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Oxford Immunotec Ltd

Active in EUDAMED

United Kingdomfrom SRN EUDAMED FDA SRN GB-MF-000004429 FEI 3015492990

Devices
9
Registrations
EUDAMEDFDA
FDA recalls
2

At a glance

Counted by deviCERTS from registry records

EU certificates

1 of 1 in force.

See certificates

Market reach

European Union
EUDAMED actor, 1 certificate
United States
FDA establishment, FDA recalls
Authorised rep.
Oxford Immunotec (Ireland) LtdIE
Authorised rep.
Wallac OyFI

Catalogue9

Newest first, rows 1-9 of 9

  • T-Spot.tb Ref TB.300

    Class C
    Active CE IVDR EUDAMED C

  • Leucosep tubes Ref LTK.615

    Class A
    Active CE IVDR EUDAMED A

  • T-Cell Xtend Ref TTK.610

    Class A
    Active CE IVDR EUDAMED A

  • AIM-V Medium Ref AV.200/50 (A18398SA)

    IVD General
    Active CE IVDD EUDAMEDGUDID IVD General

  • T-Cell Select Ref TSK.910

    Class A
    Active CE IVDR EUDAMED A

  • AIM-V Medium Ref AV.200/500 (A18398DJ)

    IVD General
    Active CE IVDD EUDAMEDGUDID IVD General

  • T-Spot.cmv Ref CMV.400

    IVD General
    Active CE IVDD EUDAMED IVD General

  • T-Spot.covid Ref COV.435/300

    IVD General
    Active CE IVDD EUDAMED IVD General

  • T-Spot .tb Test Ref P070006

    Class III
    Active CE IVDD PMA PMA III

Company details

EUDAMED SRN
GB-MF-000004429
FDA FEI number
3015492990
EU VAT number
GB201141779
EUDAMED status
Active
EUDAMED registered name
Oxford Immunotec Ltd
EUDAMED abbreviated name
OI Ltd
Registered address
143, Park Drive, OX14 4SE, Abingdon, United Kingdom (ex Northern Ireland)
PRRC contact
Karen Sear(public in EUDAMED)

EUDAMED certificates1

1 certificate1 valid, 0 expiredIVDR 1next expiry 13 Apr 2031

EUDAMED certificates (1)

QMD Services GmbH 2962 1 certificate

  • IQMS/00008/0v001 Issued

    Quality management system EU IVDR

    Issued
    14 Apr 2026
    Expires
    13 Apr 2031

FDA recalls2

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 2
  • 2021 0
  • 2022 0
  • 2023 0
  • 2024 0
  • 2025 0
  • 2026 0

  • 2020

    • 16 Jul 2020 Z-2976-2020 Class III Terminated Incorrect expiration date included in test kit labeling and/or in Substrate component label. Distribution: Worldwide distribution - U.S. Nationwide distribution including in the states of AL, CO, D.C., GA, ID, IN, MD, OH, PA,…
      Full distribution text Worldwide distribution - U.S. Nationwide distribution including in the states of AL, CO, D.C., GA, ID, IN, MD, OH, PA, TN, TX, and VA. The countries of Austria, Belgium, Czech Republic, France, Germany, Italy, Kuwait, Latvia, Netherlands, Philippines, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Turkey, United Kingdom.
    • 16 Jul 2020 Z-2977-2020 Class III Terminated Incorrect expiration date included in test kit labeling and/or in Substrate component label. Distribution: Worldwide distribution - U.S. Nationwide distribution including in the states of AL, CO, D.C., GA, ID, IN, MD, OH, PA,…
      Full distribution text Worldwide distribution - U.S. Nationwide distribution including in the states of AL, CO, D.C., GA, ID, IN, MD, OH, PA, TN, TX, and VA. The countries of Austria, Belgium, Czech Republic, France, Germany, Italy, Kuwait, Latvia, Netherlands, Philippines, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Turkey, United Kingdom.

FDA establishments1

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

  • Oxford Immunotec, Inc. US

Frequently asked questions

How many devices does Oxford Immunotec Ltd have in the registry?

The registry currently lists 9 devices for Oxford Immunotec Ltd. Devices recorded under merged duplicate company entries are counted once.

Which registries list Oxford Immunotec Ltd's devices?

Among its 9 most recently registered devices, Oxford Immunotec Ltd has devices listed in EUDAMED (8 devices), FDA PMA (1 device) and FDA GUDID (2 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Oxford Immunotec Ltd's devices fall under?

Among its 9 most recently registered devices, the classes recorded for Oxford Immunotec Ltd's devices are Class III, IVDR Class A, IVDR Class C and IVD general. Each device page shows its own class and authorisation.

Are there FDA recall records for Oxford Immunotec Ltd?

FDA recall records list 2 recalls initiated by Oxford Immunotec Ltd, the most recent initiated on 2020-07-16. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What EUDAMED certificates are recorded for Oxford Immunotec Ltd?

EUDAMED lists 1 certificate for Oxford Immunotec Ltd (quality management system) under IVDR. 1 is recorded with the status issued. The most recent was issued on 2026-04-14.

What are the newest devices from Oxford Immunotec Ltd in the registry?

The most recently registered devices listed for Oxford Immunotec Ltd include T-SPOT.TB, Leucosep tubes, T-Cell Xtend and AIM-V Medium.

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