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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments - Currently Waived Analytes

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The following is a list of analytes that are used in laboratory test systems that have been "waived". Under the current process, waiver may be granted to: 1) any test listed in the regulation, 2) any test system for which the manufacturer or producer applies for waiver if that test meets the statutory criteria and the manufacturer provides scientifically valid data verifying that the waiver criteria have been met, and 3) test systems cleared by the FDA for home use. The waived analytes below are linked to waived test systems. Select an analyte of interest below to view test systems that are waived for the analyte.
 
 
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Show All Analytes Download Files | More About CLIA
Analyte Name
UREA (BUN)
URIC ACID
URINARY PROTEIN, QUALITATIVE
URINE DIPSTICK OR TABLET ANALYTES, NONAUTOMATED
URINE HCG BY VISUAL COLOR COMPARISON TESTS
URINE QUALITATIVE DIPSTICK ASCORBIC ACID
URINE QUALITATIVE DIPSTICK BILIRUBIN
URINE QUALITATIVE DIPSTICK BLOOD
URINE QUALITATIVE DIPSTICK CHEMISTRIES
URINE QUALITATIVE DIPSTICK CREATININE
URINE QUALITATIVE DIPSTICK GLUCOSE
URINE QUALITATIVE DIPSTICK KETONE
URINE QUALITATIVE DIPSTICK LEUKOCYTES
URINE QUALITATIVE DIPSTICK NITRITE
URINE QUALITATIVE DIPSTICK PH
URINE QUALITATIVE DIPSTICK PROTEIN
URINE QUALITATIVE DIPSTICK SPECIFIC GRAVITY
URINE QUALITATIVE DIPSTICK UROBILINOGEN
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