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Candida IVDs - ARTG 407591

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.

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Class IIb
ARTG 407591
Class IIb
Candida IVDs
ARTG ID: 407591
Good Name: Integrated Sciences Pty Ltd - Candida IVDs
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Intended Purpose

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

Device Classification
Risk Class
Class IIb
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
407591
Start Date
April 13, 2023
Effective Date
April 13, 2023
Manufacturer
Country
South Korea
Address
Taewon Bldg 91, Ogeum-ro Songpa-gu, Seoul, 05548