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TPLC
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show TPLC since
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Device
antigens, all groups, streptococcus spp.
Product Code
GTY
Regulation Number
866.3740
Device Class
1
Premarket Reviews
Manufacturer
Decision
HEALGEN SCIENTIFIC, LLC
SUBSTANTIALLY EQUIVALENT
1
QUIDEL CORPORATION
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2017
2
2
2018
12
12
2019
6
6
2020
1
1
2021
37
37
2022
22
22
Device Problems
MDRs with this Device Problem
Events in those MDRs
False Positive Result
32
32
False Negative Result
22
22
Incorrect, Inadequate or Imprecise Resultor Readings
17
17
Break
2
2
Fire
2
2
Leak/Splash
1
1
Chemical Spillage
1
1
Contamination of Device Ingredient or Reagent
1
1
Device Markings/Labelling Problem
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
57
57
No Consequences Or Impact To Patient
20
20
No Code Available
3
3
No Information
2
2
Red Eye(s)
1
1
Chemical Exposure
1
1
No Known Impact Or Consequence To Patient
1
1
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