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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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No Description
SEKISUI DIAGNOSTICS, LLC
1011
In Commercial Distribution

  • 00742860100383 ()
  • 10742860100380 ()


  • Influenza A/B virus antigen IVD, control
Acucy Influenza A&B Test Kit
SEKISUI DIAGNOSTICS, LLC
1010
In Commercial Distribution

  • 00742860100376 ()
  • 10742860100373 ()


  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
No Description
SEKISUI DIAGNOSTICS, LLC
1031
Not in Commercial Distribution

  • 00742860100345 ()


  • Optical laboratory instrument performance standard calibrator/control IVD, reusable
No Description
SEKISUI DIAGNOSTICS, LLC
1039
Not in Commercial Distribution

  • 00742860100338 ()


  • Photometric/spectroscopic immunoassay analyser IVD
OSOM Ultra Flu Aspirate 25T Kit
SEKISUI DIAGNOSTICS, LLC
1007
In Commercial Distribution

  • 00742860100239 ()
  • 10742860100236 ()
1007

  • Nasopharyngeal aspirate container IVD
OSOM Ultra Flu A&B 25T Kit
SEKISUI DIAGNOSTICS, LLC
1006
In Commercial Distribution

  • 00742860100222 ()
  • 10742860100229 ()
1006

  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
The Silaris Dock is an electronic module which executes in vitro diagnostic tests on compatible Silaris Test Cassettes. It consists of an electro-mechanical interface to a single Test Cassette. The Dock contains all electrical systems, controls and logic necessary to orchestrate in-vitro diagnostic tests within the inserted Test Cassette.
MESA BIOTECH, INC.
1026
In Commercial Distribution

  • B54010260 ()
1026

  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care
Polyclonal Rabbit Anti-Human IgA/HRP
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
P0216
In Commercial Distribution

  • 05700572007388 ()

  • Total Volume: 2 Milliliter


  • Total immunoglobulin A (IgA total) IVD, antibody
Polyclonal Rabbit Anti-Human IgA/FITC
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
F0204
In Commercial Distribution

  • 05700572002543 ()

  • Total Volume: 2 Milliliter


  • Total immunoglobulin A (IgA total) IVD, antibody
Polyclonal Rabbit Anti-Human IgA
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
A0262
In Commercial Distribution

  • 05700572001140 ()

  • Total Volume: 1 Milliliter


  • Total immunoglobulin A (IgA total) IVD, antibody
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