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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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Fastep COVID-19 Antigen Home Test 25 Test Per Pack
Azure Biotech, Inc.
COV-S23010H25
In Commercial Distribution

  • 00810022630389 ()


  • 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 4 Test Per Pack
Azure Biotech, Inc.
COV-S23010H4
In Commercial Distribution

  • 00810022630365 ()


  • 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
Fastep COVID-19 Antigen Home Test 1 Test Per Pack
Azure Biotech, Inc.
COV-S23010H1
In Commercial Distribution

  • 00810022630310 ()


  • SARS-CoV-1/SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
No Description
WatMIND USA
CARTON-RDB1V10-BIO-Speedy Swab Rapid COVID-19 & FLU A+B Test (1 Test/Box)
In Commercial Distribution

  • 30810172700094 ()


  • 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
VITACOLL, 100 ml
Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft
A9C100
In Commercial Distribution

  • J017A9C1000 ()


  • Resin artificial teeth
Solana SARS-CoV-2 Assay
DIAGNOSTIC HYBRIDS, INC.
Coronavirus
In Commercial Distribution

  • 30014613339656 ()
M313

  • SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)
SARS-CoV-2 Direct Assay
DIAGNOSTIC HYBRIDS, INC.
Coronavirus
In Commercial Distribution

  • 30014613339144 ()
M124

  • SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)
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