ARTG 474588Dried blood spot collection kit
ARTG ID: 474588 · Roche Diagnostics Australia Pty Limited · LabMate (Pty) Ltd · Class I · Started December 23, 2024
Good Name: Roche Diagnostics Australia Pty Limited - Dried blood spot collection kit
- Risk Class
- Class I
- Product Type
- Procedure Pack
- ARTG Category
- General-Export
- ARTG ID
- 474588
- Start Date
- December 23, 2024
- Effective Date
- December 23, 2024
- Country
- South Africa
- Address
- 11 South Cape Industrial Park 19 Leo Road, Diep River, Cape Town, 7800
A collection of devices and materials intended to be used by a healthcare professional at the point-of-care to collect a dried blood spot (DBS) specimen from capillary or venous blood, for subsequent diagnostic testing or screening. The kit typically includes a lancet and/or hypodermic needle with a syringe, capillary tube(s), a blood collection strip, dry blood collection card/filter paper card, and other items (e.g., alcohol prep pad, disposable lancet, gauze pad, bandage strip, and a container with a requisition form, for mailing to the laboratory). This is a single-use device.
Access comprehensive regulatory information for Dried blood spot collection kit in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 474588 and sponsored by Roche Diagnostics Australia Pty Limited, manufactured by LabMate (Pty) Ltd in South Africa. The device registration started on December 23, 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.