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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 molecular test to detect sars-cov-2 from clinical specimens
Definition An over-the-counter molecular test to detect SARS-CoV-2 is an in vitro diagnostic device for the detection of SARS-CoV-2 in clinical specimens to aid in the diagnosis of SARS-CoV-2 infection. The device is intended to be used by lay users and without health care provider (HCP) intervention in home settings or similar environments.
Product CodeQWB
Regulation Number 866.3984
Device Class 2


Premarket Reviews
ManufacturerDecision
CUE HEALTH INC.
  GRANTED 1
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2024 1 1

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

Recalls
Manufacturer Recall Class Date Posted
1 CUE HEALTH INC II Oct-15-2024
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