Abbott Molecular, Inc.

Abbott Molecular, Inc. — FDA 510(k) Submissions

Abbott Molecular, Inc. has submitted 17 FDA 510(k) premarket notifications since 2008, of which 16 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections, Nucleic Acid Amplification Test For The Quantitation Of Epstein-barr Virus (ebv) Dna, Herpes Virus (vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples, Early Growth Response Gene 1 (egr1) Fish Probe Kit For Specimen Characterization, Multi-target Respiratory Specimen Nucleic Acid Test Including Sars-cov-2 And Other Microbial Agents . Use the specialty filter in the sidebar to narrow results.