Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicine set out in the Schedule hereto:
Product: MDS QuickStream One-Step Pregnancy Test
Active Ingredients: Goat Anti-alpha-hCG Polyclonal Antibody 1.4Ág
Goat Anti-mouse Polyclonal Antibody 3.5Ág
Murine Anti-beta-hCG Monoclonal Antibody-Colloidal Gold Conjugate 1.4Ág
Dosage Form: Pregnancy test kit
New Zealand Sponsor: MDS Diagnostics Limited
Manufacturer: Phamatech, San Diego, California, United States of America
Dated this 20th day of November 2004.
DON MATHESON, Deputy Director-General, Public Health (pursuant to delegation given by the Minister of Health on 6 July 2001).