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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
ACON LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
QUIDEL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2024 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3 3
Bacterial Infection 1 1
Unspecified Infection 1 1

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