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TPLC
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show TPLC since
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Device
kit, test,alpha-fetoprotein for testicular cancer
Product Code
LOJ
Regulation Number
866.6010
Device Class
2
Premarket Reviews
Manufacturer
Decision
ORTHO CLINICAL DIAGNOSTICS
SUBSTANTIALLY EQUIVALENT
1
ROCHE DIAGNOSTICS
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
14
14
2020
1
1
2021
5
5
2022
1
1
2023
3
3
2024
3
3
Device Problems
MDRs with this Device Problem
Events in those MDRs
High Test Results
9
9
No Apparent Adverse Event
9
9
Low Test Results
5
5
Off-Label Use
4
4
Non Reproducible Results
4
4
Contamination /Decontamination Problem
1
1
Incorrect, Inadequate or Imprecise Result or Readings
1
1
Mechanical Problem
1
1
Adverse Event Without Identified Device or Use Problem
1
1
False Positive Result
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
11
11
No Known Impact Or Consequence To Patient
9
9
No Consequences Or Impact To Patient
5
5
No Information
1
1
Insufficient Information
1
1
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