T-SPOT®.TB50 TB.50US

GUDID 15051716000046

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

Oxford Immunotec, Inc.

Mycobacterium tuberculosis complex species antigen IVD, kit, enzyme immunoassay (EIA) Mycobacterium tuberculosis complex species antigen IVD, kit, enzyme immunoassay (EIA)
Primary Device ID15051716000046
NIH Device Record Keye41cab65-8c23-40c3-bedd-7709d33cbef5
Commercial Distribution StatusIn Commercial Distribution
Brand NameT-SPOT®.TB50
Version Model NumberTB.50
Catalog NumberTB.50US
Company DUNS009744265
Company NameOxford Immunotec, Inc.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS115051716000046 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OJNMycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2014-08-12

Devices Manufactured by Oxford Immunotec, Inc.

05051716000544 - Leucosep Tubes2023-04-10 Leucosep® tubes are intended for use in the collection and separation of peripheral blood mononuclear cells (PBMCs) from whole
05051716000087 - Leucosep Tubes2023-02-15 Leucosep® tubes are intended for use in the collection and separation of peripheral blood mononuclear cells (PBMCs) from whole
05051716000155 - AIM-V Medium2023-02-15 AIM-V® serum free cell culture medium is intended for use in the preparation of peripheral blood mononuclear cells (PBMCs) from
05051716000162 - AIM-V Medium2023-02-15 AIM-V® serum free cell culture medium is intended for use in the preparation of peripheral blood mononuclear cells (PBMCs) from
05051716000186 - T-Cell Select®2023-02-15 The T-SPOT.TB test has been evaluated for the processing of blood samples within 8 hours of venipuncture. With the T-Cell Select
15051716000008 - T-SPOT®.TB962018-07-06 For the detection of effector t cells that respond to stimulation by mycobacterium tuberculosis antigens esat-6 and cfp-10 and i
15051716000022 - T.Cell Xtend®2018-07-06 Approval for the use of t-cell xtend reagent with the t-spot. Tb test, in order to extend the time from sample collection to sam
15051716000046 - T-SPOT®.TB502018-07-06For 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
15051716000046 - T-SPOT®.TB502018-07-06 For the detection of effector t cells that respond to stimulation by mycobacterium tuberculosis antigens esat-6 and cfp-10 and i

Trademark Results [T-SPOT]

Mark Image

Registration | Serial
Company
Trademark
Application Date
T-SPOT
T-SPOT
78437297 3665044 Live/Registered
Oxford Immunotec Limited
2004-06-17
T-SPOT
T-SPOT
77608590 not registered Dead/Abandoned
Edward Abel
2008-11-06
T-SPOT
T-SPOT
77608576 not registered Dead/Abandoned
Edward Abel
2008-11-06
T-SPOT
T-SPOT
75899961 not registered Dead/Abandoned
CASE WESTERN RESERVE UNIVERSITY
2000-01-19
T-SPOT
T-SPOT
75199458 not registered Dead/Abandoned
ATHERSYS, INC.
1996-11-18

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