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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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CMV Negative Control - B110CMN20100

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

Mumps Negative Control - B110MUN80100

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

LT Blood Cross Matching Card - 06974621793150

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

LT Blood Cross Matching Card - 06974621793143

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

CLIAWAIVED INC - 00183278000443

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

CLIAWAIVED INC - 00183278000436

CoronaChek COVID-19 IgG/IgM Rapid Test Cassette (25 per pk) includes 25 droppers, 1 buffer, 1 insert, 1 procedure card)
Cliawaived, Inc.
CLIA-INGM-MC42
In Commercial Distribution

  • 00183278000436 ()
CLIA-INGM-MC42

  • 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

PRIMO - 00840216117655

G&G ANGLED WEDGE BUNDLE BARIATRIC
Asp Global, LLC
GGTS08B
In Commercial Distribution

  • 00840216117655 ()


  • Freestanding patient positioner, reusable

PRIMO - 00840216117648

G&G ANGLED WEDGE BUNDLE STANDARD
Asp Global, LLC
GGTS08
In Commercial Distribution

  • 00840216117648 ()


  • Freestanding patient positioner, reusable

Trinity Biotech - 05391516748742

EU – Lyme IgM Western Blot, Western Blot Test System for the Detection of IgM Antibodies to Borrelia afzelii “PKO” and Borrelia garinii, 40 Tests
MARDX DIAGNOSTICS, INC.
44-2020M
In Commercial Distribution

  • 05391516748742 ()
44-2020M

  • Multiple Borrelia species immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay

Trinity Biotech - 05391516748735

EU Lyme + VlsE IgG Western Blot, Western Blot Test System for the Detection of IgG Antibodies to Borrelia afzelii “PKO”, Borrelia garinii, and Borrelia burgdorferi VlsE, 40 Tests
MARDX DIAGNOSTICS, INC.
44-2020GV
In Commercial Distribution

  • 05391516748735 ()
44-2020GV

  • Multiple Borrelia species immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay
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