Summary for ARTG Entry:
Becton Dickinson Pty Ltd - Trichomonas 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.
Becton Dickinson and Company
7 Loveton Circle
Sparks, Maryland, 21152
United States Of America
1. Trichomonas IVDs
CT822 Trichomonas IVDs
The BD ProbeTec™ Trichomonas vaginalis (TV) Qx Amplified DNA Assay, when tested with the BD
Viper™ System in
Extracted Mode, uses Strand Displacement Amplification technology for the direct, qualitative detection of
vaginalis DNA in clinician-collected female endocervical swab specimens, patient-collected vaginal swab
specimens (in a
clinical setting), and female urine specimens. The assay is indicated for use with asymptomatic and
symptomatic females to
aid in the diagnosis of trichomoniasis.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 10:16:46 AEDT
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