DiaSys Diagnostics Receives FDA 510(k) Clearance for Procalcitonin FS Assay; Vidan Diagnostics Named Exclusive U.S. Distributor

SAN ANTONIO, Texas, May 29, 2025 – Vidan Diagnostics, announced its partner DiaSys Diagnostic Systems GmbH, a global manufacturer of high-quality diagnostic reagents and systems has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Procalcitonin FS Assay. This milestone enables the assay’s clinical use in the United States for aiding in the assessment of patients with suspected bacterial infections and sepsis.  As part of its strategic expansion into the U.S. market, DiaSys has partnered with Vidan Diagnostics, which holds exclusive distribution rights for the Procalcitonin FS assay in the United States.

Diasys Procalcitonin FS Assay

Diasys’ newly cleared Procalcitonin FS Assay represents a significant advancement in procalcitonin testing.  It provides clinicians with a rapid and highly sensitive solution for the measurement of PCT in conjunction with other laboratory findings and clinical assessments aids in the risk assessment of critically ill patients on their first day of ICU admission for progression to severe sepsis and septic schock.  “We are honored to be the exclusive distributor of the Procalcitonin FS Assay in the U.S.  This partnership with DiaSys allows us to bring a high-performance diagnostic test to healthcare providers across the country.” said Gilbert Mejia, CEO of Vidan Diagnostics. “Vidan Diagnostics enters the procalcitonin testing market, providing laboratories with a competitive new option to meet growing diagnostic testing demands.” Mejia added.

Key features of the Procalcitonin FS Assay

• FDA 510(k) cleared for clinical use in the U.S.
• High analytical sensitivity and specificity
• Rapid turnaround time for timely clinical evaluation
• Liquid-stable, ready-to-use reagent
• Broad compatibility with automated clinical chemistry analyzers

Vidan Diagnostics

Founded in 2018, Vidan Diagnostics is a supplier of medical diagnostic products.  It is focused on medical devices and reagents used for diagnosing and monitoring patients with conditions of diabetes, sepsis, anemia, heart disease and stroke.  Vidan Diagnostics is dedicated to delivering proven and innovative products to all people in all places, in all aspects and stages of life with integrity and reliability.  The company is headquartered in San Antonio, Texas.