3 results
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36ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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GenetiSure Dx Labeling Kit, REF: K1201-64105, contains human reference DNA female aliquot, REF5190-7317. A required kit for the GenetiSure Dx Postnatal assay (K1201A).
FDA Enforcement
Class II
·Ongoing·Agilent Technologies, Inc.·April 16, 2025
Kit Label: Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-2 Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-21 Vial Labels: Mat. No K589911-21512
FDA Enforcement
Class III
·Ongoing·Agilent Technologies, Inc.·July 20, 2022
Agilent Resolution ctDx FIRST Sample Collection Kit, 500032
FDA Enforcement
Class III
·Ongoing·AGILENT TECHNOLOGIES INC./US·April 19, 2023