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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
SYRINGE CONVENIENCE PACK-1CC L/L
STRADIS MEDICAL LLC
TM.SCP1ML
In Commercial Distribution

  • M752TMSCP1ML5 ()
  • M752TMSCP1ML0 ()
  • M752TMSCP1ML1 ()


  • General-purpose syringe, single-use
FLUID FILTER TRANSFER KIT
STRADIS MEDICAL LLC
TM.FFTK
In Commercial Distribution

  • M752TMFFTK5 ()
  • M752TMFFTK0 ()
  • M752TMFFTK1 ()


  • Fluid transfer set, general-purpose
5CC LUER LOCK SYRINGES
STRADIS MEDICAL LLC
HCT5CC-LL
In Commercial Distribution

  • M752HCT5CCLL0 ()
  • M752HCT5CCLL5 ()
  • M752HCT5CCLL1 ()


  • General-purpose syringe, single-use
Dressing Change Tray
STRADIS MEDICAL, LLC
HCT5040CHG
In Commercial Distribution

  • M752HCT5040CHG5 ()
  • M752HCT5040CHG0 ()
  • M752HCT5040CHG6 ()


  • Wound dressing kit, medicated
6CC SYRINGE KIT
STRADIS MEDICAL LLC
HCT3916-1
In Commercial Distribution

  • M752HCT391612 ()
  • M752HCT391611 ()
  • M752HCT391615 ()
  • M752HCT391610 ()


  • General-purpose syringe, single-use
6CC SYRINGE KIT
STRADIS MEDICAL LLC
HCT3916
In Commercial Distribution

  • M752HCT39161 ()
  • M752HCT39162 ()
  • M752HCT39165 ()
  • M752HCT39160 ()


  • General-purpose syringe, single-use
12CC SYRINGE KIT
STRADIS MEDICAL LLC
HCT3548-2
In Commercial Distribution

  • M752HCT354822 ()
  • M752HCT354821 ()
  • M752HCT354825 ()
  • M752HCT354820 ()


  • General-purpose syringe, single-use
12CC SYRINGE KIT
STRADIS MEDICAL LLC
HCT3548
In Commercial Distribution

  • M752HCT35485 ()
  • M752HCT35482 ()
  • M752HCT35481 ()
  • M752HCT35480 ()


  • General-purpose syringe, single-use
1CC SLIP TIP SYRINGES
STRADIS MEDICAL LLC
HCT1CC-ST
In Commercial Distribution

  • M752HCT1CCST5 ()
  • M752HCT1CCST0 ()
  • M752HCT1CCST1 ()


  • General-purpose syringe, single-use
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