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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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The Access Inhibin A assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of dimeric inhibin A in human serum and plasma (heparin and EDTA) as an aid in the diagnosis and monitoring of various hormonal reproductive disorders using the Access Immunoassay Systems.
Beckman Coulter, Inc.
A36097
In Commercial Distribution

  • 15099590203047 ()
A36097

  • Inhibin A IVD, kit, enzyme immunoassay (EIA)
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
No Description
SEKISUI DIAGNOSTICS, LLC
1032
In Commercial Distribution

  • 10742860100397 ()
  • 00742860100390 ()


  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
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
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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