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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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New Search show TPLC since Back to Search Results
Device test, qualitative and quantitative factor deficiency
Product CodeGGP
Regulation Number 864.7290
Device Class 2


Premarket Reviews
ManufacturerDecision
INSTRUMENTATION LABORATORY CO.
  SUBSTANTIALLY EQUIVALENT 2
INSTRUMENTATION LABORATORY COMPANY
  SUBSTANTIALLY EQUIVALENT 1
PRECISION BIOLOGIC
  SUBSTANTIALLY EQUIVALENT 1
PRECISION BIOLOGIC INC.
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 1 1
2021 2 2
2022 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 5 5
Off-Label Use 1 1
High Test Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6 6
No Known Impact Or Consequence To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Aniara Diagnostica LLC II Mar-06-2023
2 Diagnostica Stago, Inc. II Apr-10-2020
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