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U.S. Department of Health and Human Services

Product Classification

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Device test, antigen, nuclear, epstein-barr virus
Regulation Description Epstein-Barr virus serological reagents.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeLLM
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Microbiology Devices (DMD)
Submission Type 510(k)
Regulation Number 866.3235
Device Class 1
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
Accredited Persons
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