Trichomonas

Main information

  • Trade name:
  • Trichomonas IVDs
  • Class:
  • - IVD Class 3
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Trichomonas IVDs
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218478
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218478

Becton Dickinson Pty Ltd - Trichomonas IVDs

ARTG entry for

Medical Device Included - IVD Class 3

Sponsor

Becton Dickinson Pty Ltd

Postal Address

Locked Bag 3200,NORTH RYDE, NSW, 2113

Australia

ARTG Start Date

12/12/2013

Product category

Medical Device Class 3

Status

Active

Approval area

Conditions

- 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.

Manufacturers

Name

Address

Becton Dickinson and Company

7 Loveton Circle

Sparks, Maryland, 21152

United States Of America

Products

1. Trichomonas IVDs

Product Type

Effective date

12/12/2013

GMDN

CT822 Trichomonas IVDs

Intended purpose

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

Trichomonas

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.

Specific Conditions

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.

Public Summary

Page 1 of

Produced at 10.11.2017 at 10:16:46 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