All CLIA-waived tests
CLIA-waived analyte
hgb, single analyte inst. w/self-cont.: CLIA-waived test status.
HGB, SINGLE ANALYTE INST. W/SELF-CONT. appears on the FDA Currently Waived Analytes list — at least one test system for this analyte is categorized CLIA-waived.
Last reviewed 2026-07-03
Waived status is device-specific and can change. This page does not confirm that a specific Hgb, Single Analyte Inst. W/self-cont. device is waived — verify your exact test system in the FDA CLIA database.
What "CLIA-waived" means for Hgb, Single Analyte Inst. W/self-cont.
- The FDA categorizes test systems by complexity. "Waived" is the lowest-complexity tier — tests simple enough that the FDA and CMS allow them under a Certificate of Waiver.
- HGB, SINGLE ANALYTE INST. W/SELF-CONT. being on the waived-analytes list means one or more cleared devices for it are waived. Your specific device and manufacturer determine the actual categorization.
- Running it in a clinic still requires a CLIA Certificate of Waiver and adherence to the manufacturer's instructions for use.
Add it under a waiver
Prepare a CMS-116 Certificate of Waiver listing Hgb, Single Analyte Inst. W/self-cont. with its test name, manufacturer, and estimated annual volume. Check your state — several add a lab-license step.
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