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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GENORAY CO., LTD.
SUNI Pan Q
In Commercial Distribution

  • 08809244061165 ()


  • Stationary panoramic dental x-ray system, digital
Rabbit antiserum, Ready to use
Ssi Diagnostica A/S
16740
In Commercial Distribution

  • 05713106167403 ()
16740

  • Streptococcus pneumoniae culture isolate antigen IVD, antibody
A comprehensive range of Salmonella slide agglutination antisera in 3.0 ml dropper bottles with shelf lives up to five years from date of manufacture. The range includes a full panel of polyvalent somatic antisera, monovalent somatic antisera, polyvalent flagella antisera and monovalent flagella antisera for traditional slide agglutination testing. Also available are a range of rapid Salmonella diagnostic sera (RSD) for the initial identification of primary groups of Salmonella. All antisera are presented in colour coded dropper bottles.
PRO-LAB, INCORPORATED
PL.6131
In Commercial Distribution

  • 05060472462473 ()
PL.6131

  • Multiple Salmonella species antigen IVD, kit, rapid agglutination, clinical
Warmed Gutta Percha Obturation System
Meta Biomed Co., Ltd.
9039
Not in Commercial Distribution

  • 08806387890393 ()


  • Endodontic obturation system
Warmed Gutta Percha Obturation System
Meta Biomed Co., Ltd.
9038
Not in Commercial Distribution

  • 08806387890386 ()


  • Endodontic obturation system
Warmed Gutta Percha Obturation System
Meta Biomed Co., Ltd.
9037
Not in Commercial Distribution

  • 08806387890379 ()


  • Endodontic obturation system
Warmed Gutta Percha Obturation System
Meta Biomed Co., Ltd.
9036
Not in Commercial Distribution

  • 08806387890362 ()


  • Endodontic obturation system
Warmed Gutta Percha Obturation System
Meta Biomed Co., Ltd.
9035
Not in Commercial Distribution

  • 08806387890355 ()


  • Endodontic obturation system
The ZEUS ELISA Measles IgG Test System is designed for the qualitative detection of IgG antibodies to Measles (Rubeola) virus in human serum, and is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
Q9Z9271GB
In Commercial Distribution

  • 00845533000826 ()
Q9Z9271GB

  • Measles virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The ZEUS ELISA Epstein Barr Virus Early Antigen (EBV-EA) IgG Test System provides a means for the qualitative detection of IgG class antibodies to Epstein-Barr Virus (EBV) Early Antigen (EA) in human sera. This test is intended to aid in the diagnosis of infectious mononucleosis (IM) when used with other EBV serological tests. The performance characteristics have not been established to aid in the diagnosis of acute IM. This test is intended for In Vitro diagnostic use only.
ZEUS SCIENTIFIC, INC.
Q9Z9481G
In Commercial Distribution

  • 00845533000536 ()
Q9Z9481G

  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
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