Australia flagARTG 472765

Bacterial infectious disease IVDs

ARTG ID: 472765 · Abmed Medical Technology Pty Ltd · Anhui Deepblue Medical Technology Co Ltd · Class IIa · Started December 12, 2024

Good Name: Abmed Medical Technology Pty Ltd - Bacterial infectious disease IVDs

Device classification
Risk Class
Class IIa
Product Type
IVD
ARTG Category
IVD
Registration information
ARTG ID
472765
Start Date
December 12, 2024
Effective Date
December 12, 2024
Sponsor
Manufacturer
Country
China
Address
No 777 Jimingshan Road High-Tech Development Zone, Hefei, Anhui, 230088
Intended purpose

This product is used for in vitro qualitative detection of antibodies to H.pylori in whole blood, serum or plasma to aid in the diagnosis of H.pylori infection. The H.Pylori Antibody Test Kit is a rapid chromatographic immunoassay for the qualitative detection of antibodies to H. pylori in whole blood,serum or plasma to aid in the diagnosis of H. pylori infection.

About this record

Access comprehensive regulatory information for Bacterial infectious disease IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 472765 and sponsored by Abmed Medical Technology Pty Ltd, manufactured by Anhui Deepblue Medical Technology Co Ltd in China. The device registration started on December 12, 2024.

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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