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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
2017 2 2
2018 1434 1434
2019 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Unable to Obtain Readings 1358 1358
Low Test Results 187 187
Patient-Device Incompatibility 1 1
Human Factors Issue 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
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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