FDA.reportPublic FDA data

T-SPOT®.TB8

Primary DI
15051716000305
Brand
T-SPOT®.TB8
Company
Oxford Immunotec, Inc.
Model
TB.300
Catalog number
TB.300US
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
2014-08-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
15051716000305PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1505171600030515051716000305

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
Handling Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
009744265
Device count
1
DM exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

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
15051716000008T-SPOT®.TB96TB.200TB.200US2015-09-15
15051716000022T.Cell Xtend®TTK.610TTK.610US2014-08-12
15051716000046T-SPOT®.TB50TB.50TB.50US2014-08-12
15051716000053T.Cell Xtend®TTK.650TTK.650US2014-08-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05051716000131T-Cell Select®Oxford Immunotec, Inc.OJN2026-01-15
05051716000186T-Cell Select®Oxford Immunotec, Inc.OJN2023-02-07
15051716000008T-SPOT®.TB96Oxford Immunotec, Inc.OJN2015-09-15
15051716000022T.Cell Xtend®Oxford Immunotec, Inc.OJN2014-08-12
15051716000046T-SPOT®.TB50Oxford Immunotec, Inc.OJN2014-08-12
15051716000053T.Cell Xtend®Oxford Immunotec, Inc.OJN2014-08-12