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TPLC - Total Product Life Cycle
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Device manual blood grouping and antibody test systems
Definition A manual blood grouping and antibody test system is used to group red blood cells and to detect antibodies to blood group antigens.
Product CodePBC
Regulation Number 864.9175
Device Class 2


Premarket Reviews
ManufacturerDecision
BIO-RAD MEDICAL DIAGNOSTICS GMBH
  SUBSTANTIALLY EQUIVALENT 2
DIAGNOSTIC GRIFOLS, S. A.
  SUBSTANTIALLY EQUIVALENT 5
  1.  BK120043  Manual blood grouping and antibody test systems
  2.  BK120044  Manual blood grouping and antibody test systems
  3.  BK120045  Manual blood grouping and antibody test systems
  4.  BK120046  Manual blood grouping and antibody test systems
  5.  BK140101  Manual blood grouping and antibody test systems

MDR Year MDR Reports MDR Events
2016 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 1 1

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