIb
- Product Type
- IVD
- ARTG Category
- IVD
- Start Date
- October 01, 2020
- Effective Date
- December 06, 2022
- Name
- SD Biosensor Inc
- Country
- South Korea
- Address
- Digitial Empire Building C-4&5th Floor, 16 Deogyeong-daero 1556beon-gil, Yeongtong-gu Suwon-Si, Gyeonggi-do, 16690
Intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19 from symptomatic individuals for point of care by trained health professionals (nasopharyngeal and nasal swab).
Access comprehensive regulatory information for Severe acute respiratory syndrome-associated coronavirus IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Biocelect Pty Ltd, manufactured by SD Biosensor Inc in South Korea. The device registration started on October 01, 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.