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U.S. Department of Health and Human Services

Product Classification

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Device glutathione, red-cell
Regulation Description Glutathione reductase assay.
Regulation Medical Specialty Hematology
Review Panel Hematology
Product CodeGII
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type Enforcement Discretion
Regulation Number 864.7375
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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