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FDA 510(k)

BinaxNOW COVID-19 Ag Card

K-Number: K250273 · 2025-06-13

ApplicantAbbott Diagnostics Scarborough, Inc.
Decision Date2025-06-13
Product CodeQVF
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BinaxNOW COVID-19 Ag Card is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Diagnostics Scarborough, Inc.. It received FDA 510(k) clearance on 2025-06-13 under 510(k) number K250273. The device is classified under product code QVF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BinaxNOW COVID-19 Ag Card?

BinaxNOW COVID-19 Ag Card is a medical device that received FDA 510(k) clearance on 2025-06-13. The listed applicant is Abbott Diagnostics Scarborough, Inc.. The 510(k) number is K250273.

When did BinaxNOW COVID-19 Ag Card receive FDA 510(k) clearance?

BinaxNOW COVID-19 Ag Card received FDA 510(k) clearance on 2025-06-13, under 510(k) number K250273.

Who is the listed applicant for BinaxNOW COVID-19 Ag Card?

The FDA 510(k) record lists Abbott Diagnostics Scarborough, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BinaxNOW COVID-19 Ag Card?

The FDA product code for BinaxNOW COVID-19 Ag Card is QVF.

Other records listing Abbott Diagnostics Scarborough, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243518BinaxNOW™ COVID-19 Antigen Self TestK232775ID NOW Influenza A & B 2K221925ID NOW COVID-19 2.0PMA P940035System, test, tumor marker, for detection of bladder cancerK220801ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2K191534ID NOW Influenza A & B 2

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Related Devices (Code: QVF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253882CorDx Tyfast COVID-19 Ag Rapid Test RxCorDx, Inc.K251289WELLlife COVID-19 Antigen Test RxGuangzhou Wondfo Biotech Co., Ltd.K243872BD Veritor System for SARS-CoV-2Becton, Dickinson and CompanyK233358SCoV-2 Ag Detect Rapid TestInBios International, Inc.K232377Healgen Rapid COVID-19 Antigen TestHealgen Scientific,, LLCK231187Nano-Check™ COVID-19 Antigen TestNano-Ditech Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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