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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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Boson - Rapid SARS-CoV-2 Antigen Test Card - 20 Tests/Kit - 06921963712523

Non-prescription home use for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 for individuals with symptoms of COVID-19 within the first 6 days of symptom onset, or individuals without symptoms or other epidemiological reasons to suspect COVID-19.
Xiamen Boson Biotech Co., Ltd.
1N40C5-20-US
In Commercial Distribution

  • 06921963715258 ()
  • 06921963712523 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing

Boson - Rapid SARS-CoV-2 Antigen Test Card - 2 Tests/Kit - 06921963712509

Non-prescription home use for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 for individuals with symptoms of COVID-19 within the first 6 days of symptom onset, or individuals without symptoms or other epidemiological reasons to suspect COVID-19.
Xiamen Boson Biotech Co., Ltd.
1N40C5-2-US
In Commercial Distribution

  • 06921963712509 ()
  • 06921963715258 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing

ACON SARS-CoV-2 IgG/IgM Rapid Test - 00682607200979

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

OSOM Flu SARS-CoV-2 Combo Control Kit - 00742860000072

OSOM Flu SARS-CoV-2 Combo Control Kit
SEKISUI DIAGNOSTICS, LLC
1079
In Commercial Distribution

  • 00742860000072 ()
  • 50742860100678 ()
  • 10742860000079 ()


  • Multiple-genus respiratory virus antigen IVD, control

OSOM COVID-19 Antigen Rapid Test - 00742860000027

OSOM COVID-19 Antigen Rapid Test
SEKISUI DIAGNOSTICS, LLC
1066-40
In Commercial Distribution

  • 00742860000027 ()
  • 10742860000024 ()
1066-40

  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical

OSOM Flu SARS-CoV-2 Combo Home - 00742860000089

OSOM Flu SARS-CoV-2 Combo Home
SEKISUI DIAGNOSTICS, LLC
1074
In Commercial Distribution

  • 00742860000089 ()
  • 50742860100654 ()
  • 10742860100656 ()
1074

  • Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, self-testing

OSOM COVID-19 Antigen Home Test - 00742860000041

OSOM COVID-19 Antigen Home Test
SEKISUI DIAGNOSTICS, LLC
1067-40
In Commercial Distribution

  • 00742860000041 ()
  • 10742860000000 ()
1067-40

  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing

OSOM COVID-19 Antigen Control Kit - 00742860000034

OSOM COVID-19 Antigen Control Kit
SEKISUI DIAGNOSTICS, LLC
1068
In Commercial Distribution

  • 00742860000034 ()
  • 10742860000031 ()
1068

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

Genabio - 06942468181683

Genabio COVID-19 Rapid Self-Test Kit
Core Technology Co.,Ltd.
BP291-5
In Commercial Distribution

  • 06942468183007 ()
  • 06942468181683 ()
  • 16942468181680 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing

Genabio - 06942468181676

Genabio COVID-19 Rapid Self-Test Kit
Core Technology Co.,Ltd.
BP291-1
In Commercial Distribution

  • 06942468183007 ()
  • 06942468181676 ()
  • 16942468181673 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
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