Oxford Immunotec L T D

FDA Filings

This page includes the latest FDA filings for Oxford Immunotec L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

Registration Number	3007066822
FEI Number	3007066822
Name	Oxford Immunotec USA Inc.
Owner & Operator	Oxford Immunotec Ltd
Contact Address	94C Milton Park Abingdon GB-OXF Oxfordshire OX14 4RZ GB
Official Correspondent	Benjamen Hamilton 44-1235-442784-987
Registration Status	1
Initial Importer	Y
Registration Expiration	2020-04-25
Registration Address	320 Norwood Park South Norwood Norwood, MA 02062 US
Establishment Type	Complaint File Establishment per 21 CFR 820.198

Registration Number

3005020579

FEI Number

3006017427

Name

OXFORD IMMUNOTEC LTD

Owner & Operator

Oxford Immunotec Ltd

Contact Address

94C Milton Park
Abingdon GB-OXF Oxfordshire OX14 4RZ GB

Official Correspondent

Benjamen Hamilton
44-1235-442784-987

US Agent

Maureen Garner
New World Regulatory Solutions, Inc.
732 7797422
702 5277836
nwrsinc@gmail.com

Importing Logistics Registration

Importer	Oxford Immunotec Inc
Address	5846 Distribution drive Memphis, TN 38141 UNITED STATES
Phone	1 901 4738290
FAX	1 508 4814672
Importer Type	End User

Registration Status

Initial Importer

Registration Expiration

2020-04-25

Registration Address

94C Innovation Drive Miton Park
Abingdon Oxfordshire, OX14 4RZ GB

Establishment Type

Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
PMA P070006S017 OXFORD IMMUNOTEC,LTD.	T-SPOT.TB Test	2021-07-26
PMA P070006S016 OXFORD IMMUNOTEC,LTD.	T-SPOT.TB TEST	2021-03-22
PMA P070006S014 OXFORD IMMUNOTEC,LTD.	T SPOT-TB Test	2020-08-11
PMA P070006S013 OXFORD IMMUNOTEC,LTD.	T SPOT .TB Test	2020-04-03
PMA P070006S012 OXFORD IMMUNOTEC,LTD.	T-SPOT. TB Test	2020-03-03
PMA P070006S011 OXFORD IMMUNOTEC,LTD.	T-SPOT .TB TEST	2013-09-03
PMA P070006S009 OXFORD IMMUNOTEC,LTD.	T-SPOT .TB TEST	2013-06-12
PMA P070006S008 OXFORD IMMUNOTEC,LTD.	T-SPOT .TB TEST	2012-09-05
PMA P070006S006 OXFORD IMMUNOTEC,LTD.	T-SPOT .TB TEST	2012-01-04
PMA P070006S007 OXFORD IMMUNOTEC,LTD.	T-SPOT TB TEST	2011-11-23
PMA P070006S005 OXFORD IMMUNOTEC,LTD.	T-SPOT TB TEST	2011-05-04
PMA P070006S001 OXFORD IMMUNOTEC,LTD.	T-SPOT TB TEST	2010-07-09
PMA P070006S004 OXFORD IMMUNOTEC,LTD.	T-SPOT .TB TEST	2010-03-19
PMA P070006S003 OXFORD IMMUNOTEC,LTD.	T-SPOT TB TEST	2010-03-04
PMA P070006S002 OXFORD IMMUNOTEC,LTD.	T-SPOT .TB TEST	2009-10-22
JCF Oxford Immunotec USA Inc. [Oxford Immunotec Ltd]	Leucosep tubes	2008-09-12
JCF OXFORD IMMUNOTEC LTD	Leucosep tubes	2008-09-12
PMN P070006 \| OJN Oxford Immunotec USA Inc. [Oxford Immunotec Ltd]	T-SPOT.TB Test	2008-08-13
PMN P070006 \| OJN Oxford Immunotec USA Inc. [Oxford Immunotec Ltd]	T-Cell Xtend reagent	2008-08-13
PMN P070006 \| OJN OXFORD IMMUNOTEC LTD	T-SPOT.TB Test	2008-08-13
PMN P070006 \| OJN OXFORD IMMUNOTEC LTD	T-Cell Xtend reagent	2008-08-13
PMA P070006 OXFORD IMMUNOTEC,LTD.	T SPOT-TB TEST	2008-07-30

Related Finance Registrations

NCAGE Code	U0ZK2	OXFORD IMMUNOTEC LTD
CAGE Code	U0ZK2	OXFORD IMMUNOTEC LTD