The following is a list of analytes that are used in laboratory test systems that have been
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.