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:
  • 219516
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219516

Bio-Rad Laboratories Pty Ltd - Specimen receptacle IVDs

ARTG entry for

Medical Device Included - IVD Class 1

Sponsor

Bio-Rad Laboratories Pty Ltd

Postal Address

PO Box 752,GLADESVILLE, NSW, 1675

Australia

ARTG Start Date

23/01/2014

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

Bio-Rad

3 Boulevarde Raymond Poincare

, MARNES-LA-COQUETTE, 92430

France

Products

1. Specimen receptacle IVDs

Product Type

Effective date

23/01/2014

GMDN

CT936 Specimen receptacle IVDs

Intended purpose

Intended to be used for the collection, containment, preservation and/or transport of all clinical specimens

for analysis.

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 07:19:42 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

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