Procleix

Main information

  • Trade name:
  • Procleix Ultrio Plus Assay - HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
  • Class:
  • - IVD Class 4
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Procleix Ultrio Plus Assay - HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222720
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222720

Grifols Australia Pty Ltd - Procleix Ultrio Plus Assay - HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid

IVD, kit, nucleic acid technique (NAT)

ARTG entry for

Medical Device Included - IVD Class 4

Sponsor

Grifols Australia Pty Ltd

Postal Address

Unit 5/80 Fairbank Road,CLAYTON SOUTH, VIC, 3169

Australia

ARTG Start Date

23/04/2014

Product category

Medical Device Class 4

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

Hologic Inc

10210 Genetic Center Drive

San Diego, CA, 92121

United States Of America

Products

1. Procleix Ultrio Plus Assay - HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid

technique (NAT)

Product Type

Effective date

23/04/2014

GMDN

48216 HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Functional description

The Procleix Ultrio Plus assay is a qualitative in vitro nucleic acid amplification test for the detection of

HIV-1 RNA, HCV RNA, and /or HBV DNA in plasma and serum samples from human donors, tested

individually. It is also intended for use in testing plasma and serum to screen organ and tissue donors,

including cadaveric donors. It is not intended for use on samples of cord blood nor for use as an aid in

diagnosis.

Intended purpose

The Procleix Ultrio Plus assay is a qualitative in vitro nucleic acid amplification test for the detection of

human immunodeficiency virus type 1 (HIV-1) RNA, hepatitis C virus (HCV) RNA, and /or hepatitis B virus

(HBV) DNA in plasma and serum samples from human donors, tested individually. it is also intended for

use in testing plasma and serum to screen orand and tissue donors, including cadaveric (non

heart-beating) donors. It is not intended for use on samples of cord blood. The assay is not intended for

use as an aid in diagnosis. The assay is intended for use in testing individual blood specimens from living

or cadaveric (non-heart-beating) donors.

Variant information

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 22.11.2017 at 11:23:58 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.