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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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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
No Description
SCIMEDX CORPORATION
I-HV201G
In Commercial Distribution

  • 00813545025717 ()
I-HV201G

  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
No Description
SCIMEDX CORPORATION
I-HV101G
In Commercial Distribution

  • 00813545025687 ()
I-HV101G

  • Herpes simplex virus 1 (HSV1) 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
No Description
Bion Enterprises, Ltd.
HS1G-120
In Commercial Distribution

  • B110HS1G1200 ()
HS1G-120

  • Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, kit, fluorescent 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 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 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)
IgG-coated red blood cells used to confirm negative results in direct antiglobulin test (DAT) and indirect antiglobulin test (IAT).
AMERICAN NATIONAL RED CROSS
510400/510402
In Commercial Distribution

  • 20858400005095 ()
  • 00858400005091 ()
  • 10858400005098 ()


  • Immunoglobulin-sensitized reagent red blood cell IVD, control
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