Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Product Classification
  • Print
  • Share
  • E-mail
-
New Search Back to Search Results
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
Summary Malfunction
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
-
-