Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015492990

FEI Number

3015492990

Entity Name

OXFORD IMMUNOTEC LTD

City/State/Country

Abingdon Oxfordshire, GB

Establishment Address

143 Park Drive East, Milton Park, Abingdon Oxfordshire OX14 4SE, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Oxford Immunotec Ltd (Owner Number: 10026700)

Owner / Operator Contact Address

143 Park Drive East, Milton Park, Abingdon, GB-OXF OX14 4SE, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P070006

All Registered Proprietary Names

T-Cell Xtend reagent T-SPOT.TB Test T-Cell Select reagent

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KZI	Culture Media, Enriched	Microbiology	Class 1	866.2330	2016-08-11
OJN	Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test	Unknown	Class 3	N/A	2008-08-13

Official Correspondent

Hannah Gray

US Agent Details

Maureen Garner Business: New World Regulatory Solutions, Inc. Email: nwrsinc@gmail.com Phone: (732) 7797422

Related Public Records

Same Entity

Oxford Immunotec Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0024-05	Remel, Inc.	1	Remel Chocolate Agar, catalog #01301, containing 15 plates/pkg, for in-vitro diagnostic use. The firm name on the label is Remel, Lenexa, KS.

Similar Registrations

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3038136284	CREATIVE LIFE SCIENCE CO., LTD.	Xinzhuang District New Taipei, TW
1210083	ANALYTICHEM USA, INC.	Winslow, ME, US
1530248	OXYRASE, INC.	MANSFIELD, OH, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015492990. Last updated year: 2026. Please use registration number 3015492990 when referencing this establishment in official correspondence.