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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
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
No Description
DIESSE DIAGNOSTICA SENESE SPA
81036
In Commercial Distribution

  • 08033891327668 ()
81036

  • Respiratory syncytial virus (RSV) 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
Penicillin 10μg (P10) HardyDisk™ AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Haemophilus spp., Neisseria gonorrhoeae, N. meningitidis and Streptococcus spp., including Streptococcus pneumoniae.
HARDY DIAGNOSTICS
Z8885
In Commercial Distribution

  • 00816576020898 ()
  • 00816576021710 ()
Z8885

  • Penicillin G susceptibility testing disc IVD
Penicillin 10μg (P10) HardyDisk™ AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Haemophilus spp., Neisseria gonorrhoeae, N. meningitidis and Streptococcus spp., including Streptococcus pneumoniae.
HARDY DIAGNOSTICS
Z8881
In Commercial Distribution

  • 00816576020881 ()
  • 00816576021710 ()
Z8881

  • Penicillin G susceptibility testing disc IVD
"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
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)
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