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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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Anti-IgG,-C3d; Polyspecific (Rabbit and Murine Monoclonal) BIOCLONE 100X10ML
ORTHO-CLINICAL DIAGNOSTICS, INC.
716000
In Commercial Distribution

  • 10758750003457 ()
716000

  • Multiple monospecific antihuman globulin/anti-complement cell coat typing IVD, kit, agglutination
No Description
Bion Enterprises, Ltd.
MUN-8010
In Commercial Distribution

  • B110MUN80100 ()
MUN-8010

  • Mumps virus immunoglobulin M (IgM) antibody IVD, control
  • Mumps virus immunoglobulin G (IgG) antibody IVD, control
No Description
Bion Enterprises, Ltd.
CMN-2010
In Commercial Distribution

  • B110CMN20100 ()
CMN-2010

  • Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, control
  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, control
No Description
Bion Enterprises, Ltd.
MEN-6010
In Commercial Distribution

  • B110MEN60100 ()
MEN-6010

  • Measles virus immunoglobulin G (IgG) antibody IVD, control
  • Measles virus immunoglobulin M (IgM) antibody IVD, control
No Description
Bion Enterprises, Ltd.
EC-4412
In Commercial Distribution

  • B110EC44120 ()
EC-4412

  • Multiple enterovirus immunoglobulin G (IgG) antibody IVD, reagent
"720-350 HSV 1&2 IgM Test Kit"
DIAMEDIX CORPORATION
720-350
In Commercial Distribution

  • 00817273020181 ()


  • Multiple Candida species immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, enzyme immunoassay (EIA)
"720-330 CMV IgM Test Kit"
DIAMEDIX CORPORATION
720-330
In Commercial Distribution

  • 00817273020167 ()


  • Multiple Candida species immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, enzyme immunoassay (EIA)
No Description
Zhuhai Longtime Biological Technology Co., Ltd
BCM-8
In Commercial Distribution

  • 06974621793150 ()
  • 16974621793157 ()


  • Multiple monospecific antihuman globulin/anti-complement cell coat typing IVD, kit, agglutination
No Description
Zhuhai Longtime Biological Technology Co., Ltd
BCM-6
In Commercial Distribution

  • 06974621793143 ()
  • 16974621793140 ()


  • Multiple monospecific antihuman globulin/anti-complement cell coat typing IVD, kit, agglutination
CoronaChek COVID-19 IgG/IgM Rapid Test Cassette with CE Mark - Labeled "For Professional Use Only" (Single kit includes 1 device, 1 lancets, 1 dropper, 1 single use buffer, 1 alcohol wipe, 1 procedure card and insert)
Cliawaived, Inc.
CLIA-INGM-MC42S
In Commercial Distribution

  • 00183278000443 ()
CLIA-INGM-MC42S

  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical
  • SARS-CoV-1 immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, rapid ICT, clinical
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