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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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No Description
RANDOX LABORATORIES LIMITED
LO3999
In Commercial Distribution

  • 05055273204322 ()


  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry
No Description
RANDOX LABORATORIES LIMITED
LO3998
In Commercial Distribution

  • 05055273204315 ()


  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry
No Description
RANDOX LABORATORIES LIMITED
LO8305
In Commercial Distribution

  • 05055273209181 ()


  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry
No Description
RANDOX LABORATORIES LIMITED
LO8015
In Commercial Distribution

  • 05055273209174 ()


  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry
No Description
ACCUTRON, INC.
34063
In Commercial Distribution

  • 00813830021899 ()
34063

  • Medical gas pipeline system
powered muscle stimulator (8 channels) for use as stand-alone device as well as in combination with powered exerciser with predefined programs for stimulation of muscles of the musculoskeletal system
HASOMED GmbH
FES00005
Not in Commercial Distribution

  • 04260397620168 ()
FES00005

  • Physical therapy transcutaneous neuromuscular electrical stimulation system
IB6 recognizes the human CD38 antigen, a single-chain type II transmembrane glycoprotein with enzymatic activity. It is present on the majority of hematopoietic cells, prevalent during early differentiation and activation processes. Terminally differentiated B cells (plasma cells) express CD38 brightly. Furthermore, CD38 is constitutively expressed in several tissues, for example brain, muscle, and kidney.
Miltenyi Biotec B.V. & Co. KG
170-081-002
In Commercial Distribution

  • 04049934134579 ()


  • Assay development analyte-specific reagent IVD
REA103 recognizes human CD185, which is a 42 kDa G-protein-coupled chemokine receptor and is also known as CXCR5, monocyte-derived receptor 15 (MDR15), or Burkitt lymphoma receptor-1 (BLR1). BLR-1 was originally identified on cells of Burkitt lymphoma and B cells. B cell attracting chemokine 1 (BCA-1), also known as B-lymphocyte chemoattractant (BLC) or CXCL13, is the ligand of CD185. It is further expressed on central memory CD4 T cells, T follicular helper cells, and on a migratory population of skin-derived dendritic cells. Additional information: Clone REA103 displays negligible binding to Fc receptors.
Miltenyi Biotec B.V. & Co. KG
170-081-004
In Commercial Distribution

  • 04049934134555 ()


  • Assay development analyte-specific reagent IVD
BW242/412 recognizes the human alpha/beta T cell receptor (TCR). The T cell receptor (TCR) is a heterodimer composed of two transmembrane glycoprotein chains, alpha and beta. Both chains are members of the Ig superfamily and consist of a constant and a polymorphic variable region. The variable region of the TCRalpha/beta is involved in recognition of antigenic peptides presented by the MHC complex of antigen-presenting cells. The Anti-TCRalpha/beta antibody, BW242/412, recognizes a common determinant of the TCRalpha/beta-CD3 complex.
Miltenyi Biotec B.V. & Co. KG
170-081-005
In Commercial Distribution

  • 04049934134548 ()


  • Assay development analyte-specific reagent IVD
The antibody VIT4 is a monoclonal murine IgG2a antibody, which recognizes the human CD4 antigen which is highly expressed on human T helper cells and thymocytes, and at lower levels on monocytes and dendritic cells. It is responsible for the recognition of the MHC Class II antigen.
Miltenyi Biotec B.V. & Co. KG
170-081-007
In Commercial Distribution

  • 04049934134524 ()


  • Assay development analyte-specific reagent IVD
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