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QSS — Hiv Self-Tests Class III

FDA Device Classification

FDA product code QSS covers "Hiv Self-Tests", a Class III medical device. Submissions are reviewed by the Unknown panel.

Classification Details

Product Code: QSS
Device Class: Class III
Regulation Number
Submission Type
Review Panel: MI
Medical Specialty: Unknown
Implant: No

Definition

Human immunodeficiency virus (HIV) self-tests are intended for use by an individual to test themselves for the presence of HIV in body fluids.