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Abbott Diagnostics Scarborough, Inc. FDA Approvals

0 new drug approvals and 6 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product
ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0510(k)Aug 31, 2026Microbiology
BinaxNOW COVID-19 Ag Card510(k)Jun 13, 2025Microbiology
BinaxNOW™ COVID-19 Antigen Self Test510(k)Feb 11, 2025Microbiology
ID NOW Influenza A & B 2510(k)Oct 10, 2023Microbiology
ID NOW COVID-19 2.0510(k)Aug 10, 2023Microbiology
ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2510(k)Jun 24, 2022Microbiology

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