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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
CORDX, INC.
  SUBSTANTIALLY EQUIVALENT 1
GENABIO DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
GUANGZHOU WONDFO BIOTECH CO., LTD.
  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

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 62 62
False Positive Result 15 15
Device Markings/Labelling Problem 9 9
Improper or Incorrect Procedure or Method 5 5
No Apparent Adverse Event 4 4
Non Reproducible Results 1 1
Expiration Date Error 1 1
Patient Device Interaction Problem 1 1
Component Missing 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 87 87
Insufficient Information 15 15
Unspecified Infection 1 1
Skin Inflammation/ Irritation 1 1
Bacterial Infection 1 1
Eye Pain 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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