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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device over-the-counter covid-19 antigen test
Definition For the rapid, qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen in individuals 2 years and older.
Product CodeQYT
Regulation Number 866.3984
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
  SUBSTANTIALLY EQUIVALENT 1
ACCESS BIO, INC.
  SUBSTANTIALLY EQUIVALENT 1
ACON LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
ASSURE TECH., LLC
  SUBSTANTIALLY EQUIVALENT 1
CORDX, INC.
  SUBSTANTIALLY EQUIVALENT 1
GENABIO DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
GENBODY.INC.
  SUBSTANTIALLY EQUIVALENT 1
GUANGZHOU WONDFO BIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HEALGEN SCIENTIFIC,, LLC
  SUBSTANTIALLY EQUIVALENT 1
IHEALTH LABS, INC.
  SUBSTANTIALLY EQUIVALENT 1
INBIOS INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
OSANG, LLC
  SUBSTANTIALLY EQUIVALENT 1
QUIDEL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2024 23 23
2025 83 83
2026 33 33

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 74 74
False Positive Result 29 29
Device Markings/Labelling Problem 9 9
Improper or Incorrect Procedure or Method 8 8
No Apparent Adverse Event 6 6
Non Reproducible Results 3 3
Patient Device Interaction Problem 1 1
Expiration Date Error 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 118 118
Insufficient Information 15 15
Burning Sensation 1 1
Bacterial Infection 1 1
Eye Pain 1 1
Unspecified Infection 1 1
Epistaxis 1 1
Ear infection 1 1
Skin Inflammation/ Irritation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD II Sep-27-2024
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