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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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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
VITROS Immunodiagnostic Products Anti-HAV Total Controls
ORTHO CLINICAL DIAGNOSTICS
6801463
In Commercial Distribution

  • 10758750001293 ()
6801463

  • Hepatitis A virus total antibody 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
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 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)
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