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Abbott Molecular

FDA 510(k) & PMA Approved Devices — 5 products

Total Devices5
Categories4
Latest FDA decision2026-02-18
TypeNumberDevice NameCodeDateActions
PMA P030052 Unknown Device2026-02-18 View
510(k) K243410 simpli-COLLECT STI TestQYA2025-01-30 View
510(k) K241580 Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086)QQX2024-12-06 View
PMA P160044 Cytomegalovirus (cmv) dna quantitative assayPAB2023-01-13 View
PMA P120012 Assay, genotyping, hepatitis c virusOBF2021-03-05 View
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