12 results
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48ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DYNEX TECHNOLOGIES, INC.
FDA registration
DYNEX TECHNOLOGIES, INC.·3 products·🇺🇸 United States
DYNEX Agility
FDA UDI
DYNEX TECHNOLOGIES, INC.·05060456180058·Automated ELISA Processing System with 12 Incub...
DYNEX DS2
FDA UDI
DYNEX TECHNOLOGIES, INC.·05060456180317·DS2 Automated ELISA Processing System
DIALISA 2MP
FDA UDI
DYNEX TECHNOLOGIES, INC.·05060456180348·DIALISA 2MP, DS2 Automated ELISA Processing System
DYNEX DS2
FDA UDI
DYNEX TECHNOLOGIES, INC.·05060456180003·DS2 Automated ELISA Processing System, with Bar...
DYNEX DSX
FDA UDI
DYNEX TECHNOLOGIES, INC.·05060456180287·Automated ELISA Processing System with 0 Incuba...
DSX
FDA Adverse Event
DYNEX TECHNOLOGIES INC·Product code JQW·January 3, 2017
DYNEX Agility, Agility Analyzer, Model No. 67000
FDA Recall
Open, Classified
·Dynex Technologies, Inc.·Product code LXG·July 5, 2020
Pipette Sample Tip, Product part #65910, packaged in cardboard cartons containing 4 plastic racks of 108 pipette tips per rack. Pipette tips are accessory component for Dynex Technologies proprietary automated DSX system.
FDA Recall
Terminated
·Dynex Technologies, Inc.·Product code JQW·June 11, 2004
Dynex Agility Sample Tips; Model Number: 67910; The 67910 Agility Sample Tips are an accessory/consumable used with the Agility Automated ELISA system.
FDA Recall
Open, Classified
·Dynex Technologies, Inc.·Product code LXG·July 16, 2025
Dynex Agility Sample Tips; Model Number: 67910; The 67910 Agility Sample Tips are an accessory/consumable used with the Agility Automated ELISA system.
FDA Enforcement
Class II
·Ongoing·Dynex Technologies, Inc.·August 27, 2025
DYNEX Agility, Agility Analyzer, Model No. 67000
FDA Enforcement
Class II
·Ongoing·Dynex Technologies, Inc.·June 8, 2022