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TPLC
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show TPLC since
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Device
dna-reagents, neisseria
Product Code
LSL
Regulation Number
866.3390
Device Class
2
Premarket Reviews
Manufacturer
Decision
HOLOGIC, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
14
14
2020
3
3
2021
4
4
2022
12
12
2023
23
23
2024
10
10
Device Problems
MDRs with this Device Problem
Events in those MDRs
False Positive Result
19
19
False Negative Result
16
16
No Apparent Adverse Event
16
16
Device Markings/Labelling Problem
3
3
Contamination
2
2
Incorrect, Inadequate or Imprecise Result or Readings
2
2
Product Quality Problem
2
2
Improper or Incorrect Procedure or Method
2
2
Activation, Positioning or Separation Problem
1
1
Output Problem
1
1
Off-Label Use
1
1
Use of Device Problem
1
1
Installation-Related Problem
1
1
Non Reproducible Results
1
1
Insufficient Information
1
1
Erratic Results
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
45
45
Unspecified Infection
14
14
Viral Infection
5
5
Test Result
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Insufficient Information
1
1
Eye Injury
1
1
Sexually Transmitted Infection
1
1
No Consequences Or Impact To Patient
1
1
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