SEARCH RESULTS FOR: (*Imitation Laguna College of Art*)(9245 results)

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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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Non-prescription home use for the qualitative detection of nucleocapsid protein antigen from the SARS-CoV-2 virus with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older or adult collected anterior nasal (nares) swab samples from individuals aged 2 years or older. This test is authorized for individuals with symptoms of COVID-19 within the first 5 days of symptom onset when tested at least twice over three days with at least 48 hours between tests, and for individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested at least three times over five days with at least 48 hours between tests. For use under an emergency use authorization (EUA) only.
Genbody Inc.
COVAGHT2-U-5
In Commercial Distribution

  • 08800076700758 ()
  • 08800076700727 ()
COVAGHT2-U-05

  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
Non-prescription home use for the qualitative detection of nucleocapsid protein antigen from the SARS-CoV-2 virus with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older or adult collected anterior nasal (nares) swab samples from individuals aged 2 years or older. This test is authorized for individuals with symptoms of COVID-19 within the first 5 days of symptom onset when tested at least twice over three days with at least 48 hours between tests, and for individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested at least three times over five days with at least 48 hours between tests. For use under an emergency use authorization (EUA) only.
Genbody Inc.
COVAGHT2-U-25
In Commercial Distribution

  • 08800076700765 ()
  • 08800076700598 ()
COVAGHT2-U-25

  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
Alinity s Sample Cups
ABBOTT LABORATORIES
03R0101
In Commercial Distribution

  • 00380740129613 ()
  • 00380740177881 ()
03R0101

  • Assay container IVD, single-use
No Description
Genabio Diagnostics Inc.
N/A
In Commercial Distribution

  • 00810143620184 ()
  • 81014362018400 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
Pre-aliquoted 96-well PCR plate. Each well contains a 20µL lyophilized triplex reaction. Assay only.
Biomeme, Inc.
1
In Commercial Distribution

  • 10810096640090 ()
  • 00810096640093 ()
3000634

  • Nucleic acid amplification mastermix reagent IVD
Pre-aliquoted 96-well PCR plate. Each well contains a 20µL lyophilized triplex reaction. Kit includes RNA Process Control (RPC) Kit.
Biomeme, Inc.
1
In Commercial Distribution

  • 10810096640083 ()
  • 00810096640086 ()
3000562

  • Nucleic acid amplification mastermix kit IVD
RNA Process Control for Biomeme's SARS-CoV-2 assay form factors (Go-Strips, Go-Plate, or Bulk Vials)
Biomeme, Inc.
1
In Commercial Distribution

  • 10810096640076 ()
  • 00810096640079 ()
3000627

  • Exogenous DNA/RNA internal control IVD, kit
Void Filling Caps for sealing Biomeme PCR Go-Strips during thermocycling. Caps only.
Biomeme, Inc.
1
In Commercial Distribution

  • 10810096640069 ()
  • 00810096640062 ()
3000520

  • SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)
Pre-aliquoted 3-well PCR strips. Each well contains a 20µL lyophilized triplex reaction. Assay only.
Biomeme, Inc.
1
In Commercial Distribution

  • 10810096640052 ()
  • 00810096640055 ()
3000633

  • Nucleic acid amplification mastermix reagent IVD
Pre-aliquoted 3-well PCR strips. Each well contains a 20µL lyophilized triplex reaction. Kit includes RNA Process Control (RPC) Kit and Void Filling Caps.
Biomeme, Inc.
1
In Commercial Distribution

  • 10810096640045 ()
  • 00810096640048 ()
3000555

  • Nucleic acid amplification mastermix kit IVD
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