5 results
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6ms
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Sources: EU EUDAMED, US FDA
VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021; for use with the sample-to-results VERIGENE System; invitro diagnostic test
FDA Enforcement
Class II
·Completed·Luminex Corporation·June 11, 2025
AD-TECH Spencer Probe Depth Electrode, REF SD04R-AP58X-000 4-Contact 1.12mm (A style) Depth Electrode
FDA Enforcement
Class II
·Completed·Ad-Tech Medical Instrument Corporation·October 30, 2024
AD-TECH Spencer Probe Depth Electrode, REF SD06R-AP58X-000 6-Contact 1.12mm (A style) Depth Electrode
FDA Enforcement
Class II
·Completed·Ad-Tech Medical Instrument Corporation·October 30, 2024
AD-TECH Spencer Probe Depth Electrode, REF SD08R-AP58X-000 8-Contact 1.12mm (A style) Depth Electrode
FDA Enforcement
Class II
·Completed·Ad-Tech Medical Instrument Corporation·October 30, 2024
greiner bio-one VACUETTE TUBE 6 ml K3E K3EDTA, 13x100 pink cap-black ring, non-ridged, 24 racks of 50 pcs., 1200 pcs in total, Item #456003
FDA Enforcement
Class II
·Completed·Greiner Bio-One North America, Inc.·May 24, 2023