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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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
RANDOX LABORATORIES, LTD.
  SUBSTANTIALLY EQUIVALENT 1
SEKISUI DIAGNOSTICS P.E.I. INC.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
VITAL DIAGNOSTICS (MANUFACTURING) PTYLTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 2 2
2018 1434 1434
2019 4 4
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Unable to Obtain Readings 1358 1358
Low Test Results 188 188
Human Factors Issue 1 1
Patient-Device Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 967 967
No Known Impact Or Consequence To Patient 470 470
No Clinical Signs, Symptoms or Conditions 1 1
Death, Intrauterine Fetal 1 1
Miscarriage 1 1
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories, Inc II Mar-30-2019
2 Medtest Holdings, Inc. III Jun-29-2017
3 Randox Laboratories Ltd. III May-16-2022
4 Siemens Healthcare Diagnostics, Inc. II Jul-02-2019
5 Siemens Healthcare Diagnostics, Inc. II May-04-2018
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