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TPLC
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Device
nad reduction/nadh oxidation, cpk or isoenzymes
Product Code
CGS
Regulation Number
862.1215
Device Class
2
Premarket Reviews
Manufacturer
Decision
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
2024
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Unable to Obtain Readings
1358
1358
Low Test Results
189
189
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
No Clinical Signs, Symptoms or Conditions
2
2
Miscarriage
1
1
No Consequences Or Impact To Patient
1
1
Death, Intrauterine Fetal
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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