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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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QuickProfile™ 2019-nCoV IgG/IgM Test Card is an immunochromatography based one step in vitro test. It is designed for the rapid qualitative determination of IgG and IgM antibodies to the 2019 novel coronavirus (2019-nCoV, SARS-CoV-2) in human serum, plasma, or whole blood. QuickProfile™ 2019-nCoV IgG/IgM Test Card is a supplemental rapid screening tool for symptomatic or asymptomatic carriers of the virus.
LUMIQUICK DIAGNOSTICS, INC.
71108B
In Commercial Distribution

  • M90171108B1 ()
  • M90171108B0 ()
  • M90171108B2 ()

  • Length: 80 Millimeter
71108B

  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical
COVID-19 IgG/IgM Test Cassette (Whole Blood/Serum/Plasma)
BTNX Inc
COV-13C25
In Commercial Distribution

  • 10722066005115 ()
  • 00722066005118 ()


  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical
A in vitro diagnostic test for the qualitative detection of IgG/IgM antibodies against SARS-CoV-2 virus using human blood/serum/plasma samples.
NANO-DITECH CORPORATION
MD8145
In Commercial Distribution

  • 10895160002660 ()
  • 00895160002663 ()


  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical
Alinity m MPXV Application Specification File
ABBOTT MOLECULAR INC.
09R06-05A
In Commercial Distribution

  • 00884999050778 ()
09R06-05A

  • Laboratory instrument/analyser application software IVD
Alinity m Resp-4-Plex Application Specification File
ABBOTT MOLECULAR INC.
09N79-05E
In Commercial Distribution

  • 00884999050464 ()
09N79-05E

  • Laboratory instrument/analyser application software IVD
Alinity m SARS-CoV-2 Application Specification File
ABBOTT MOLECULAR INC.
09N78-03F
In Commercial Distribution

  • 00884999050457 ()
09N78-03F

  • Laboratory instrument/analyser application software IVD
Alinity m Resp-4-Plex Application Specification File
ABBOTT MOLECULAR INC.
09N79-05D
In Commercial Distribution

  • 00884999050242 ()
09N79-05D

  • Laboratory instrument/analyser application software IVD
Alinity m SARS-CoV-2 Application Specification
ABBOTT MOLECULAR INC.
09N78-03E
In Commercial Distribution

  • 00884999050211 ()
09N78-03E

  • Laboratory instrument/analyser application software IVD
Alinity m SARS COV-2 Application Specification File
ABBOTT MOLECULAR INC.
09N78-03D
In Commercial Distribution

  • 00884999050136 ()
09N78-03D

  • Laboratory instrument/analyser application software IVD
No Description
ABBOTT MOLECULAR INC.
09N79-05C
In Commercial Distribution

  • 00884999050020 ()
09N79-05C

  • Laboratory instrument/analyser application software IVD
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