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QGU — Hemoglobin For Donor Testing Class II

FDA Device Classification

FDA product code QGU covers "Hemoglobin For Donor Testing", a Class II medical device regulated under 21 CFR 864.7500. Submissions are reviewed by the Hematology panel.

Classification Details

Product Code: QGU
Device Class: Class II
Regulation Number: 864.7500
Submission Type
Review Panel: HE
Medical Specialty: Hematology
Implant: No

Definition

Assays hemoglobin concentration test for blood donors.