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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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ACCURUN® - 00816784020130

ACCURUN 25 ToRCH IgG Series 5000 3 x 1.0 mL
Lgc Clinical Diagnostics, Inc.
2000-0034
In Commercial Distribution

  • 00816784020130 ()
2000-0034

  • Multiple infectious organism/newborn TORCH screen IVD, control

Diamedix - 00817273020044

"300-371A Rubella IgM Capture Lyoph. Ag. Accessory Kit"
DIAMEDIX CORPORATION
300-371A
In Commercial Distribution

  • 00817273020044 ()


  • Multiple infectious organism/newborn TORCH screen IVD, kit, enzyme immunoassay (EIA)

Nano-CheckTM COVID-19 IgG/IgM Antibody Test - 00895160002663

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

Health o meter professional - 00892076002312

Mechanical Dial Scale
Pelstar, LLC
386KGS-01
In Commercial Distribution

  • 00892076002312 ()


  • Laboratory scale, mechanical

Health o meter professional - 00892076002305

Mechanical Dial Scale
Pelstar, LLC
386S01
In Commercial Distribution

  • 00892076002305 ()


  • Laboratory scale, mechanical

McKesson - 00612479202719

TEST KIT, H PYLORI (10/KT)
MCKESSON MEDICAL-SURGICAL INC.
5007
In Commercial Distribution

  • 00612479240087 ()
  • 00612479202719 ()


  • Helicobacter pylori IgG antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test

McKesson - 00612479202702

TEST KIT, H PYLORI (25/KT)
MCKESSON MEDICAL-SURGICAL INC.
5008
In Commercial Distribution

  • 00612479240070 ()
  • 00612479202702 ()


  • Helicobacter pylori IgG antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test

Clearview® - 10815845020048

No Description
ALERE SAN DIEGO, INC.
92405
Not in Commercial Distribution

  • 10815845020048 ()
  • 00815845020041 ()


  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, rapid ICT, clinical

VIROCLEAR - 03610522207930

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 - 03610522207923

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
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