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Abbott Molecular FDA Approvals

0 new drug approvals and 2 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
simpli-COLLECT STI Test510(k)Jan 30, 2025Microbiology
Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086)510(k)Dec 6, 2024Microbiology

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