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# FDA Cautions 2 HIV Test Distributors
- URL: https://www.fdaweb.com/fda-cautions-2-hiv-test-distributors/
- Published: 2018-08-14T12:00:00.000Z
- Updated: 2026-09-15T00:25:26.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5142109

FDA has sent untitled letters to registrants of two Web sites that promote the iCare HIV 1&2 Rapid Screen Test and the iCare One-Step HIV 1/2 Oral Fluid Test cautioning that the tests are not approved for sale in the U.S. and have not received investigational device exemptions from premarket approval. The letter also expresses agency concern about the accuracy of some statements in the product labeling.

Letters went to the registrants of [testhivstatus.com](http://www.fda.ogv/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ComplianceActivities/Enforcement/UntitledLetters/UCM616777.pdf?ref=fdaweb.com) and [stdrapidtest.com](http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ComplianceActivities/ENforcement/UntitledLetters/UCM616759.pdf?ref=fdaweb.com).