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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Azur
MICROVENTION INC.
45-080810
In Commercial Distribution

  • 10810170018241 ()
  • 00810170018244 ()

  • 8 mm x 10 cm
45-080810

  • Adenovirus immunoglobulin A (IgA) antibody IVD, calibrator
Azur
MICROVENTION INC.
45-080620
In Commercial Distribution

  • 10810170018234 ()
  • 00810170018237 ()

  • 6 mm x 20 cm
45-080620

  • Adenovirus immunoglobulin A (IgA) antibody IVD, calibrator
Azur
MICROVENTION INC.
45-080614
In Commercial Distribution

  • 10810170018227 ()
  • 00810170018220 ()
45-080614

  • Adenovirus immunoglobulin A (IgA) antibody IVD, calibrator
Azur
MICROVENTION INC.
45-080610
In Commercial Distribution

  • 10810170018210 ()
  • 00810170018213 ()

  • 6 mm x 10 cm
45-080610

  • Adenovirus immunoglobulin A (IgA) antibody IVD, calibrator
Azur
MICROVENTION INC.
45-080606
In Commercial Distribution

  • 10810170018203 ()
  • 00810170018206 ()

  • 6 mm x 6 cm
45-080606

  • Adenovirus immunoglobulin A (IgA) antibody IVD, calibrator
Azur
MICROVENTION INC.
45-080514
In Commercial Distribution

  • 10810170018197 ()
  • 00810170018190 ()

  • 5 mm x 14 cm
45-080514

  • Adenovirus immunoglobulin A (IgA) antibody IVD, calibrator
Azur
MICROVENTION INC.
45-080510
In Commercial Distribution

  • 10810170018180 ()
  • 00810170018183 ()

  • 5 mm x 10 cm
45-080510

  • Adenovirus immunoglobulin A (IgA) antibody IVD, calibrator
Azur
MICROVENTION INC.
45-080506
In Commercial Distribution

  • 10810170018173 ()
  • 00810170018176 ()

  • 5 mm x 6 cm
45-080506

  • Adenovirus immunoglobulin A (IgA) antibody IVD, calibrator
Azur
MICROVENTION INC.
45-080504
In Commercial Distribution

  • 10810170018166 ()
  • 00810170018169 ()

  • 5 mm x 4 cm
45-080504

  • Adenovirus immunoglobulin A (IgA) antibody IVD, calibrator
Azur
MICROVENTION INC.
45-080410
In Commercial Distribution

  • 10810170018159 ()
  • 00810170018152 ()

  • 4 mm x 10 cm
45-080410

  • Adenovirus immunoglobulin A (IgA) antibody IVD, calibrator
Azur
MICROVENTION INC.
45-080406
In Commercial Distribution

  • 10810170018142 ()
  • 00810170018145 ()

  • 4 mm x 6 cm
45-080406

  • Adenovirus immunoglobulin A (IgA) antibody IVD, calibrator
Azur
MICROVENTION INC.
45-080404
In Commercial Distribution

  • 10810170018135 ()
  • 00810170018138 ()

  • 4 mm x 4 cm
45-080404

  • Adenovirus immunoglobulin A (IgA) antibody IVD, calibrator
Azur
MICROVENTION INC.
45-080402
In Commercial Distribution

  • 10810170018128 ()
  • 00810170018121 ()

  • 4 mm x 2 cm
45-080402

  • Adenovirus immunoglobulin A (IgA) antibody IVD, calibrator
Azur
MICROVENTION INC.
45-080306
In Commercial Distribution

  • 10810170018111 ()
  • 00810170018114 ()

  • 3 mm x 6 cm
45-080306

  • Adenovirus immunoglobulin A (IgA) antibody IVD, calibrator
Azur
MICROVENTION INC.
45-080304
In Commercial Distribution

  • 10810170018104 ()
  • 00810170018107 ()

  • 3 mm x 4 cm
45-080304

  • Adenovirus immunoglobulin A (IgA) antibody IVD, calibrator
Azur
MICROVENTION INC.
45-080302
In Commercial Distribution

  • 10810170018098 ()
  • 00810170018091 ()

  • 3 mm x 2 cm
45-080302

  • Adenovirus immunoglobulin A (IgA) antibody IVD, calibrator
Rabbit Monoclonal Anti-Human IgA (170), concentrated
Epitomics Inc.
AC-0147BULK
In Commercial Distribution

  • 00810113063867 ()


  • Total immunoglobulin A (IgA total) IVD, antibody
Rabbit Monoclonal Anti-Human IgA (170), 1 mL concentrated
Epitomics Inc.
AC-0147
In Commercial Distribution

  • 00810113063843 ()

  • Total Volume: 1 Milliliter


  • Total immunoglobulin A (IgA total) IVD, antibody
Rabbit Monoclonal Anti-Human IgA (170), 0.5 mL concentrated
Epitomics Inc.
AC-0147B
In Commercial Distribution

  • 00810113063836 ()

  • Total Volume: 0.5 Milliliter


  • Total immunoglobulin A (IgA total) IVD, antibody
No Description
KENT LABORATORIES INC
1
In Commercial Distribution

  • B1761028 ()
102872

  • Total immunoglobulin A (IgA total) IVD, antibody
Radial immunodiffusion plate package for human IgA with three standards
KENT LABORATORIES INC
1
In Commercial Distribution

  • B1761025 ()
102511

  • Total immunoglobulin A (IgA total) IVD, antibody
Radial immunodiffusion plate package for human IgA
KENT LABORATORIES INC
1
In Commercial Distribution

  • B1761024 ()
102411

  • Total immunoglobulin A (IgA total) IVD, antibody
Fluorescein conjugated polyclonal goat antiserum to Human IgA
KENT LABORATORIES INC
1
In Commercial Distribution

  • B1761022 ()
102202

  • Total immunoglobulin A (IgA total) IVD, antibody
No Description
KENT LABORATORIES INC
1
In Commercial Distribution

  • B1761021 ()
1021002

  • Total immunoglobulin A (IgA total) IVD, antibody
Goat antiserum to Human IgA
KENT LABORATORIES INC
1
In Commercial Distribution

  • B1761020 ()
102002

  • Total immunoglobulin A (IgA total) IVD, antibody
Moxi B3-RS Right (sand)
Sonova AG
050-6473-R8
In Commercial Distribution

  • 07613389528084 ()


  • Immunoglobulin A subclass (IgA subclass) IVD, control
Moxi B5-RS Left (platinum)
Sonova AG
050-6474-P6
In Commercial Distribution

  • 07613389527353 ()


  • Immunoglobulin A subclass (IgA subclass) IVD, control
Phonak Slim L50-R Left (cooper/black)
Sonova AG
050-1009-4A
In Commercial Distribution

  • 07613389480443 ()


  • Immunoglobulin A subclass (IgA subclass) IVD, control
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
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)
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)
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
Stockert GmbH
M490025
In Commercial Distribution

  • 04260166371499 ()


  • Electrical catheter connection cable, reusable
No Description
MASIMO CORPORATION
1778
In Commercial Distribution

  • 00843997000505 ()


  • Pulse oximeter probe, reusable
No Description
MASIMO CORPORATION
1851
In Commercial Distribution

  • 10843997010358 ()


  • Pulse oximeter probe, single-use
No Description
MASIMO CORPORATION
1776
In Commercial Distribution

  • 10843997000496 ()
  • 00843997000499 ()


  • Pulse oximeter probe, single-use
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
iotaSOFT Rolling Stand
Iotamotion, Inc.
IM-04
In Commercial Distribution

  • 00850002960044 ()


  • Robotic surgical system application software
iotaSOFT Footpedal
Iotamotion, Inc.
IM-03
In Commercial Distribution

  • 00850002960037 ()


  • Robotic surgical system application software
iotaSOFT Console
Iotamotion, Inc.
IM-02
In Commercial Distribution

  • 00850002960020 ()


  • Robotic surgical system application software
iotaSOFT Drive Unit
Iotamotion, Inc.
IM-00
In Commercial Distribution

  • 00850002960006 ()


  • Robotic surgical system application software
Xpect Flu A&B KT/20TST
REMEL, INC.
R24600
In Commercial Distribution

  • 30848838027032 ()
  • 00848838027031 ()


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