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FDA grants CLIA waiver to dry eye diagnosis test
Rapid Pathogen Screening Inc. (RPS) has received a Clinical Laboratory Improvement Amendments (CLIA) waiver from the FDA for its rapid, disposable, in-office test (InflammaDry) to aid in the diagnosis of dry eye disease.
Sarasota, FL-Rapid Pathogen Screening Inc. (RPS) has received a Clinical Laboratory Improvement Amendments (CLIA) waiver from the FDA for its rapid, disposable, in-office test (InflammaDry) to aid in the diagnosis of dry eye disease.
Obtaining the CLIA waiver, in addition to its FDA 510(k) clearance, enables the test to be used throughout the United States-an expansion from its current use internationally.
“The millions of patients who struggle with dry eye disease deserve an accurate diagnosis to facilitate more timely and appropriate management of their disease,” said Robert Sambursky, MD, chief executive officer, president, and chairman of RPS. “The receipt of (the test’s) CLIA waiver is another significant milestone for the RPS family of products as we work to bring accurate diagnosis of ocular, inflammatory, and infectious diseases to clinicians and patients globally.”
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