Crystel

Main information

  • Trade name:
  • Crystel Kryptonite base and activator.
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Crystel Kryptonite base and activator.
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 213727
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

213727

MMRC Pty Ltd, Hospital Grade Disinfectants, with Non-Specific Claims, 'Chlorine dioxide'.

ARTG entry for

Other Therapeutic Good - Listed disinfectant

Sponsor

MMRC Pty Ltd

Postal Address

PO Box 4,ASHBURTON, VIC, 3147

Australia

ARTG Start Date

23/08/2013

Product category

Other Therapeutic Good

Status

Active

Approval area

Medical Devices

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. Crystel Kryptonite base and activator.

Product Type

Single Device Product

Effective date

23/08/2013

GMDN

9950 Disinfectant, hospital grade

Intended purpose

A concentrated two part activated liquid disinfectant 0.2?m filtered into sterile packaging for surface

disinfection of building and fitting surfaces within cleanrooms and grey areas. The Activator contains a

formulation of Sodium Chlorite and DI water. The Base is composed of Citric Acid and DI water. Both

activator and base products consist of 100 mls concentrate bottles. These two parts are intended to be

mixed with 4.8lts of water. Active ingredient is Chlorine Dioxide which is formed when the Activator and

Base are mixed.

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 11.11.2017 at 01:39:24 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