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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device antigens, all groups, streptococcus spp.
Product CodeGTY
Regulation Number 866.3740
Device Class 1


Premarket Reviews
ManufacturerDecision
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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