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U.S. Department of Health and Human Services

Product Classification

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Device epstein-barr virus, other
Regulation Description Epstein-Barr virus serological reagents.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeLSE
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.3235
Device Class 1
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