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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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PTS® - 04046964311017

PTS403 PTS BALLOON 40MM X 3CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613705
In Commercial Distribution

  • 04046964311017 ()
613705

  • Cardiac sizing catheter

PTS® - 04046964310973

PTS304 PTS BALLOON 30MM X 4CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613703
In Commercial Distribution

  • 04046964310973 ()
613703

  • Cardiac sizing catheter

PTS® - 04046964310935

PTS253 PTS BALLOON 25MM X 3CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613701
In Commercial Distribution

  • 04046964310935 ()
613701

  • Cardiac sizing catheter

PTS® - 04046964310911

PTS203 PTS BALLOON 20MM X 3CM X 80CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613700
In Commercial Distribution

  • 04046964310911 ()
613700

  • Cardiac sizing catheter

Teco Diagnostics H. pylori Card Test - 10673486002393

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

VIROCLEAR - 03610522207930

VIROCLEAR SARS-CoV-2 (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
200505
In Commercial Distribution

  • 03610522207930 ()
200505

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control
  • SARS-CoV-2 total antibody IVD, control

VIROCLEAR - 03610522207923

VIROCLEAR SARS-CoV-2 (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
200500
In Commercial Distribution

  • 03610522207923 ()
200500

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control
  • SARS-CoV-2 total antibody IVD, control

VIROTROL - 03610522207893

VIROTROL SARS-CoV-2 (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
200305C
In Commercial Distribution

  • 03610522207893 ()
200305C

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control
  • SARS-CoV-2 total antibody IVD, control

VIROTROL - 03610522207886

VIROTROL SARS-CoV-2 (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
200305B
In Commercial Distribution

  • 03610522207886 ()
200305B

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control
  • SARS-CoV-2 total antibody IVD, control

VIROTROL - 03610522207879

VIROTROL SARS-CoV-2 (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
200305A
In Commercial Distribution

  • 03610522207879 ()
200305A

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control
  • SARS-CoV-2 total antibody IVD, control
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