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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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No Description
Diasorin Inc.
310830
In Commercial Distribution

  • 08056771600231 ()
  • 18056771600238 ()


  • Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
No Description
DIASORIN SPA
310705
In Commercial Distribution

  • 08056771100762 ()


  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
(S. cerevisiae) 1. 1x ASCA IgG ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted ASCA IgG ELISA Low Positive 4. 1x 1.2mL prediluted ASCA IgG ELISA High Positive 5. 1x 50mL HRP Sample Diluent 6. 1x 25mL HRP Wash Concentrate, 40x concentrate 7. 1x 10mL HRP IgG Conjugate, (goat), anti-human IgG 8. 1x 10mL TMB Chromogen 9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid
INOVA DIAGNOSTICS, INC.
708865
In Commercial Distribution

  • 08426950514206 ()


  • Saccharomyces cerevisiae immunoglobulin G (IgG) antibody IVD, kit enzyme immunoassay (EIA)
Coolief* Cooled Radiofrequency Introducer
Avanos Medical, Inc.
44208
In Commercial Distribution

  • 10680651442083 ()
CRI-17-100-4

  • Ross River virus (RRV) immunoglobulin G (IgG) antibody IVD, calibrator
Coolief* Cooled Radiofrequency Introducer
Avanos Medical, Inc.
44207
In Commercial Distribution

  • 10680651442076 ()
CRI-17-75-5.5

  • Ross River virus (RRV) immunoglobulin G (IgG) antibody IVD, calibrator
The Aspergillus fumigatus ELISA test is a qualitative enzyme immunoassay for the detection of Aspergillus fumigatus antibodies in human serum samples.
Bordier affinity products S.A.
6100
In Commercial Distribution

  • 07640158216101 ()
6100

  • Aspergillus fumigatus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
ACCURUN 115 Hepatitis B Core IgG 1 x 5.0 mL
Lgc Clinical Diagnostics, Inc.
2015-0070
In Commercial Distribution

  • 00816784020284 ()
2015-0070

  • Hepatitis B virus core immunoglobulin G (IgG) antibody IVD, control
"720-310 Toxoplasma IgM Test Kit"
DIAMEDIX CORPORATION
720-310
In Commercial Distribution

  • 00817273020143 ()


  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
"720-300 Toxoplasma IgG Test Kit"
DIAMEDIX CORPORATION
720-300
In Commercial Distribution

  • 00817273020136 ()


  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
No Description
Bion Enterprises, Ltd.
HS2G-120
In Commercial Distribution

  • B110HS2G1200 ()
HS2G-120

  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
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