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TPLC
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show TPLC since
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Device
enzyme linked immunosorbent assay, herpes simplex virus, hsv-2
Product Code
MYF
Regulation Number
866.3305
Device Class
2
Premarket Reviews
Manufacturer
Decision
BIOKIT, S.A.
SUBSTANTIALLY EQUIVALENT
1
QUEST INTERNATIONAL, INC.
SUBSTANTIALLY EQUIVALENT
2
ROCHE DIAGNOSTICS
SUBSTANTIALLY EQUIVALENT
1
ZEUS SCIENTIFIC, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
1
1
2021
2
2
2023
252
252
2024
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
False Positive Result
190
190
Incorrect, Inadequate or Imprecise Result or Readings
60
60
Low Test Results
1
1
Device Remains Activated
1
1
False Negative Result
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
150
150
Insufficient Information
104
104
No Consequences Or Impact To Patient
1
1
Viral Infection
1
1
Anxiety
1
1
Depression
1
1
Sleep Dysfunction
1
1
Decreased Appetite
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Diasorin Inc.
II
Jan-25-2024
2
Siemens Healthcare Diagnostics, Inc
II
Mar-18-2021
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