Abstract
Today, the U.S. Food and Drug Administration announced it is allowing the use of the Binx Health IO CT/NG Assay at point-of-care settings, such as in physician offices, community-based clinics, urgent care settings, outpatient health care facilities and other patient care settings, operating under a CLIA Certificate of Waiver, Certificate of Compliance or Certificate of Accreditation. This action is the result of the FDA granting a waiver under the Clinical Laboratory Improvement Amendments of 1988 (CLIA") for the Binx Health IO CT/NG Assay."
Key Data
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Publication Date30 March 2021
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Primary AuthorU.S. Food and Drug Administration
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SourceFDA
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LanguageEnglish
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