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
Genabio Diagnostics Inc.
RA9-E00325
In Commercial Distribution

  • 00860008954862 ()
  • 00860008954824 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
The QuickProfile Covid-19/Influenza A&B Antigen Combo Test is a lateral flow immunoassay intended for the qualitative and differential detection of nucleocapsid protein from SARS-CoV-2, influenza A and influenza B proteins using self-collected anterior nares nasal swab samples from individuals aged 14 years or older. This test is authorized for non-prescription home use with self-collected anterior nares nasal swab samples from individuals aged 14 years or older with symptoms of SARS-CoV-2, influenza A and influenza B within the first 6 days of symptom onset. This test is also authorized for non-prescription home use with adult-collected anterior nasal swab samples from individuals aged 2 years or older with symptoms of SARS-CoV-2, influenza A and influenza B within the first 6 days of symptom onset.
LUMIQUICK DIAGNOSTICS, INC.
71118-1T
In Commercial Distribution

  • 00855636003808 ()
  • 00855636003815 ()
  • 00855636003822 ()
  • 00855636003839 ()
  • 00855636003846 ()
  • 00855636003853 ()
71118-1T

  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
No Description
IHEALTH LAB INC.
ICO-3000
In Commercial Distribution

  • 10856362005903 ()
  • 00856362005906 ()
  • 20856362005900 ()
  • 30856362005907 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
No Description
IHEALTH LAB INC.
ICO-3000
In Commercial Distribution

  • 10856362005897 ()
  • 00856362005890 ()
  • 20856362005894 ()
  • 30856362005891 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
Slim, reusable plastic flip open container Includes 3 latex-free bandages, 2 hand sanitizer packets
EVANS MANUFACTURING, INC.
3518
In Commercial Distribution

  • 00671188000115 ()
3518

  • First aid kit, medicated
No Description
Gary Plastic Packaging Corp.
DS551TC3
In Commercial Distribution

  • 00661948500153 ()
DS551TC3

  • First aid kit, medicated
No Description
Gary Plastic Packaging Corp.
PZ600-A-CK
In Commercial Distribution

  • 00661948011246 ()
PZ600-A-CK

  • First aid kit, medicated
No Description
Gary Plastic Packaging Corp.
TXB5KQ
In Commercial Distribution

  • 00661948008536 ()
TXB5KQ

  • First aid kit, medicated
No Description
Gary Plastic Packaging Corp.
TRB4KD
In Commercial Distribution

  • 00661948008505 ()
TRB4KD

  • First aid kit, medicated
No Description
Gary Plastic Packaging Corp.
TRB3K
In Commercial Distribution

  • 00661948007683 ()
TRB3K

  • First aid kit, medicated
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