Candida IVDs
ARTG ID: 407591 · Integrated Sciences Pty Ltd · Seegene Inc · Class IIb · Started April 13, 2023
Good Name: Integrated Sciences Pty Ltd - Candida IVDs
- Risk Class
- Class IIb
- Product Type
- IVD
- ARTG Category
- IVD
- ARTG ID
- 407591
- Start Date
- April 13, 2023
- Effective Date
- April 13, 2023
- Name
- Seegene Inc
- Country
- South Korea
- Address
- Taewon Bldg 91, Ogeum-ro Songpa-gu, Seoul, 05548
Allplex TM Candidiasis Assay is a qualitative in vitro test for single or multiple detection of C.albicans (CA), C.krusei (CK), C.glabrata (CG), C.dubliniensis (CD), C.parapsilosis (CP) C.tropicalis (CTp) and C.lusitaniae (CL) in diagnostic specimens
Access comprehensive regulatory information for Candida IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 407591 and sponsored by Integrated Sciences Pty Ltd, manufactured by Seegene Inc in South Korea. The device registration started on April 13, 2023.
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.