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TPLC
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Device
system, test, carcinoembryonic antigen
Regulation Description
Tumor-associated antigen immunological test system.
Product Code
DHX
Regulation Number
866.6010
Device Class
2
Premarket Reviews
Manufacturer
Decision
BECKMAN COULTER, INC
SUBSTANTIALLY EQUIVALENT
1
ORTHO CLINICAL DIAGNOSTICS
SUBSTANTIALLY EQUIVALENT
1
SIEMENS HEALTHCARE DISGNOSTICS INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
14
14
2021
11
11
2022
12
12
2023
16
16
2024
15
15
2025
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
High Test Results
32
32
Low Test Results
26
26
Non Reproducible Results
9
9
No Apparent Adverse Event
4
4
Incorrect, Inadequate or Imprecise Result or Readings
4
4
Incorrect Measurement
2
2
Mechanical Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
54
54
No Known Impact Or Consequence To Patient
11
11
No Consequences Or Impact To Patient
4
4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
No Information
1
1
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