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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
BIOFORTUNA LTD
SUBSTANTIALLY EQUIVALENT
1
GEN-PROBE
SUBSTANTIALLY EQUIVALENT
2
GEN-PROBE GTI DIAGNOSTICS
SUBSTANTIALLY EQUIVALENT
1
GENETIC TESTING INSTITUTE, INC. (GTI)
SUBSTANTIALLY EQUIVALENT
1
IMMUCOR GTI DIAGNOSTICS, INC.
SUBSTANTIALLY EQUIVALENT
9
IMMUCOR TRANSPLANT DIAGNOSTICS, INC.
SUBSTANTIALLY EQUIVALENT
3
LIFE TECHNOLOGIES CORPORATION
SUBSTANTIALLY EQUIVALENT
1
OLERUP SSP AB
SUBSTANTIALLY EQUIVALENT
2
ONE LAMBDA, INC
SUBSTANTIALLY EQUIVALENT
4
ONE LAMBDA, INC.
SUBSTANTIALLY EQUIVALENT
6
TEPNEL LIFECODES CORPORATION
SUBSTANTIALLY EQUIVALENT
1
1. BK090018
Test, Qualitative, for HLA, Non-Diagnostic
TEXAS BIOGENE, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
209
209
2015
97
97
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
Device Operates Differently Than Expected
119
119
Nonstandard Device
94
94
Incorrect Or Inadequate Test Results
73
73
Incorrect, Inadequate or Imprecise Result or Readings
70
70
High Test Results
20
20
False Positive Result
11
11
Adverse Event Without Identified Device or Use Problem
11
11
False Negative Result
6
6
High Readings
5
5
Off-Label Use
5
5
Imprecision
3
3
Computer Software Problem
3
3
Improper or Incorrect Procedure or Method
3
3
Device Markings/Labelling Problem
3
3
Insufficient Information
3
3
Appropriate Term/Code Not Available
2
2
Data Problem
2
2
Filtration Problem
2
2
Device Displays Incorrect Message
1
1
Electrical /Electronic Property Problem
1
1
Incorrect Measurement
1
1
Use of Device Problem
1
1
Missing Test Results
1
1
Non Reproducible Results
1
1
Output Problem
1
1
No Apparent Adverse Event
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
196
196
Not Applicable
110
111
No Information
15
15
No Consequences Or Impact To Patient
11
11
No Clinical Signs, Symptoms or Conditions
8
8
Missing Value Reason
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Reintubate
1
1
No Patient Involvement
1
1
No Code Available
1
1
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