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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Atellica IM EPO MCM - 00630414245782

Erythropoietin (EPO) - Atellica IM - Master Curve Material Kit 5 x 1 x 1mL
Siemens Healthcare Diagnostics Inc.
10733007
In Commercial Distribution

  • 00630414245782 ()
10733007

  • Erythropoietin (EPO) IVD, control

MHC Dextramer - 05714183000133

Analyte specific reagent. Analytical and performance characteristics are not established. MHC Dextramer® reagent recognizing T cell receptors displayed on surface of human T cells restricted by HLA-A*11:01 with specificity for the KRAS G12V neopeptide: VVGAVGVGK. MHC Dextramer reagents consist of a dextran polymer backbone carrying an optimized number of MHC-peptide complexes and fluorochrome molecules (PE). MHC Dextramer reagents are provided in buffer containing 1% bovine serum albumin (BSA) and 15 mM NaN3, pH 7.2.
Immudex ApS
HLA-A*1101 / VVGAVGVGK / PE
In Commercial Distribution

  • 05714183000133 ()
WD05109A PE 50

  • T lymphocyte IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)

MHC Dextramer - 05714183000126

Analyte specific reagent. Analytical and performance characteristics are not established. MHC Dextramer® reagent recognizing T cell receptors displayed on surface of human T cells restricted by HLA-A*11:01 with specificity for the KRAS G12V neopeptide: VVGAVGVGK. MHC Dextramer reagents consist of a dextran polymer backbone carrying an optimized number of MHC-peptide complexes and fluorochrome molecules (APC). MHC Dextramer reagents are provided in buffer containing 1% bovine serum albumin (BSA) and 15 mM NaN3, pH 7.2.
Immudex ApS
HLA-A*1101 / VVGAVGVGK / APC
In Commercial Distribution

  • 05714183000126 ()
WD05109A AP 50

  • T lymphocyte IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)

CMV Dextramer - 05714183000119

Analyte specific reagent. Analytical and performance characteristics are not established. Negative Dextramers comprise dextran polymer backbone carrying multiple fluorochrome molecules (PE) and multiple MHC I-peptide complexes displaying nonsense peptide. Negative Dextramers are not reactive with T cell receptors of normal human CD8+ T cells. The reagent is provided in liquid form in volumes of 0,5 ml in buffer containing 1% bovine serum albumin (BSA) and 15 mmol/L NaN, pH 7.2.
Immudex ApS
Negative Dextramer / PE
In Commercial Distribution

  • 05714183000119 ()
NI03233A PE 50

  • T lymphocyte IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)

CMV Dextramer - 05714183000102

Analyte specific reagent. Analytical and performance characteristics are not established. CMV Dextramer reagents react with T cell receptors on human CD8+ T cells restricted by the HLA allele of the Dextramer and specific for the CMV peptide displayed. CMV Dextramers comprise dextran polymer backbone carrying multiple fluorochrome molecules (PE) and multiple MHC-peptide complexes displaying a peptide epitope from a CMV antigen. CMV Dextramer reagents are provided in liquid form in volumes of 0,5 ml in buffer containing 1% bovine serum albumin (BSA) and 15 mmol/L NaN, pH 7.2.
Immudex ApS
HLA-B*3501 / IPSINVHHY / PE
In Commercial Distribution

  • 05714183000102 ()
WK02138A PE 50

  • T lymphocyte IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)

CMV Dextramer - 05714183000096

Analyte specific reagent. Analytical and performance characteristics are not established. CMV Dextramer reagents react with T cell receptors on human CD8+ T cells restricted by the HLA allele of the Dextramer and specific for the CMV peptide displayed. CMV Dextramers comprise dextran polymer backbone carrying multiple fluorochrome molecules (PE) and multiple MHC-peptide complexes displaying a peptide epitope from a CMV antigen. CMV Dextramer reagents are provided in liquid form in volumes of 0,5 ml in buffer containing 1% bovine serum albumin (BSA) and 15 mmol/L NaN, pH 7.2.
Immudex ApS
HLA-B*0801 / ELRRKMMYM / PE
In Commercial Distribution

  • 05714183000096 ()
WI02137A PE 50

  • T lymphocyte IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)

CMV Dextramer - 05714183000089

Analyte specific reagent. Analytical and performance characteristics are not established. CMV Dextramer reagents react with T cell receptors on human CD8+ T cells restricted by the HLA allele of the Dextramer and specific for the CMV peptide displayed. CMV Dextramers comprise dextran polymer backbone carrying multiple fluorochrome molecules (PE) and multiple MHC-peptide complexes displaying a peptide epitope from a CMV antigen. CMV Dextramer reagents are provided in liquid form in volumes of 0,5 ml in buffer containing 1% bovine serum albumin (BSA) and 15 mmol/L NaN, pH 7.2.
Immudex ApS
HLA-B*0702 / TPRVTGGGAM / PE
In Commercial Distribution

  • 05714183000089 ()
WH02136A PE 50

  • T lymphocyte IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)

CMV Dextramer - 05714183000072

Analyte specific reagent. Analytical and performance characteristics are not established. CMV Dextramer reagents react with T cell receptors on human CD8+ T cells restricted by the HLA allele of the Dextramer and specific for the CMV peptide displayed. CMV Dextramers comprise dextran polymer backbone carrying multiple fluorochrome molecules (PE) and multiple MHC-peptide complexes displaying a peptide epitope from a CMV antigen. CMV Dextramer reagents are provided in liquid form in volumes of 0,5 ml in buffer containing 1% bovine serum albumin (BSA) and 15 mmol/L NaN, pH 7.2.
Immudex ApS
HLA-B*0702 / RPHERNGFTVL / PE
In Commercial Distribution

  • 05714183000072 ()
WH02135A PE 50

  • T lymphocyte IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)

CMV Dextramer - 05714183000065

Analyte specific reagent. Analytical and performance characteristics are not established. CMV Dextramer reagents react with T cell receptors on human CD8+ T cells restricted by the HLA allele of the Dextramer and specific for the CMV peptide displayed. CMV Dextramers comprise dextran polymer backbone carrying multiple fluorochrome molecules (PE) and multiple MHC-peptide complexes displaying a peptide epitope from a CMV antigen. CMV Dextramer reagents are provided in liquid form in volumes of 0,5 ml in buffer containing 1% bovine serum albumin (BSA) and 15 mmol/L NaN, pH 7.2.
Immudex ApS
HLA-A*2402 / QYDPVAALF / PE
In Commercial Distribution

  • 05714183000065 ()
WF02133A PE 50

  • T lymphocyte IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)

CMV Dextramer - 05714183000058

Analyte specific reagent. Analytical and performance characteristics are not established. CMV Dextramer reagents react with T cell receptors on human CD8+ T cells restricted by the HLA allele of the Dextramer and specific for the CMV peptide displayed. CMV Dextramers comprise dextran polymer backbone carrying multiple fluorochrome molecules (PE) and multiple MHC-peptide complexes displaying a peptide epitope from a CMV antigen. CMV Dextramer reagents are provided in liquid form in volumes of 0,5 ml in buffer containing 1% bovine serum albumin (BSA) and 15 mmol/L NaN, pH 7.2.
Immudex ApS
HLA-A*0301 / KLGGALQAK / PE
In Commercial Distribution

  • 05714183000058 ()
WC02197A PE 50

  • T lymphocyte IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)
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