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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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Echovirus Screen Virus Antigen Substrate, 12 wells, For IFA Test System - B110EC44120

No Description
Bion Enterprises, Ltd.
EC-4412
In Commercial Distribution

  • B110EC44120 ()
EC-4412

  • Multiple enterovirus immunoglobulin G (IgG) antibody IVD, reagent

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

Diamedix - 00817273020181

"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)

Diamedix - 00817273020167

"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)

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

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

Millennium - 00190776183882

Mallet, , dia. , stainless steel, g, g
Avalign Technologies, Inc.
1-FL036R
In Commercial Distribution

  • 00190776183882 ()


  • Surgical mallet

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
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