We are pleased to announce the successful shipment of one of our molecular diagnostic products to the U.S. Food and Drug Administration (FDA): the Cyclospora cayetanensis DNA Detection Kit (150 reactions). This marks a significant milestone in our international collaboration efforts and highlights our commitment to high-quality diagnostics for global health.
About the Kit
The Cyclospora cayetanensis DNA Detection Kit is a real-time PCR-based tool designed for the specific identification of Cyclospora cayetanensis, a protozoan parasite responsible for cyclosporiasis, an intestinal illness associated with the ingestion of contaminated food or water. The disease is of particular concern in contexts of food safety and public health surveillance.
This kit includes 150 independent reactions, each enabling the amplification and detection of the parasite’s DNA with high specificity and sensitivity. Its design ensures reproducible results, fast turnaround time, and simple laboratory workflows, making it suitable for a wide range of clinical, research, and regulatory applications.
Manufactured Under Quality Standards
The product is developed and manufactured under a rigorous quality management system, certified according to:
- ISO 9001:2015 — for general quality management
- ISO 13485:2016 — for medical device quality assurance
These certifications ensure our kits meet global requirements for traceability, safety, and performance.
About the FDA
The Food and Drug Administration (FDA) is the United States federal agency responsible for safeguarding public health. Its core functions include:
- Reviewing and regulating medical products to ensure safety and efficacy
- Supporting innovation in diagnostics and therapeutics
- Providing accurate, science-based health information to the public
- Monitoring a wide range of products, from food and cosmetics to drugs and medical devices
- Contributing to national security through oversight of the medical and food supply chain
We are honored to have the opportunity for our product to be reviewed by such a respected institution.
Acknowledgments
We are grateful for the smooth and successful delivery process. Special thanks to Maria for facilitating this important shipment, and to the FDA for their tireless efforts in protecting public health and fostering innovation in life sciences.