Summary for ARTG Entry:
Becton Dickinson Pty Ltd - Multiple-bacteria IVDs
ARTG entry for
Medical Device Included - IVD Class 3
Becton Dickinson Pty Ltd
Locked Bag 3200,NORTH RYDE, NSW, 2113
ARTG Start Date
Medical Device Class 3
- 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.
GeneOhm Sciences Canada Inc
2555 Boul du Parc Technologique
, Quebec, G1P 4S5
1. Multiple - Multiple-bacteria IVDs
CT774 Multiple-bacteria IVDs
An automated in vitro diagnostic test for the direct qualitative detection of enteric bacterial pathogens
including Salmonella spp., Campylobacter spp. (jejuni and coli), Shigellosis disease causing agents
Shigella spp. and Enteroinvasive E. coli (EIEC)] as well as Shiga-toxin producing E. coli from stool
specimens from symptomatic patients with suspected acute gastroenteritis, enteritis or colitis.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 05:57:39 AEDT
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