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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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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
VIROCLEAR SARS-CoV-2 (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
200505
In Commercial Distribution

  • 03610522207930 ()
200505

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control
  • SARS-CoV-2 total antibody IVD, control
VIROCLEAR SARS-CoV-2 (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
200500
In Commercial Distribution

  • 03610522207923 ()
200500

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control
  • SARS-CoV-2 total antibody IVD, control
VIROTROL SARS-CoV-2 (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
200305C
In Commercial Distribution

  • 03610522207893 ()
200305C

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control
  • SARS-CoV-2 total antibody IVD, control
VIROTROL SARS-CoV-2 (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
200305B
In Commercial Distribution

  • 03610522207886 ()
200305B

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control
  • SARS-CoV-2 total antibody IVD, control
VIROTROL SARS-CoV-2 (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
200305A
In Commercial Distribution

  • 03610522207879 ()
200305A

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control
  • SARS-CoV-2 total antibody IVD, control
VIROTROL SARS-CoV-2 (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
200300C
In Commercial Distribution

  • 03610522207862 ()
200300C

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control
  • SARS-CoV-2 total antibody IVD, control
VIROTROL SARS-CoV-2 (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
200300B
In Commercial Distribution

  • 03610522207855 ()
200300B

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control
  • SARS-CoV-2 total antibody IVD, control
VIROTROL SARS-CoV-2 (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
200300A
In Commercial Distribution

  • 03610522207848 ()
200300A

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control
  • SARS-CoV-2 total antibody IVD, control
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