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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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TEST KIT, H PYLORI (25/KT)
MCKESSON MEDICAL-SURGICAL INC.
5008
In Commercial Distribution

  • 00612479240070 ()
  • 00612479202702 ()


  • Helicobacter pylori IgG antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test
The ZEUS AtheNA Multi-Lyte® ToRCH IgG Plus Test System is intended for the qualitative detection of specific human IgG class antibodies to Toxoplasma gondii (T.gondii), Rubella, Cytomegalovirus (CMV), HSV-1 and HSV-2 in human serum. The results of this assay are intended to be used as an aid in the assessment of serological status to Toxoplasma gondii, Rubella and CMV. For HSV-1 and HSV-2, the test is indicated for sexually active adults and expectant mothers, as an aid for presumptively diagnosing Herpes Simplex 1 and Herpes Simplex 2. The test is not intended for use in screening blood or plasma donors. The performance of this assay has not been established for use in a pediatric population, neonatal screening, immunocompromised or immunosuppressed patients or for use at point of care facilities. This test is for In Vitro diagnostic use only.
ZEUS SCIENTIFIC, INC.
A81101G
In Commercial Distribution

  • 00845533000093 ()
A81101G

  • Multiple infectious organism/newborn TORCH screen IVD, kit, fluorescent immunoassay
No Description
Lgc Clinical Diagnostics, Inc.
2000-0102
In Commercial Distribution

  • 00850041090030 ()


  • Multiple infectious organism/newborn TORCH screen IVD, control
No Description
Lgc Clinical Diagnostics, Inc.
2015-0240
In Commercial Distribution

  • 00850041090023 ()


  • Multiple infectious organism/newborn TORCH screen IVD, control
No Description
Lgc Clinical Diagnostics, Inc.
2010-0023
In Commercial Distribution

  • 00850041090016 ()


  • Multiple infectious organism/newborn TORCH screen IVD, control
No Description
Lgc Clinical Diagnostics, Inc.
2000-0101
In Commercial Distribution

  • 00850041090009 ()


  • Multiple infectious organism/newborn TORCH screen IVD, control
EIA Color Developer, 13.0 mL
MARDX DIAGNOSTICS, INC.
40-1006
In Commercial Distribution

  • 05391516747714 ()
40-1006

  • Helicobacter pylori immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
  • Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Nebulizer Adaptor 22mm O.D. x 18mm O.D.
TELEFLEX INCORPORATED
IPN029720
In Commercial Distribution

  • 24026704658798 ()
  • 14026704658791 ()
  • 04026704595525 ()
1746

  • Cardiac sizing catheter
In-Line NebTee with Valve 22mm O.D. x 18mm I.D. x 22mm O.D.
TELEFLEX INCORPORATED
IPN029719
In Commercial Distribution

  • 24026704658781 ()
  • 14026704658784 ()
  • 04026704595518 ()
1744

  • Cardiac sizing catheter
In-Line NebTee with Valve 22mm O.D. x 18mm I.D. x 22mm I.D.
TELEFLEX INCORPORATED
IPN029718
In Commercial Distribution

  • 24026704658774 ()
  • 14026704658777 ()
  • 04026704595501 ()
1743

  • Cardiac sizing catheter
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