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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments
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Document Number K253318
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Document Parent Analyte Analyte Specialty Complexity Effective Date
Hangzhou Clongene Biotech Co., Ltd., Clungene RSV Antigen Rapid Test  (For use with nasopharyngeal swabs)
CR250611 K253318 Respiratory syncytial virus Virology MODERATE 02/03/2026

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