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510(k) K243518

BinaxNOW™ COVID-19 Antigen Self Test by Abbott Diagnostics Scarborough, Inc. — Product Code QYT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 2025
Date Received
November 13, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Over-The-Counter Covid-19 Antigen Test
Device Class
Class II
Regulation Number
866.3984
Review Panel
MI
Submission Type

For the rapid, qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen in individuals 2 years and older.

Other clearances by Abbott Diagnostics Scarborough, Inc.

  • K250273 — BinaxNOW COVID-19 Ag Card (June 13, 2025)
  • K232775 — ID NOW Influenza A & B 2 (October 10, 2023)
  • K221925 — ID NOW COVID-19 2.0 (August 10, 2023)
  • K220801 — ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2 (June 24, 2022)
  • K191534 — ID NOW Influenza A & B 2 (July 11, 2019)

Other clearances for product code QYT

  • K251916 — GenBody COVID-19 Ag Home Test (March 13, 2026)
  • K251595 — COVID-19 Detect Rapid Self -Test (October 12, 2025)
  • K251753 — GenaCheck COVID-19 Rapid Self-Test (September 5, 2025)
  • K241313 — OHC COVID-19 Antigen Self Test (May 30, 2025)
  • K241915 — CareSuperb™ COVID-19 Antigen Home Test (January 29, 2025)
  • K241317 — Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) (September 30, 2024)
  • K240728 — CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag Test (June 21, 2024)
  • K233842 — iHealth COVID-19 Antigen Rapid Test (May 31, 2024)
  • K233373 — Flowflex® Plus COVID-19 Home Test (April 19, 2024)
  • K231795 — QuickVue COVID-19 Test (March 22, 2024)