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U.S. Department of Health and Human Services

Product Classification

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Device test, euglobulin lysis
Regulation Description Euglobulin lysis time tests.
Regulation Medical Specialty Hematology
Review Panel Hematology
Product CodeJBO
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type Enforcement Discretion
Regulation Number 864.7275
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons