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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device software, blood bank, stand alone products
Regulation Description Automated blood grouping and antibody test system.
Product CodeMMH
Regulation Number 864.9175
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 5
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 2
BAYER
  SUBSTANTIALLY EQUIVALENT 3
CERNER CORP.
  SUBSTANTIALLY EQUIVALENT 7
Data Innovations Inc.
  SUBSTANTIALLY EQUIVALENT 4
EPIC
  SUBSTANTIALLY EQUIVALENT 1
FIFTH DIMENSION INFORMATION SYSTEMS
  SUBSTANTIALLY EQUIVALENT 6
GLOBAL MED TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 8
HAEMONETICS CORP.
  SUBSTANTIALLY EQUIVALENT 8
IMMUCOR, INC.
  SUBSTANTIALLY EQUIVALENT 2
INFORMATION DATA MANAGEMENT, INC.
  SUBSTANTIALLY EQUIVALENT 12
KENDALL
  SUBSTANTIALLY EQUIVALENT 4
MCKESSON
  SUBSTANTIALLY EQUIVALENT 1
MISYS HOSPITAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
ORTHO-CLINICAL
  SUBSTANTIALLY EQUIVALENT 3
RED CROSS
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
SCC
  SUBSTANTIALLY EQUIVALENT 8

Device Problems
Computer software issue 3
Incorrect display 1
Date-related software issue 1
Pipette, failure to aspirate 1
No Information 1
Alarm, failure of warning 1
Total Device Problems 8

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