All CLIA-waived tests

CLIA-waived analyte

aerobic/anaerobic organisms - vaginal: CLIA-waived test status.

AEROBIC/ANAEROBIC ORGANISMS - VAGINAL 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 Aerobic/anaerobic Organisms - Vaginal device is waived — verify your exact test system in the FDA CLIA database.

What "CLIA-waived" means for Aerobic/anaerobic Organisms - Vaginal

  • 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.
  • AEROBIC/ANAEROBIC ORGANISMS - VAGINAL 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 Aerobic/anaerobic Organisms - Vaginal with its test name, manufacturer, and estimated annual volume. Check your state — several add a lab-license step.

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