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Dynex Technologies Inc

Active in EUDAMED

United Statesfrom SRN EUDAMED FDA SRN US-MF-000014753

Devices
18
Registrations
EUDAMEDFDA
FDA recalls
31 ongoing
1 open since before 2021

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
United States
FDA establishment, FDA recalls

What Dynex Technologies Inc makes

Dynex Technologies Inc manufactures automated ELISA (enzyme-linked immunosorbent assay) processing systems, including the DS2 and DSX series with configurations featuring 2 or 4 incubators, as well as systems with integrated sample identification. The company also produces reagent and sample tips designed for compatibility with these platforms, alongside accompanying software solutions such as Revelation DSX and Agility software for workflow management and data analysis.

The company’s devices are classified as Class A under EU regulations and are listed in the eudamed database. Dynex Technologies Inc is headquartered in the United States.

AI-generated from registry data, 20 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue18

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Company details

EUDAMED SRN
US-MF-000014753
DUNS number
170119536
EUDAMED status
Active since 2015
EUDAMED registered name
Dynex Technologies Inc
Registered address
14340, Sullyfield Circle, 20151, Chantilly, United States
Phone
2026589049
PRRC contact
Aslam Loota(public in EUDAMED)

FDA recalls3

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

Recalls initiated per year

  • 2017 0
  • 2018 0
  • 2019 0
  • 2020 1
  • 2021 0
  • 2022 0
  • 2023 0
  • 2024 0
  • 2025 1
  • 2026 0

1 initiated before 2017

  • 2025

    • 16 Jul 2025 Z-2345-2025 Class II Ongoing The internal label affixed to the sample tip rack is incorrectly labeled as reagent tip racks. When scanned by the Agility instrument, the tip rack is misidentified as a different tip type, rendering it incompatible with the system and preventing use which causes a delay in obtaining patient results.via FDA establishment DYNEX TECHNOLOGIES, INC. Distribution: Domestic: CA, FL, NC, NJ, NY;

  • 2020

    • 5 Jul 2020 Z-1222-2022 Class II Open since 2020 Control samples aspirated from wrong SmartKit on the Agility. Agility software was updated to v1.4.7 to resolve the issue. This leads to a risk that a control from another assay's SmartKit will be used instead of the correct control, which may lead to delayed patient results.via FDA establishment DYNEX TECHNOLOGIES, INC. Distribution: Worldwide distribution - US Nationwide distribution in the states of AL, CA, DC, FL, GA, IL, IN, MA, MD, MI, NE, NJ, NY,…
      Full distribution text Worldwide distribution - US Nationwide distribution in the states of AL, CA, DC, FL, GA, IL, IN, MA, MD, MI, NE, NJ, NY, OH, PA, PR, TN, TX, UT, VA, WI, WV and the countries of Belgium, Brazil, China, Czech Republic, France, Germany, Mexico, Qatar, Romania, Russia, South Korea, Switzerland, Taiwan, and UK.

  • 2004

    • 11 Jun 2004 Z-1082-04 Unclassified (pre-2012) Terminated An accessory sampling tip for an in vitro diagnostic test instrument may be inadequately sealed and may cause false assay patient results.via FDA establishment DYNEX TECHNOLOGIES, INC. Distribution: Pipette tips were sold to seven OEMs for distribution to end users in the US and internationally.

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • Dynex Technologies, Inc. CHANTILLY, VA · US FEI 1117676

From the company website

Read 18 Oct 2026

US-based manufacturer of fully automated ELISA processing systems for laboratories and research clinics of all sizes, including the DS2®, DSX®, and Agility® ELISA systems.

From the manufacturer's own website. Source

Frequently asked questions

How many devices does Dynex Technologies Inc have in the registry?

The registry currently lists 18 devices for Dynex Technologies Inc. Devices recorded under merged duplicate company entries are counted once.

Which registries list Dynex Technologies Inc's devices?

Among its 18 most recently registered devices, Dynex Technologies Inc has devices listed in EUDAMED (17 devices) and FDA GUDID (5 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Dynex Technologies Inc's devices fall under?

Among its 18 most recently registered devices, the classes recorded for Dynex Technologies Inc's devices are Class I and IVDR Class A. Each device page shows its own class and authorisation.

Are there FDA recall records for Dynex Technologies Inc?

FDA recall records list 3 recalls initiated by Dynex Technologies Inc, the most recent initiated on 2025-07-16. 2 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Dynex Technologies Inc in the registry?

The most recently registered devices listed for Dynex Technologies Inc include DEEP WELL STRIPS, DS Matrix Software, DSX Automated ELISA System with 4 incubators and AGILITY REAGENT TIPS.

Which FDA establishments are linked to Dynex Technologies Inc?

1 FDA establishment is linked to Dynex Technologies Inc in the registry; they are listed on the company page.

Generated automatically from registry data and not verified by a human reviewer.