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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 nad reduction/nadh oxidation, cpk or isoenzymes
Product CodeCGS
Regulation Number 862.1215
Device Class 2


Premarket Reviews
ManufacturerDecision
MEDTEST DX
  SUBSTANTIALLY EQUIVALENT 1
SEKISUI DIAGNOSTICS P.E.I. INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 4 4
2022 1 1
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 3 3
Unable to Obtain Readings 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 3 3
No Clinical Signs, Symptoms or Conditions 2 2
No Known Impact Or Consequence To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories, Inc II Mar-30-2019
2 Randox Laboratories Ltd. III May-16-2022
3 Siemens Healthcare Diagnostics, Inc. II Jul-02-2019
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