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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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V-Trak
MICROVENTION INC.
100512CC-V
In Commercial Distribution

  • 00811425025659 ()

  • 5 mm x 12 cm
100512CC-V

  • Adenovirus immunoglobulin A (IgA) antibody IVD, calibrator
V-Trak
MICROVENTION INC.
100410CC-V
In Commercial Distribution

  • 00811425025642 ()

  • 4 mm x 10 cm
100410CC-V

  • Adenovirus immunoglobulin A (IgA) antibody IVD, calibrator
V-Trak
MICROVENTION INC.
100307CC-V
In Commercial Distribution

  • 00811425025635 ()

  • 3 mm x 7 cm
100307CC-V

  • Adenovirus immunoglobulin A (IgA) antibody IVD, calibrator
V-Trak
MICROVENTION INC.
100204CC-V
In Commercial Distribution

  • 00811425025628 ()

  • 2 mm x 4 cm
100204CC-V

  • Adenovirus immunoglobulin A (IgA) antibody IVD, calibrator
Strep A Liquid Ctrl
QUIDEL CORPORATION
00354
In Commercial Distribution

  • 30014613003540 ()
00354

  • Beta-haemolytic Group A Streptococcus antigen IVD, control
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
No Description
SEKISUI DIAGNOSTICS, LLC
1011
In Commercial Distribution

  • 00742860100383 ()
  • 10742860100380 ()


  • 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
The Access Inhibin A QC is intended for monitoring system performance of the Access Inhibin A assay.
Beckman Coulter, Inc.
A36100
In Commercial Distribution

  • 15099590203061 ()
A36100

  • Inhibin A IVD, kit, enzyme immunoassay (EIA)
The Access Inhibin A Calibrators are intended to calibrate the Access Inhibin A assay for the quantitative determination of dimeric inhibin A levels 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.
A36098
In Commercial Distribution

  • 15099590203054 ()
A36098

  • Inhibin A IVD, kit, enzyme immunoassay (EIA)
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)
Inhibin A ELISA 1 Plate (96 Tests)
Beckman Coulter, Inc.
DSL-10-28100-1
In Commercial Distribution

  • 15099590180430 ()
DSL-10-28100-1

  • Inhibin A IVD, kit, enzyme immunoassay (EIA)
Inhibin A ELISA 4 Plates (384 Tests)
Beckman Coulter, Inc.
DSL-10-28100-4
In Commercial Distribution

  • 15099590180423 ()
DSL-10-28100-4

  • 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
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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