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Specimen receptacle IVDs - ARTG 235827

Access comprehensive regulatory information for Specimen receptacle IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 235827 and sponsored by Interpath Services Pty Ltd, manufactured by Eastern Business Forms Inc in United States of America. The device registration started on April 07, 2015.

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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TGA ARTG Official Data
Class I
ARTG 235827
Class I
Specimen receptacle IVDs
ARTG ID: 235827
Good Name: Interpath Services Pty Ltd - Specimen receptacle IVDs
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Intended Purpose

This blood collection paper is intended for use by healthcare professionals in the collection and in-vitro storage of human blood. This filter paper card is used as a medium for the collection and transport of human capillary and venous blood specimen spots to a laboratory for test: • Blood may be collected from Neonates, Children, and Adults • The collected specimen is preserved in a dry form • The device is intended to be used by healthcare professionals only The collected specimen is then examined for providing information: • Concerning a physiological or pathological state, or • Concerning a congenital abnormality, or • To determine the safety and compatibility with potential recipients, or • To monitor therapeutic measures

Device Classification
Risk Class
Class I
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
235827
Start Date
April 07, 2015
Effective Date
April 07, 2015
Manufacturer
Country
United States of America
Address
530 Old Sulphur Springs Road, Greenville, SC, 29607