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QHT — Reagent Red Blood Cells Class U

FDA Device Classification

FDA product code QHT covers "Reagent Red Blood Cells", a Class U medical device regulated under 21 CFR 660.30. Submissions are reviewed by the Hematology panel.

Classification Details

Product Code: QHT
Device Class: Class U
Regulation Number: 660.30
Submission Type
Review Panel: HE
Medical Specialty: Hematology
Implant: No

Definition

For the detection of or identification of human blood-group antibodies