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TPLC
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show TPLC since
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Device
test, qualitative, for hla, non-diagnostic
Product Code
MZI
Device Class
Unclassified
Premarket Reviews
Manufacturer
Decision
IMMUCOR GTI DIAGNOSTICS, INC.
SUBSTANTIALLY EQUIVALENT
8
IMMUCOR TRANSPLANT DIAGNOSTICS, INC.
SUBSTANTIALLY EQUIVALENT
2
ONE LAMBDA, INC.
SUBSTANTIALLY EQUIVALENT
4
MDR Year
MDR Reports
MDR Events
2016
6
6
2018
21
21
2019
2
2
2020
2
2
2021
4
4
2023
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
9
9
Incorrect, Inadequate or Imprecise Result or Readings
6
6
Off-Label Use
5
5
Computer Software Problem
3
3
Improper or Incorrect Procedure or Method
3
3
Device Operates Differently Than Expected
2
2
Appropriate Term/Code Not Available
2
2
Insufficient Information
2
2
False Positive Result
2
2
Output Problem
1
1
Non Reproducible Results
1
1
Device Markings/Labelling Problem
1
1
Use of Device Problem
1
1
No Apparent Adverse Event
1
1
Incorrect Measurement
1
1
Missing Test Results
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
25
25
No Clinical Signs, Symptoms or Conditions
8
8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
No Information
2
2
Missing Value Reason
2
2
No Code Available
1
1
No Patient Involvement
1
1
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