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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments
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1 to 10 of 14 Results
Document Number K212623
 
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Document Parent Analyte Analyte Specialty Complexity Effective Date
Proven Medical Testing LLC, Rapid Strep A Antigen Test  
CR260390 K212623 Streptococcus, group A Bacteriology WAIVED 06/05/2026
Healgen Life Science LLC, Healgen Rapid Check Strep A Antigen Test  
CR260369 K212623 Streptococcus, group A Bacteriology WAIVED 06/03/2026
Medline Industries, LP, Medline Strep A Rapid Antigen Strip Test  
CR260325 K212623 Streptococcus, group A Bacteriology WAIVED 05/18/2026
Jant Pharmacal Corporation, Accutest VALUPAK Strep A Test Strip  
CR260154 K212623 Streptococcus, group A Bacteriology WAIVED 04/10/2026
InBios International Inc., InBios Strep A RespiraDX Rapid Test  
CR250587 K212623 Streptococcus, group A Bacteriology WAIVED 10/16/2025
PHASE Diagnostics Inc., INDICAID Rapid Strep A Antigen Test  
CR250438 K212623 Streptococcus, group A Bacteriology WAIVED 08/15/2025
Germaine Laboratories Inc., StrepAim Pro Strep A Test  
CR250218 K212623 Streptococcus, group A Bacteriology WAIVED 04/25/2025
BTNX, Inc., Rapid Response Strep A Detection Strip  
CR250217 K212623 Streptococcus, group A Bacteriology WAIVED 04/25/2025
CLIAwaived Inc, Strep A Plus Rapid Test Kit  
CR250216 K212623 Streptococcus, group A Bacteriology WAIVED 04/25/2025
Medical Disposables, MD Rapid Strep A Antigen Test  
CR250149 K212623 Streptococcus, group A Bacteriology WAIVED 04/14/2025

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