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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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For the detection and titration of Toxoplasma gondii IgG antibodies
Hemagen Diagnostics, Inc.
902020
In Commercial Distribution

  • G5229020201 ()


  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
The Access Toxo IgG assay is a paramagnetic particle, chemiluminescent immunoassay for the qualitative and quantitative determination of IgG antibodies to Toxoplasma gondii in human serum using the Access Immunoassay Systems.
Beckman Coulter, Inc.
A31588
In Commercial Distribution

  • 15099590624927 ()
A31588

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
The Access Toxo IgG QC is intended for monitoring system performance of the Access Toxo IgG assay.
Beckman Coulter, Inc.
A31590
In Commercial Distribution

  • 15099590624903 ()
A31590

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
The Access Toxo IgG Calibrators are intended to calibrate the Access Toxo IgG assay for the qualitative and quantitative determination of IgG antibodies to Toxoplasma gondii in human serum using the Access Immunoassay Systems.
Beckman Coulter, Inc.
A31589
In Commercial Distribution

  • 15099590624910 ()
A31589

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
The Respiratory Syncytial Virus IgG ELISA is intended for the qualitative determination of IgG class antibodies against respiratory syncytial virus in human serum or plasma (citrate, heparin).
Gold Standard Diagnostics Frankfurt GmbH
RSVG0380
In Commercial Distribution

  • ENTIRSVG03800 ()
RSVG0380

  • Respiratory syncytial virus (RSV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
THE BINDING SITE GROUP LIMITED
MA004
In Commercial Distribution

  • 05051700020312 ()


  • Total immunoglobulin G (IgG total) IVD, reagent
AccuDiag ™Herpes Simplex 2 IgG (HSV 2 IgG) ELISA
Diagnostic Automation, Inc.
DACD1403-2
In Commercial Distribution

  • 00850054026088 ()

  • 96 Tests
1403-2

  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Lyme Disease Positive Control is intended for use with in vitro assays, for determination of IgG antibodies to Borrelia burgdorferi and IgM antibodies to Borrelia burgdorferi. Lyme Disease Positive Control is unassayed without target values and is suitable for use on many analysers.
RANDOX LABORATORIES LIMITED
SR10346
In Commercial Distribution

  • 05055273216394 ()
SR10346

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, control
Lyme Disease Negative Control is intended for use as an unassayed non-reactive quality assurance reagent, with in vitro assays detecting IgG antibodies to Borrelia burgdorferi and IgM antibodies to Borrelia burgdorferi.
RANDOX LABORATORIES LIMITED
SR10345
In Commercial Distribution

  • 05055273216387 ()
SR10345

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, control
These IgG Sensitized Red Blood Cells are for the control of the Indirect Antiglobulin Test (IAT) and Direct Antiglobulin Test (DAT).
ALBA BIOSCIENCE LIMITED
Z443U
In Commercial Distribution

  • 05060242472336 ()
  • 05060242472329 ()
  • 05060242472343 ()
  • 05060242472350 ()


  • Immunoglobulin-sensitized reagent red blood cell IVD, control
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