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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments
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Document Number CW250004
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Document Parent Analyte Analyte Specialty Complexity Effective Date
Visby Medical, Inc., Visby Medical Men's Sexual Health Test  (For use with male urine specimens)
CW250004 K251501 Chlamydia Bacteriology WAIVED 10/01/2025
Visby Medical, Inc., Visby Medical Men's Sexual Health Test  (For use with male urine specimens)
CW250004 K251501 Neisseria gonorrhoeae Bacteriology WAIVED 10/01/2025

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