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U.S. Department of Health and Human Services

Product Classification

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Device antisera, fluorescent, all groups, n. meningitidis
Regulation Description Neisseriaspp. direct serological test reagents.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeGTI
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.3390
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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