Product Classification

• Device: test, nr2 antibody
• Definition: Nr2 is an independent blood-borne marker that rules in cerebral ischemic event and rules out hemorrhage.
• Physical State: Reagent test kit
• Technical Method: Enzyme-linked immunosorbent assay (ELISA)
• Target Area: in vitro diagnostic device using human serum samples
• Review Panel: Clinical Chemistry
• Product Code: PAQ
• Not Classified Reason: For Export Only
• Submission Type: Contact ODE
• Device Class: Not Classified
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Third Party Review

Not Third Party Eligible