Specimen

Main information

  • Trade name:
  • Specimen receptacle IVDs
  • Class:
  • - IVD Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Specimen receptacle IVDs
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217780
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217780

Medical Systems International Pty Ltd - Specimen receptacle IVDs

ARTG entry for

Medical Device Included - IVD Class 1

Sponsor

Medical Systems International Pty Ltd

Postal Address

24 Alexander Street,COLLAROY, NSW, 2097

Australia

ARTG Start Date

27/11/2013

Product category

Medical Device Class 1

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

Medical Systems International Pty Ltd

24 Alexander Street

COLLAROY, NSW, 2097

Australia

Products

1. Specimen receptacle IVDs

Product Type

Effective date

27/11/2013

GMDN

CT936 Specimen receptacle IVDs

Intended purpose

The kit is for the self?collection and transport of cervical cells to a laboratory for in vitro diagnostic (IVD)

testing.

The test results are reported directly back to the patient's medical practitioner or healthcare professional.

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 01:02:13 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

30-5-2018

Procleix West Nile Virus (WNV) Assay

Procleix West Nile Virus (WNV) Assay

Product approval information is indicated for the qualitative detection of West Nile Virus (WNV) RNA in plasma specimens from individual human donors, including volunteer donors of whole blood and blood components, and other living donors.

FDA - U.S. Food and Drug Administration

There are no news related to this product.