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U.S. Department of Health and Human Services

Product Classification

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Device enzyme linked immunoabsorbent assay, varicella-zoster
Regulation Description Varicella-zoster virus serological reagents.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeLFY
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.3900
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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