Ovu-Trac® - Ovulation Predictor Kit - Our Quality Commitment to You

An Ovulation Predictor Kit That You Can Rely On

Created in 1996, the Ovu-Trac® Ovulation Predictor Kit is an educational tool specifically designed to assist women with identifying fertility and ovulation in the comfort of their own homes. Since that time tens of thousands of Canadian women have successfully used the Ovu-Trac® to assist them with their conception goals. All Ovu-Trac® Ovulation Predictor Kit components meet the quality standards that OvumOptics has put in place to meet the medical device regulations of both Health Canada and the Food and Drug Administration. These stringent parameters ensure our customers receive the highest quality product to give them the most accurate and reliable test results.

And this commitment to quality underlies everything we do. OvumOptics mission is to provide women and couples with fertility awareness products to assist them with achieving pregnancy safely and effectively. This quality commitment is not just words, it is incorporated into everything we do at an administrative, service and manufacturing level.

The Ovu-Trac® Ovulation Predictor Kit is considered an in-vitro diagnostic medical device (ivdd) by both Health Canada and the Food and Drug Administration in the United States. Both government agencies have stringent regulations that medical device manufacturers and distributors must meet to legally sell their products to the public. OvumOptics, the company that manufactures and distributes the Ovu-Trac®, has a comprehensive Quality Management System in place that is ISO 13485:2003 Canadian Medical Devices Conformity Assessment System (CMDCAS) registered. To ensure OvumOptics meets these regulatory requirements we are third party audited by the Quality Management Institute (CERT-0012168 1046839). OvumOptics also holds a valid Class II Medical Device License for the Ovu-Trac® Ovulation Predictor Kit in Canada (#68422). In 2008 OvumOptics met all of the regulatory requirements to sell the Ovu-Trac® legally into the United States.

There are many products being offered on-line that do not meet the medical device regulations that are in place to protect the consumer. When considering which ovulation predictor kit to purchase ensure the manufacturer meets these regulatory requirements to legally sell their product to you. If they cannot produce their medical device documents or establishment license, look for another product.

You can feel confident that the Ovu-Trac® Ovulation Predictor Kit meets all of the regulatory requirements and is your best choice for in-home ovulation prediction.

Related Links:

Ovulation Predictor Kit - e-store
Ovulation Predictor Kit - FAQs
Ovulation Predictor Kit - Testimonials
Ovulation Predictor Tests - What's in the Kit?
Ovulation Predictor Kits - Comparison
Ovulation Predictor Kit - Ovulation, Science & Saliva