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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 - 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

VIROTROL - 03610522207862

VIROTROL SARS-CoV-2 (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
200300C
In Commercial Distribution

  • 03610522207862 ()
200300C

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

VIROTROL - 03610522207855

VIROTROL SARS-CoV-2 (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
200300B
In Commercial Distribution

  • 03610522207855 ()
200300B

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

VIROTROL - 03610522207848

VIROTROL SARS-CoV-2 (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
200300A
In Commercial Distribution

  • 03610522207848 ()
200300A

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

VIROTROL - 03610520540718

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

Signify® - 10815845020079

No Description
ALERE SAN DIEGO, INC.
01P53-25
Not in Commercial Distribution

  • 10815845020079 ()
  • 00815845020072 ()


  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, rapid ICT, clinical

Clearview® - 10815845020048

No Description
ALERE SAN DIEGO, INC.
92405
Not in Commercial Distribution

  • 10815845020048 ()
  • 00815845020041 ()


  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, rapid ICT, clinical

PTS-X™ - 04046955677405

PTSX409 PTS-X BALLOON 40MM X 5CM X 110CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613725
In Commercial Distribution

  • 04046955677405 ()
613725

  • Cardiac sizing catheter

PTS-X™ - 04046955677382

PTSX407 PTS-X BALLOON 40MM X 3CM X 110CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613724
In Commercial Distribution

  • 04046955677382 ()
613724

  • Cardiac sizing catheter
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