T-SPOT.TB TEST

FDA Premarket Approval P070006 S016

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

A scale up of batch size for device components

DeviceT-SPOT.TB TEST
Generic NameMycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-linked Immunospot Test
ApplicantOXFORD IMMUNOTEC,LTD.
Date Received2021-03-09
Decision Date2021-03-22
PMAP070006
SupplementS016
Product CodeOJN 
Advisory CommitteeMicrobiology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address OXFORD IMMUNOTEC,LTD. 94c Innovation Drive milton Park, Abingdon Oxfordshire OX14

Supplemental Filings

Supplement NumberDateSupplement Type
P070006Original Filing
S016 2021-03-09 30-day Notice
S015
S014 2020-03-30 Normal 180 Day Track
S013 2020-03-10 30-day Notice
S012 2019-12-05 Real-time Process
S011 2013-02-19 135 Review Track For 30-day Notice
S010
S009 2012-09-04 135 Review Track For 30-day Notice
S008 2012-08-27 Real-time Process
S007 2011-11-17 Real-time Process
S006 2011-07-12 Normal 180 Day Track
S005 2011-04-06 30-day Notice
S004 2010-02-18 30-day Notice
S003 2009-10-01 Real-time Process
S002 2009-09-30 30-day Notice
S001 2009-02-27 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
15051716000053 P070006 006
15051716000022 P070006 006
15051716000046 P070006 007
15051716000305 P070006 011
15051716000008 P070006 011

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