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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.
Regulation Description Streptococcus spp. serological reagents.
Product CodeGTY
Regulation Number 866.3740
Device Class 1


Premarket Reviews
ManufacturerDecision
HEALGEN SCIENTIFIC, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 1 1
2021 37 37
2022 32 32
2023 44 44
2024 41 41
2025 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 58 58
Incorrect, Inadequate or Imprecise Result or Readings 45 45
False Negative Result 43 43
Break 3 3
Fire 2 2
Defective Component 2 2
Leak/Splash 1 1
Device Markings/Labelling Problem 1 1
Defective Device 1 1
Component Missing 1 1
Material Separation 1 1
Contamination of Device Ingredient or Reagent 1 1
Detachment of Device or Device Component 1 1
Missing Information 1 1
Inaccurate Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 155 155
No Consequences Or Impact To Patient 4 4
Choking 2 2
No Known Impact Or Consequence To Patient 1 1
Insufficient Information 1 1
Bacterial Infection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cypress Medical Products LLC II Sep-19-2024
2 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
3 Wondfo USA Co Ltd II Jun-07-2024
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