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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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Test Cassettes (25), 2.5mL Buffer Bottles (2), Droppers (25)
Acon Laboratories, Inc.
L031-11711
In Commercial Distribution

  • 20682607200973 ()
  • 00682607200979 ()
  • 00682607002269 ()
200979

  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical
Mechanical Diaper Scale
Pelstar, LLC
YG500R
In Commercial Distribution

  • 00854896003641 ()


  • Laboratory scale, mechanical
No Description
ALERE SAN DIEGO, INC.
01P53-25
Not in Commercial Distribution

  • 10815845020079 ()
  • 00815845020072 ()


  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, rapid ICT, clinical
No Description
ALERE SAN DIEGO, INC.
92405
Not in Commercial Distribution

  • 10815845020048 ()
  • 00815845020041 ()


  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, rapid ICT, clinical
Qualitative immunoassy of the detection of anti-helicobacter pylori antibodies
Immunostics Company, Inc
IHP-30
In Commercial Distribution

  • 20722355002020 ()
  • 10722355002023 ()
  • 80722355002022 ()


  • Helicobacter pylori IgG antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test
Qualitative immunoassy of the detection of anti-helicobacter pylori antibodies
Immunostics Company, Inc
IHP-10
In Commercial Distribution

  • 20722355002013 ()
  • 10722355002016 ()
  • 80722355002015 ()


  • Helicobacter pylori IgG antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test
COVID-19 IgG/IgM Test Cassette (Whole Blood/Serum/Plasma)
BTNX Inc
COV-13C25
In Commercial Distribution

  • 10722066005115 ()
  • 00722066005118 ()


  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical
Mechanical Dial Scale
Pelstar, LLC
386KGS-01
In Commercial Distribution

  • 00892076002312 ()


  • Laboratory scale, mechanical
A in vitro diagnostic test for the qualitative detection of IgG/IgM antibodies against SARS-CoV-2 virus using human blood/serum/plasma samples.
NANO-DITECH CORPORATION
MD8145
In Commercial Distribution

  • 10895160002660 ()
  • 00895160002663 ()


  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical
Mechanical Dial Scale
Pelstar, LLC
386S01
In Commercial Distribution

  • 00892076002305 ()


  • Laboratory scale, mechanical
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