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Abbott Molecular, Inc. FDA Approvals
0 new drug approvals and 9 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 |
|---|
| Alinity m HCV510(k)Sep 25, 2025Microbiology |
| Alinity m EBV (09N43-095)510(k)Jul 28, 2025Microbiology |
| Alinity m CMV510(k)Jul 1, 2025Microbiology |
| Alinity m BKV510(k)Mar 24, 2025Microbiology |
| Alinity m Resp-4-Plex510(k)Feb 14, 2025Microbiology |
| Alinity m HSV 1 & 2 / VZV510(k)May 3, 2024Microbiology |
| Alinity m STI Assay510(k)Mar 3, 2023Microbiology |
| Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085), Alinity m EBV CAL Kit (List No. 09N43-075)510(k)Jul 15, 2022Microbiology |
| Alinity m STI Assay510(k)Apr 29, 2022Microbiology |