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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
ACESO LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
ACON LABORATORIES INC.
  SUBSTANTIALLY EQUIVALENT 1
ACON LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
ANDON HEALTH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
ASSURE TECH (HANGZHOU) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ASSURE TECH LLC
  SUBSTANTIALLY EQUIVALENT 2
ATLAS LINK TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CO-INNOVATION BIOTECH CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
GUANGZHOU DECHENG BIOTECHNOLOGY CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
GUANGZHOU DECHENG BIOTECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
HANGZHOU AICHEK MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HANGZHOU ALLTEST BIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
HANGZHOU SEJOY ELECTRONICS & INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HEALSTONE BIOTECH INC.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU MACRO & MICRO-TEST MED-TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NANJING SYNTHGENE MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NANTONG EGENS BIOTECHNOLOGY CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
SAFECARE BIOTECH (HANGZHOU) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SPD SWISS PRECISION DIAGNOSTICS GMBH
  SUBSTANTIALLY EQUIVALENT 4

MDR Year MDR Reports MDR Events
2020 3 5
2021 4 6
2022 12 28
2023 6 6
2024 3 3
2025 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 15 34
Defective Device 5 5
Incorrect, Inadequate or Imprecise Result or Readings 5 5
Activation, Positioning or Separation Problem 4 4
False Negative Result 1 1
Device Markings/Labelling Problem 1 1
Insufficient Information 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Missing Test Results 1 1
Product Quality Problem 1 1
Device Displays Incorrect Message 1 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 18 26
No Clinical Signs, Symptoms or Conditions 12 14
Emotional Changes 2 2
No Known Impact Or Consequence To Patient 1 1
Distress 1 11

Recalls
Manufacturer Recall Class Date Posted
1 Church & Dwight Inc II Apr-07-2023
2 Family Dollar Stores, Llc. II Nov-07-2023
3 Family Dollar Stores, Llc. II Aug-17-2022
4 Universal Meditech Inc. II Oct-23-2023
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