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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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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)
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)
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)
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)
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)
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*0201 / NLVPMVATV / PE
In Commercial Distribution

  • 05714183000041 ()
WB02132A PE 50

  • T lymphocyte IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)
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*0101 / VTEHDTLLY / PE
In Commercial Distribution

  • 05714183000034 ()
WA02131A PE 50

  • T lymphocyte IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)
The Dextramer® CMV Kit comprises :; HLA-A*0101 / VTEHDTLLY / PE; HLA-A*0201 / NLVPMVATV / PE; HLA-B*0702 / TPRVTGGGAM / PE; HLA-B*0801 / ELRRKMMYM / PE;HLA-B*3501 / IPSINVHHY / PE Negative control / PE; Anti-CD8/FITC; Anti-CD3/PerCP; Anti-CD4/PE The Dextramer CMV Kit accurately enumerates CMV-specific T cells in blood samples. Dextramer® CMV Kit is a semi-quantitative assay intended for the identification and enumeration of cytomegalovirus (CMV)-specific CD8+ T cells in anticoagulated (Na Heparin) whole blood specimens by flow cytometry. Dextramer® CMV Kit is indicated for assessment of CMV-specific immune status and risk of CMV reactivation in adult human stem cell transplant patients following immunosuppression and used in conjunction with other laboratory and clinical findings. The kit cannot be used to measure CMV infection or disease.
Immudex ApS
CX02
In Commercial Distribution

  • 05714183000010 ()
CX02

  • T lymphocyte IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)
Quick Cure is intended for use as a light cure bracket adhesive. This is a 5gm Push Syringe of Thin Viscosity Paste.
RELIANCE ORTHODONTIC PRODUCTS INC
QCT
Not in Commercial Distribution

  • D798QCT0 ()
QCT

  • Orthodontic bracket adhesive
Band-Lok® is a two paste dual-cure adhesive intended for use as a band cement. This is the Self Mixing Kit that includes 60 self mixing tips. The adhesive is natural shade.
RELIANCE ORTHODONTIC PRODUCTS INC
SMBLK
Not in Commercial Distribution

  • D798SMBLK0 ()
SMBLK

  • Dental composite resin
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