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U.S. Department of Health and Human Services

Product Classification
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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 CodePAQ
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Chemistry and Toxicology Devices (DCTD)
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
Summary Malfunction
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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