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U.S. Department of Health and Human Services

Product Classification

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Device antibody igm,if, cytomegalovirus virus
Regulation Description Cytomegalovirus serological reagents.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeLKQ
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Microbiology Devices (DMD)
Submission Type 510(k)
Regulation Number 866.3175
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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