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Abbott Molecular

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

Total Devices5
Categories5
Latest Approval2025-01-30
TypeNumberDevice NameCodeDate
510(k) K243410 simpli-COLLECT STI Test QYA 2025-01-30 View
510(k) K241580 Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086) QQX 2024-12-06 View
PMA P160044 Cytomegalovirus (cmv) dna quantitative assay PAB 2017-09-01 View
PMA P120012 Assay, genotyping, hepatitis c virus OBF 2016-12-23 View
PMA P030052 Test, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for recurrence NSD 2016-10-11 View
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