FDA.reportPublic FDA data

T-SPOT®.TB96

Primary DI
15051716000008
Brand
T-SPOT®.TB96
Company
OXFORD IMMUNOTEC LIMITED
Model
TB.200
Catalog number
TB.200US
Device description
For the detection of effector t cells that respond to stimulation by mycobacterium tuberculosis antigens esat-6 and cfp-10 and indicated for use as an aid in the diagnosis of m.Tuberculosis infection in conjunction with risk assesment, radiography and other medical diagnostic evaluations.
Published
2015-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OJNMycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJNMycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot TestUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P070006011

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P070006011T SPOT-TB TESTOxford Immunotec, Ltd.2008-07-30OJN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15051716000008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1505171600000815051716000008

GMDN Terms#

Term, Definition table
TermDefinition
Mycobacterium tuberculosis complex species antigen IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from bacterial species of the Mycobacterium tuberculosis complex (M. tuberculosis, M. bovis, M. bovis Bacillus Calmette-Guerin, M. africanum, M. canetti, M. microti, M. caprae and M. pinnipedi) in a clinical specimen and/or culture isolate, using an enzyme immunoassay (EIA) method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
+44 1235442780jpullen@oxfordimmunotec.com

Regulatory Flags#

DUNS number
641127308
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05051716000131T-Cell Select®TSK.960TSK.9602026-01-15
05051716000544Leucosep TubesLTK.615 USLTK.615 US2023-03-31
05051716000087Leucosep TubesLTK.615LTK.6152023-02-07
05051716000155AIM-V MediumAV.200/500AV.200/5002023-02-07
05051716000162AIM-V MediumAV.200/50AV.200/502023-02-07
05051716000186T-Cell Select®TSK.910TSK.910US2023-02-07
15051716000022T.Cell Xtend®TTK.610TTK.610US2014-08-12
15051716000046T-SPOT®.TB50TB.50TB.50US2014-08-12
15051716000053T.Cell Xtend®TTK.650TTK.650US2014-08-12
15051716000305T-SPOT®.TB8TB.300TB.300US2014-08-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05051716000131T-Cell Select®OXFORD IMMUNOTEC LIMITEDOJN2026-01-15
05051716000186T-Cell Select®OXFORD IMMUNOTEC LIMITEDOJN2023-02-07
15051716000022T.Cell Xtend®OXFORD IMMUNOTEC LIMITEDOJN2014-08-12
15051716000046T-SPOT®.TB50OXFORD IMMUNOTEC LIMITEDOJN2014-08-12
15051716000053T.Cell Xtend®OXFORD IMMUNOTEC LIMITEDOJN2014-08-12
15051716000305T-SPOT®.TB8OXFORD IMMUNOTEC LIMITEDOJN2014-08-12