Summary for ARTG Entry:
R-Biopharm Pty Ltd - Instrument/analyser IVDs
ARTG entry for
Medical Device Included - IVD Class 1
R-Biopharm Pty Ltd
PO Box 2011,TAREN POINT, NSW, 2229
ARTG Start Date
Medical Device Class 1
- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,
Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations
2002 for relevant information.
- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal
offence; and civil penalties may apply.
Eiken Chemical Co Ltd
Taito-Ku, Tokyo, 110-8408
1. Instrument/analyser IVDs
CT943 Instrument/analyser IVDs
Instruments used for the measurement of faecal occult blood. Measurement of haemoglobin in faeces is
an effective means of screening for early detection and treatment of colon cancer and other lower
digestive tract illnesses that are accompanied by haemorrhaging.
No Specific Conditions included on Record
© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior
written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.
Page 1 of
Produced at 01.12.2017 at 07:13:28 AEDT
This is not an ARTG Certificate document.
The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.
Visit www.tga.gov.au for contact information