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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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New Search show TPLC since Back to Search Results
Device kit, test, pregnancy, hcg, over the counter
Regulation Description Human chorionic gonadotropin (HCG) test system.
Product CodeLCX
Regulation Number 862.1155
Device Class 2


Premarket Reviews
ManufacturerDecision
ACON LABORATORIES INC.
  SUBSTANTIALLY EQUIVALENT 1
GUANGZHOU WONDFO BIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SUGENTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 4 4
2017 1 1
2018 2 2
2019 3 3
2020 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 7 7
False Negative Result 2 2
Incorrect, Inadequate or Imprecise Resultor Readings 1 1
Defective Device 1 1
Device Operates Differently Than Expected 1 1
Device Displays Incorrect Message 1 1
Device Markings/Labelling Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 8 8
Insufficient Information 1 1
No Clinical Signs, Symptoms or Conditions 1 1
No Consequences Or Impact To Patient 1 1
Miscarriage 1 1
No Information 1 1

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