OXFORD IMMUNOTEC LIMITED

GUDID#

T-Cell Select® - The T-SPOT.TB test has been evaluated for the processing of blood samples within 8 hours of venipuncture. With the T-Cell Select reagent kit, blood samples stored or maintained at room temperature (18 – 25 °C) for up to 54 (0 – 54) hours post venipuncture can be used with the T-SPOT.TB test. The T-Cell Select reagent may also enable automation of the cell isolation process and reduce sample separation time relative to preparation via the density gradient separation methodology. With the T-Cell Select reagent kit, blood samples may be shipped and/or stored overnight at room temperature (18 – 25 °C), up to 54 (0 – 54) hours post venipuncture.
OXFORD IMMUNOTEC LIMITED
2026-01-15
Leucosep Tubes - Leucosep® tubes are intended for use in the collection and separation of peripheral blood mononuclear cells (PBMCs) from whole blood. The tubes facilitate the separation of PBMCs from whole blood when using a polysucrose-based gradient separation solution procedure prior to the use of these cells in ELISPOT assays. ELISPOT techniques utilize T cells in PBMCs that have been separated from whole blood. One method for separating these cells requires the use of a poly-sucrose-based gradient separation solution. This procedure involves a number of steps which should be carried out with care to ensure optimal results. The use of Leucosep tubes reduces the number of steps and reduces the amount of time required to perform the separation procedure.
OXFORD IMMUNOTEC LIMITED
2023-03-31
Leucosep Tubes - Leucosep® tubes are intended for use in the collection and separation of peripheral blood mononuclear cells (PBMCs) from whole blood. The tubes facilitate the separation of PBMCs from whole blood when using a polysucrose-based gradient separation solution procedure prior to the use of these cells in ELISPOT assays. ELISPOT techniques utilize T cells in PBMCs that have been separated from whole blood. One method for separating these cells requires the use of a poly-sucrose-based gradient separation solution. This procedure involves a number of steps which should be carried out with care to ensure optimal results. The use of Leucosep tubes reduces the number of steps and reduces the amount of time required to perform the separation procedure.
OXFORD IMMUNOTEC LIMITED
2023-02-07
AIM-V Medium - AIM-V® serum free cell culture medium is intended for use in the preparation of peripheral blood mononuclear cells (PBMCs) from whole blood and for use as a culture medium for in vitro testing using the ELISPOT method. PBMCs, separated from whole blood samples, are washed with AIM-V medium and the cell pellet is re-suspended in the medium. The cells are counted using a haemocytometer or automated cell counter before being diluted to the required concentration in AIM-V.
OXFORD IMMUNOTEC LIMITED
2023-02-07
AIM-V Medium - AIM-V® serum free cell culture medium is intended for use in the preparation of peripheral blood mononuclear cells (PBMCs) from whole blood and for use as a culture medium for in vitro testing using the ELISPOT method. PBMCs, separated from whole blood samples, are washed with AIM-V medium and the cell pellet is re-suspended in the medium. The cells are counted using a haemocytometer or automated cell counter before being diluted to the required concentration in AIM-V.
OXFORD IMMUNOTEC LIMITED
2023-02-07
T-Cell Select® - The T-SPOT.TB test has been evaluated for the processing of blood samples within 8 hours of venipuncture. With the T-Cell Select reagent kit, blood samples stored or maintained at room temperature (18 – 25 °C) for up to 54 (0 – 54) hours post venipuncture can be used with the T-SPOT.TB test. The T-Cell Select reagent may also enable automation of the cell isolation process and reduce sample separation time relative to preparation via the density gradient separation methodology. With the T-Cell Select reagent kit, blood samples may be shipped and/or stored overnight at room temperature (18 – 25 °C), up to 54 (0 – 54) hours post venipuncture.
OXFORD IMMUNOTEC LIMITED
2023-02-07
T-SPOT®.TB96 - 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.
OXFORD IMMUNOTEC LIMITED
2015-09-15
T.Cell Xtend® - 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 sample processing from within 8 hours of venepuncture to between 23 and 30 hours post venepuncture; and to make a technical correction to the t-spot. Tb test package insert to change the number of blood collection tubes required from (2) 6 ml heparin tubes to (1) 6 ml heparin tube. The t-cell xtend reagent is indicated for use with the t-spot. Tb test for the pre-treatment of whole blood prior to lymphocyte separation. The reagent aids in the removal of selected white blood cells from whole blood stored at room temperature (18-25 degrees c).
OXFORD IMMUNOTEC LIMITED
2014-08-12
T-SPOT®.TB50 - 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 assessment, radiography and other medical diagnostic evaluations.
OXFORD IMMUNOTEC LIMITED
2014-08-12
T.Cell Xtend® - 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 sample processing from within 8 hours of venipuncture to between 23 and 30 hours post venipuncture; and to make a technical correction to the t-spot. Tb test package insert to change the number of blood collection tubes required from (2) 6 ml heparin tubes to (1) 6 ml heparin tube. The t-cell xtend reagent is indicated for use with the t-spot. Tb test for the pre-treatment of whole blood prior to lymphocyte separation. The reagent aids in the removal of selected white blood cells from whole blood stored at room temperature (18-25 degrees c).
OXFORD IMMUNOTEC LIMITED
2014-08-12
T-SPOT®.TB8 - 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.
OXFORD IMMUNOTEC LIMITED
2014-08-12