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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
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
"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
Detection of Rubella Virus Antibodies
ARLINGTON SCIENTIFIC, INC.
NC-605001
In Commercial Distribution

  • 00816057021635 ()

  • Total Volume: 1 Milliliter
NC-605001

  • Rubella virus immunoglobulin G (IgG)/IgM antibody IVD, control
No Description
SCIMEDX CORPORATION
I-HV201X
In Commercial Distribution

  • 00813545025731 ()
I-HV201X

  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
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-HV101X
In Commercial Distribution

  • 00813545025700 ()
I-HV101X

  • Herpes simplex virus 1 (HSV1) 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
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
For the detection and titration of HSV-1 IgG antibodies in human sera
Hemagen Diagnostics, Inc.
902501
In Commercial Distribution

  • G5229025011 ()


  • Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
For the detection and titration of HSV-1 IgG antibodies in human sera
Hemagen Diagnostics, Inc.
902500
In Commercial Distribution

  • G5229025001 ()


  • Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
For the detection and titration of Toxoplasma gondii IgG antibodies
Hemagen Diagnostics, Inc.
902021
In Commercial Distribution

  • G5229020211 ()


  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
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
For the detection and titration of Toxoplasma gondii IgG antibodies
Hemagen Diagnostics, Inc.
902010
In Commercial Distribution

  • G5229020101 ()


  • 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 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 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)
The ZEUS ELISA Herpes Simplex Virus-2 (HSV-2) IgG Test System is an enzyme-linked immunosorbent assays (ELISA) for the qualitative detection of IgG class antibodies to Herpes Simplex Virus (HSV) in human serum. The test is intended to be used to evaluate serologic evidence of primary or reactivated infection with HSV. Due to cross-reactivity of shared antigens, both tests (HSV-1 and HSV-2 ELISAs) must be run in parallel on the same sample to fully evaluate patient sera. This test is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
SM9Z9751G
In Commercial Distribution

  • 00845533000758 ()
SM9Z9751G

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