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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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TUBE,GASTROSTOMY,22FR,3-PORT,WHITE,1/CS
MEDLINE INDUSTRIES, INC.
DYND70322
In Commercial Distribution

  • 10080196837915 ()

  • 15 CUBIC CENTIMETERS IN VOLUME; 22 FRENCH
DYND70322

  • Gastrostomy tube Y-piece connector
TUBE,GASTROSTOMY,16FR,3-PORT,WHITE,1/CS
MEDLINE INDUSTRIES, INC.
DYND70316
In Commercial Distribution

  • 50080196837890 ()
  • 10080196837892 ()

  • 15 CUBIC CENTIMETERS IN VOLUME; 16 FRENCH
DYND70316

  • Gastrostomy tube Y-piece connector
HOOK,AMNIO,PLASTIC,STERILE
MEDLINE INDUSTRIES, INC.
DYNJ04230
In Commercial Distribution

  • 40080196820765 ()
  • 10080196820764 ()
DYNJ04230

  • Low-pressure tubing connector, single-use, sterile
The ZEUS IFA Epstein-Barr Virus Nuclear Antigen (EBV-NA) anti-complement immunofluorescence (ACIF) Test System is a relatively rapid and sensitive method for the qualitative and semi-quantitative detection of antibodies to the nuclear antigen of Epstein-Barr virus in human sera. When performed according to instructions, this assay can provide information on infectious mononucleosis (IM) that may be of value in patient management and treatment. This device is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
FA9153
In Commercial Distribution

  • 00845533001625 ()
FA9153

  • Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
The ZEUS AtheNA Multi-Lyte® Rheumatoid Factor (RF) IgM Plus Test System is intended for the qualitative and/or quantitative detection of RF IgM class antibody. The test system is intended to be used as an aid in the diagnosis of rheumatoid arthritis. This test is for In Vitro diagnostic use only.
ZEUS SCIENTIFIC, INC.
A91101M
In Commercial Distribution

  • 00845533000086 ()
A91101M

  • Multiple rheumatoid arthritis-associated antibody IVD, kit, multiplex
The ZEUS AtheNA Multi-Lyte® Epstein-Barr Virus (EBV) IgG Plus Test System is intended for the qualitative detection of IgG class antibody to three separate EBV Antigens (EBV-VCA gp-125, total EBV-EA, and recombinant EBNA-1) in human serum using the AtheNA Multi-Lyte System. The test system is intended to be used as an aid in the laboratory diagnosis of EBV-associated infectious mononucleosis and to provide epidemiological information on the disease caused by Epstein-Barr Virus. Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients, cord blood, neonatal specimens, or infants. Assay performance characteristics have not been established for the diagnosis of nasopharyngeal carcinoma, Burkitt's lymphoma, and other EBV-associated lymphomas. This test is for In Vitro diagnostic use only.
ZEUS SCIENTIFIC, INC.
A92101G
In Commercial Distribution

  • 00845533000031 ()
A92101G

  • Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
The ZEUS AtheNA Multi-Lyte® Autoimmune Vasculitis (AIV) Plus Test System is intended for the qualitative and semi-quantitative detection of IgG class antibody to three separate antigens; Glomerular Basement Membrane (GBM), Myeloperoxidase (MPO) and Proteinase 3(PR-3) in human serum. The test system is intended to be used as an aid in the diagnosis of various autoimmune vasculitic disorders characterized by elevated levels of selected autoantibodies. MPO and/or PR-3 may be associated with autoimmune disorders such as Wegener’s Granulomatosis, ICGN, MPA and PRS. Anti-GBM antibodies aid in the diagnosis of Goodpasture’s syndrome. This test is for In Vitro diagnostic use only.
ZEUS SCIENTIFIC, INC.
A96101
In Commercial Distribution

  • 00845533000024 ()
A96101

  • Multiple vasculitis-associated antibody IVD, kit, multiplex
The ZEUS AtheNA Multi-Lyte® ANA-II Plus Test System is intended for the semi-quantitative detection of IgG class antibody to eight separate analytes (SSA, SSB, Sm, RNP, Scl-70, Jo-1, Centromere B, and Histone) in human serum, the quantitative detection of IgG class antibody to dsDNA in human serum, and the qualitative detection of IgG class antibody to ANA. The test system is intended to be used as an aid in the diagnosis of various systemic autoimmune disorders. This test is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
A21101
In Commercial Distribution

  • 00845533000017 ()
A21101

  • Multiple antinuclear antibody (ANA) screening IVD, kit, multiplex
DRAPE,PACEMAKER
MEDLINE INDUSTRIES, INC.
DYNJCD0007
In Commercial Distribution

  • 40080196311041 ()
  • 10080196311040 ()
DYNJCD0007

  • Patient surgical drape, single-use, non-sterile
CLAMP,CIRCUMCISION,1.3CM,NONSTERILE
MEDLINE INDUSTRIES, INC.
MDS10781
In Commercial Distribution

  • 10080196301904 ()
MDS10781

  • Circumcision clamp, single-use
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