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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 Class Implantable

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36M - Class B 21 White Cap - 36 Metal
Certified Safety Manufacturing, Inc.
K622-010
Not in Commercial Distribution

  • 00766588220109 ()
K622-010

  • First aid kit, medicated
CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid Test POC
CORETESTS, INC.
ACT21001-10
In Commercial Distribution

  • 10850042559656 ()
  • 00850042559659 ()
  • 00850042559512 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid Test POC
CORETESTS, INC.
ACT21001-25
In Commercial Distribution

  • 00850042559635 ()
  • 10850042559632 ()
  • 00850042559512 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test OTC
CORETESTS, INC.
ACT21002-4
In Commercial Distribution

  • 10850042559564 ()
  • 00850042559567 ()
  • 00850042559543 ()


  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test OTC
CORETESTS, INC.
ACT21002-2
In Commercial Distribution

  • 10850042559557 ()
  • 00850042559550 ()
  • 00850042559543 ()


  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test OTC
CORETESTS, INC.
ACT21002-5
In Commercial Distribution

  • 10850042559533 ()
  • 00850042559536 ()
  • 00850042559543 ()


  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
  • SARS-CoV-2 antigen IVD, kit, rapid ICT, self-testing
CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test OTC
CORETESTS, INC.
ACT21002-1
In Commercial Distribution

  • 00850042559529 ()
  • 10850042559526 ()


  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
  • 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
Genabio Diagnostics Inc.
RA9-E02501
In Commercial Distribution

  • 00810143620092 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
No Description
Genabio Diagnostics Inc.
RA9-E02401
In Commercial Distribution

  • 00810143620085 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
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