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U.S. Department of Health and Human Services

Product Classification

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Device manual blood grouping and antibody test systems
Regulation Description Automated blood grouping and antibody test system.
Definition A manual blood grouping and antibody test system is used to group red blood cells and to detect antibodies to blood group antigens.
Physical State Solid
Technical Method Manual
Target Area IVD
Regulation Medical Specialty Hematology
Review Panel Hematology
Product CodePBC
Premarket Review Center for Biologics Evaluation & Research (CBER)
Submission Type 510(k)
Regulation Number 864.9175
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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