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U.S. Department of Health and Human Services

Product Classification
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Device antigen, ha (including ha control), rubella
Regulation Description Rubella virus serological reagents.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeGOL
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Microbiology Devices (DMD)
Submission Type 510(k)
Regulation Number 866.3510
Device Class 2
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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