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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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QkVue InLine Strep A Ctrl Set
QUIDEL CORPORATION
00345
In Commercial Distribution

  • 30014613003458 ()
00345

  • Beta-haemolytic Group A Streptococcus antigen IVD, control
No Description
SEKISUI DIAGNOSTICS, LLC
1034
In Commercial Distribution

  • 10742860100403 ()
  • 00742860100406 ()


  • Influenza A/B virus antigen IVD, control
OSOM Ultra Flu A&B Controls 5 Test
SEKISUI DIAGNOSTICS, LLC
1005
In Commercial Distribution

  • 00742860100215 ()
  • 10742860100212 ()
1005

  • Influenza A/B virus antigen IVD, control
No Description
SEKISUI DIAGNOSTICS, LLC
191
Not in Commercial Distribution

  • 00742860100147 ()
  • 10742860100144 ()
191

  • Influenza A/B virus antigen IVD, control
No Description
SEKISUI DIAGNOSTICS, LLC
1011
In Commercial Distribution

  • 00742860100383 ()
  • 10742860100380 ()


  • Influenza A/B virus antigen IVD, control
Rabbit Monoclonal Anti-Human IgA (170), 0.1 mL concentrated
Epitomics Inc.
AC-0147A
In Commercial Distribution

  • 00810113063850 ()

  • Total Volume: 0.1 Milliliter


  • Total immunoglobulin A (IgA total) IVD, antibody
Tinted Liquid
JBC and Company
A
In Commercial Distribution

  • D851A00 ()
A

  • Dental appliance fabrication material, resin
Xpect Flu A&B KT/20TST
REMEL, INC.
R24600
In Commercial Distribution

  • 30848838027032 ()
  • 00848838027031 ()


  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
iotaSOFT Plus Drive Unit
Iotamotion, Inc.
IM-05
In Commercial Distribution

  • 00850002960068 ()


  • Robotic surgical system application software
iotaSOFT Control Console
Iotamotion, Inc.
IM-01
In Commercial Distribution

  • 00850002960051 ()


  • Robotic surgical system application software
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