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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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B&G PERIOSTEAL ELEVATOR DOUBLE END G/FOX HND700
NORDENT MANUFACTURING INC
EPGF14/BG
In Commercial Distribution

  • 00840018649101 ()


  • Periosteal elevator, reusable
FITC Mounting Medium (pH 7.5), 3.0 mL
MARDX DIAGNOSTICS, INC.
90-1610
In Commercial Distribution

  • 05391516747943 ()
90-1610

  • Borrelia burgdorferi total antibody IVD, kit, immunoblot
  • Glomerular basement membrane antibody (Goodpasture antibody) IVD, kit, fluorescent immunoassay
  • Skeletal muscle antibody IVD, kit, fluorescent immunoassay
  • Trypanosoma cruzi immunoglobulin G (IgG)/IgM antibody IVD, kit, fluorescent immunoassay
  • Multiple Leishmania species immunoglobulin G (IgG)/IgM antibody IVD, kit, fluorescent immunoassay
Scale, Digital
SAKURA FINETEK U.S.A., INC.
0204
In Commercial Distribution

  • 00615233012753 ()
0204

  • Laboratory scale, electronic
Scale, Economy Grade
SAKURA FINETEK U.S.A., INC.
0203
In Commercial Distribution

  • 00615233012746 ()
0203

  • Laboratory scale, mechanical
ToRCH IgM Positive Control is intended for use with in vitro assays for determination of IgM antibodies to Cytomegalovirus (CMV), IgM antibodies to Rubella Virus, IgM antibodies to Toxoplasma gondii, IgM antibodies to Herpes Simplex Virus Type 1 and 2. ToRCH IgM Positive Control is unassayed without target values and is suitable for use on many analysers. This control must not be used as a substitute for the mandatory manufacturer’s kit controls provided with the assay. ToRCH IgM Positive Control is helpful in determining the precision of testing systems and in identifying sources of variation.
RANDOX LABORATORIES LIMITED
SR10349
In Commercial Distribution

  • 05055273216424 ()
SR10349

  • Multiple infectious organism/newborn TORCH screen IVD, control
ToRCH Negative Control is intended for use as an unassayed non-reactive quality assurance reagent with in vitro assays detecting IgG and IgM antibodies to Cytomegalovirus (CMV), IgG and IgM antibodies to Rubella virus, IgG and IgM antibodies to Toxoplasma gondii, IgG and IgM antibodies to Herpes Simplex Type 1 and 2, IgG antibodies to Mumps Virus, IgG antibodies to Rubeola Virus (Measles), IgG antibodies to Varicella Zoster Virus, IgG antibodies to Helicobacter pylori, IgG antibodies to Treponema pallidum (Syphilis), IgG and IgM antibodies to the Viral Capsid Antigen of Epstein-Barr virus (EBV VCA) and IgG antibodies to the Viral Polypeptide Nuclear Antigen of Epstein-Barr Virus (EBV EBNA IgG).
RANDOX LABORATORIES LIMITED
SR10347
In Commercial Distribution

  • 05055273216400 ()
SR10347

  • Multiple infectious organism/newborn TORCH screen IVD, control
The Universal Cannula is designed to provide a port of entry into the abdominal cavity during laparoscopic & endoscopic procedures.
PURPLE SURGICAL INTERNATIONAL LIMITED
PS3506
In Commercial Distribution

  • 50551223003989 ()
  • 35051223003985 ()
  • 05051223003984 ()

  • 12mm diameter x 100mm length
PS3506

  • Cardiac sizing catheter
ToRCH EBV Positive Control is intended for use with in vitro assays for determination of IgG and IgM antibodies to the viral capsid antigen of Epstein-Barr Virus (EBV VCA) and IgG antibodies to the viral polypeptide nuclear antigen of Epstein-Barr Virus (EBV EBNA). ToRCH EBV Positive Control is unassayed without target values and is suitable for use on many analysers. This control must not be used as a substitute for the mandatory manufacturer’s kit controls provided with the assay. ToRCH EBV Positive Control is helpful in determining the precision of testing systems and in identifying sources of variation.
RANDOX LABORATORIES LIMITED
SR10350
In Commercial Distribution

  • 05055273216431 ()
SR10350

  • Multiple infectious organism/newborn TORCH screen IVD, control
ToRCH IgG Positive Control is intended for use with in vitro assays for determination of IgG antibodies to Cytomegalovirus (CMV), IgG antibodies to Rubella Virus, IgG antibodies to Toxoplasma gondii, IgG antibodies to Herpes Simplex Virus Type 1 and 2, IgG antibodies to Mumps Virus, IgG antibodies to Measles Virus, IgG antibodies to Varicella Zoster Virus, IgG antibodies to Helicobacter pylori IgG antibodies to Treponema pallidum (Syphilis), IgG antibodies to the viral polypeptide nuclear antigen of Epstein-Barr Virus (EBV EBNA). ToRCH IgG Positive Control is unassayed without target values and is suitable for use on many analysers. This control must not be used as a substitute for the mandatory manufacturer’s kit controls provided with the assay. ToRCH IgG Positive Control is helpful in determining the precision of testing systems and in identifying sources of variation.
RANDOX LABORATORIES LIMITED
SR10348
In Commercial Distribution

  • 05055273216417 ()
SR10348

  • Multiple infectious organism/newborn TORCH screen IVD, control
TEST KIT, H PYLORI (10/KT)
MCKESSON MEDICAL-SURGICAL INC.
5007
In Commercial Distribution

  • 00612479240087 ()
  • 00612479202719 ()


  • Helicobacter pylori IgG antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test
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