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QHR — Blood Grouping Reagent Class U

FDA Device Classification

FDA product code QHR covers "Blood Grouping Reagent", a Class U medical device regulated under 21 CFR 660.20. Submissions are reviewed by the Hematology panel.

Classification Details

Product Code: QHR
Device Class: Class U
Regulation Number: 660.20
Submission Type
Review Panel: HE
Medical Specialty: Hematology
Implant: No

Definition

For red blood cell antigen typing