ZEUS SCIENTIFIC IS DEDICATED TO DELIVERING THE HIGHEST QUALITY PRODUCTS TO THE DIAGNOSTIC MARKETPLACE.
On a worldwide basis, ZEUS Scientific conforms to applicable regulatory and international standards for in vitro diagnostic device manufacturers, most notably:
- The Food and Drug Administration (FDA) Code of Federal Regulation 21 CFR 820
This quality system regulation includes requirements related to the designing, manufacturing, packaging, labeling, storing, installing, and servicing of medical devices intended for human use. It is intended to ensure that finished devices will be safe and effective and otherwise in compliance with the Federal Food, Drug, and Cosmetic Act and establishes basic requirements applicable to manufacturers of finished medical devices.
- 98/79 EC Directive
This directive is related to the manufacture of in vitro diagnostic medical devices. Compliance to this directive enables ZEUS Scientific to apply a CE mark to in vitro medical devices that are sold in the European Union.
ZEUS Scientific prides itself on the ability to develop and obtain appropriate regulatory clearances for products utilizing different technologies and different disease states. Since the company first started doing business, ZEUS Scientific has obtained over 130 product clearances from the FDA and the majority of the products also carry CE marking. In 1987 ZEUS Scientific was the first company to develop, receive the appropriate regulatory clearance and bring to market a serological assay to test for Lyme disease – a condition with high prevalence in the local community where ZEUS Scientific is located.