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U.S. Department of Health and Human Services

Product Classification

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Device antigen, cf, (including cf control), varicella-zoster
Regulation Description Varicella-zoster virus serological reagents.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeGQW
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
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons