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U.S. Department of Health and Human Services

Product Classification

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Device dna-reagents, cytomegalovirus
Regulation Description Cytomegalovirus serological reagents.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeLSO
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.3175
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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