Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments
  • Print
  • Share
  • E-mail
-
1 to 10 of 25 Results
Document Number K233417
 
 1 
 2 
 3 
 > 
Results per Page

New Searchexport reports to excelExport to Excel | HelpHelp
Document Parent Analyte Analyte Specialty Complexity Effective Date
Mobilab Medical Innovatives Inc, Mobilab Fentanyl Urine Test Cassette  
CR250741 K233417 Fentanyl Toxicology / TDM WAIVED 01/30/2026
Home Health US Incorporated, One Step Fentanyl Urine Test Cassette  
CR250465 K233417 Fentanyl Toxicology / TDM WAIVED 08/20/2025
ABOUND Diagnostics, Inc., CHOSEN Fentanyl Rapid Urine Test Cassette  
CR250195 K233417 Fentanyl Toxicology / TDM WAIVED 05/06/2025
ABOUND Diagnostics, Inc., CHOSEN Fentanyl Urine Rapid Test Cassette  
CR250195 K233417 Fentanyl Toxicology / TDM WAIVED 05/06/2025
Genabio Diagnostics Inc., GenaCheck™ Fentanyl Urine Test Cassette  
CR240193 K233417 Fentanyl Toxicology / TDM WAIVED 05/08/2024
Genabio Diagnostics Inc., GenaCheck™ Fentanyl Urine Home-Use Test Cassette  
CR240193 K233417 Fentanyl Toxicology / TDM WAIVED 05/08/2024
Germaine Laboratories, Inc., AimScreen Fentanyl Test  
CR240103 K233417 Fentanyl Toxicology / TDM WAIVED 03/28/2024
ACRO BIOTECH Inc., ACRO Fentanyl Urine Test  
CR240101 K233417 Fentanyl Toxicology / TDM WAIVED 03/19/2024
ACRO BIOTECH Inc., ACRO Fentanyl Urine Test Cassette  
CR240101 K233417 Fentanyl Toxicology / TDM WAIVED 03/19/2024
Aceso Laboratories, Inc. Atida Fentanyl Test  
CR240130 K233417 Fentanyl Toxicology / TDM WAIVED 03/08/2024

-
-