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U.S. Department of Health and Human Services

Product Classification
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Device self-contained blood grouping
Regulation Description Automated blood grouping and antibody test system.
Definition Intended for single use for individual blood group determination for educational and informational purposes
Physical State Plastic card with mixing channels and monoclonal antibodies
Technical Method The device is self-contained and consists of reagents and reaction areas and requires no other accessories with the exception of those used to add the blood sample to the device
Target Area Plastic/paper card, plate, slide or microtubules with blood grouping antibodies
Regulation Medical Specialty Hematology
Review Panel Hematology
Product CodeOQX
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
Summary Malfunction
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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