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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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VIROTROL ToRCH-M (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
00117A
In Commercial Distribution

  • 03610520540718 ()
00117A

  • Multiple infectious organism/newborn TORCH screen IVD, control
Teco Diagnostics H. pylori Card Test is an immunochromatographic assay for the qualitative determination of IgG antibodies specific to Helicobacter pylori (H. pylori) in human serum. The test is intended for professional use as an aid in the diagnosis of H. pylori infections.
TECO DIAGNOSTICS
H730-A
In Commercial Distribution

  • 10673486002393 ()
H730-A

  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, rapid ICT, clinical
ACCURUN 26 ToRC IgM Series 5000 3 x 1.0 mL
Lgc Clinical Diagnostics, Inc.
2000-0035
In Commercial Distribution

  • 00816784020147 ()
2000-0035

  • Multiple infectious organism/newborn TORCH screen IVD, control
ACCURUN 25 ToRCH IgG Series 5000 3 x 1.0 mL
Lgc Clinical Diagnostics, Inc.
2000-0034
In Commercial Distribution

  • 00816784020130 ()
2000-0034

  • Multiple infectious organism/newborn TORCH screen IVD, control
"300-371A Rubella IgM Capture Lyoph. Ag. Accessory Kit"
DIAMEDIX CORPORATION
300-371A
In Commercial Distribution

  • 00817273020044 ()


  • Multiple infectious organism/newborn TORCH screen IVD, kit, enzyme immunoassay (EIA)
No Description
Bion Enterprises, Ltd.
VZ-7012
In Commercial Distribution

  • B110VZ70120 ()
VZ-7012

  • Varicella-zoster virus (VZV) immunoglobulin M (IgM) antibody IVD, reagent
  • Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, reagent
No Description
Bion Enterprises, Ltd.
EB-5012
In Commercial Distribution

  • B110EB50120 ()
EB-5012

  • Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, reagent
  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, reagent
Sizing Balloon II
ST. JUDE MEDICAL, INC.
9-SB-024
In Commercial Distribution

  • 00811806011523 ()

  • Outer Diameter: 24.0000 Millimeter
  • Length: 70.0000 Centimeter
9-SB-024

  • Cardiac sizing catheter
Sizing Balloon II
ST. JUDE MEDICAL, INC.
9-SB-018
In Commercial Distribution

  • 00811806011516 ()

  • Length: 70.0000 Centimeter
  • Outer Diameter: 18.0000 Millimeter
9-SB-018

  • Cardiac sizing catheter
No Description
Bion Enterprises, Ltd.
MP-1212
In Commercial Distribution

  • B110MP12120 ()
MP-1212

  • Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD, reagent
  • Mycoplasma pneumoniae immunoglobulin G (IgG) antibody IVD, reagent
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