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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No Description
Azure Biotech, Inc.
COV-S35002H4
In Commercial Distribution

  • 00810022630433 ()


  • SARS-CoV-1/SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
No Description
Azure Biotech, Inc.
COV-S35002H1
In Commercial Distribution

  • 00810022630419 ()


  • SARS-CoV-1/SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
Fastep COVID-19 Antigen Home Test 5 Test Per Pack
Azure Biotech, Inc.
COV-S23010H5
In Commercial Distribution

  • 00810022630372 ()


  • SARS-CoV-1/SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
Fastep COVID-19 Antigen Home Test 2 Test Per Pack
Azure Biotech, Inc.
COV-S23010H2
In Commercial Distribution

  • 00810022630358 ()


  • SARS-CoV-1/SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
VITACOLL, 100 ml
Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft
A9C100
In Commercial Distribution

  • J017A9C1000 ()


  • Resin artificial teeth
No Description
WatMIND USA
CARTON-RDB1V10-SAN-Speedy Swab Rapid COVID-19 & FLU A+B Test (1 Test/Box)
In Commercial Distribution

  • 40810172700091 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
No Description
WatMIND USA
CARTON-RDB2V6-SAN-Speedy Swab Rapid COVID-19 & FLU A+B Test (2 Tests/Box)
In Commercial Distribution

  • 40810172700084 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
No Description
WatMIND USA
CARTON-RDB2V6-BIO-Speedy Swab Rapid COVID-19 & FLU A+B Test (2 Tests/Box)
In Commercial Distribution

  • 30810172700087 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
EliA SARS-CoV-2-Sp1 IgG Well
Phadia AB
DECC066630
In Commercial Distribution

  • 07333066021201 ()
  • 07333066021287 ()
DECC066630

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
EliA CoV Positive Control C1 250
Phadia AB
83-0042-11
In Commercial Distribution

  • 07333066021263 ()
  • 07333066021232 ()
83-0042-11

  • Plasma protein IVD, control
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