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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device kit, quality control for blood banking reagents
Product CodeKSF
Regulation Number 864.9650
Device Class 2


Premarket Reviews
ManufacturerDecision
ALBA BIOSCIENCE LIMITED
  SUBSTANTIALLY EQUIVALENT 2
DIAGAST
  SUBSTANTIALLY EQUIVALENT 1
IMMUCOR, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDION GRIFOLS DIAGNOSTICS AG
  SUBSTANTIALLY EQUIVALENT 1
MILLIPORE (UK) LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 10 10
2020 1 1
2022 1 1
2023 2 2
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 8 8
Off-Label Use 2 2
Defective Device 2 2
Nonstandard Device 2 2
False Positive Result 2 2
Short Fill 1 1
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 8 8
No Clinical Signs, Symptoms or Conditions 3 3
No Consequences Or Impact To Patient 2 2
Patient Problem/Medical Problem 1 1
Fever 1 1
Unspecified Eye / Vision Problem 1 1

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