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PAQ — Test, Nr2 Antibody Class N

FDA Device Classification

FDA product code PAQ covers "Test, Nr2 Antibody", a Class N medical device. Submissions are reviewed by the Unknown panel.

Classification Details

Product Code: PAQ
Device Class: Class N
Regulation Number
Submission Type
Review Panel: CH
Medical Specialty: Unknown
Implant: No

Definition

NR2 is an independent blood-borne marker that rules in cerebral ischemic event and rules out hemorrhage.