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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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Tubigrip G Natural x 10m
Mölnlycke Health Care AB
1439
In Commercial Distribution

  • 07332551449544 ()
  • 07332551449551 ()
  • 07332551947996 ()

  • G


  • Tubular support bandage, Hevea-latex
G&G ANGLED WEDGE BUNDLE BARIATRIC 14
Asp Global, LLC
GGTS14
In Commercial Distribution

  • 00840216121898 ()


  • Freestanding patient positioner, reusable
G&G ROUNDED WEDGE 44X60 BUNDLE 12
Asp Global, LLC
GGTS12
In Commercial Distribution

  • 00840216120501 ()


  • Freestanding patient positioner, reusable
BAILEY LACHRYMAL CANNULA G w g reinforce
Avalign Technologies, Inc.
92-850
In Commercial Distribution

  • 00190776201395 ()


  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
VIROTROL EBV (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
00128B
In Commercial Distribution

  • 00847661005575 ()
00128B

  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin M (IgM) antibody IVD, control
  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, control
VIROTROL EBV (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
00128A
In Commercial Distribution

  • 00847661005568 ()
00128A

  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin M (IgM) antibody IVD, control
  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, control
VIROCLEAR EBV (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
00131
In Commercial Distribution

  • 00847661002727 ()
00131

  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin M (IgM) antibody IVD, control
  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, control
An in vitro diagnostic test for the detection of anti-Dengue IgM and/or IgG in human whole blood of dengue infected patient from acute to convalescent stage.
NANO-DITECH CORPORATION
MD8144
In Commercial Distribution

  • 00895160002489 ()
  • 10895160002486 ()
MD8144

  • Dengue virus immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, rapid ICT, clinical
An in vitro diagnostic test for the detection of Dengue NS1 protein in human whole blood of dengue infected patient from acute to convalescent stage.
NANO-DITECH CORPORATION
MD8143
Not in Commercial Distribution

  • 00895160002472 ()
  • 10895160002479 ()
MD8143

  • Dengue virus immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, rapid ICT, clinical
Teco Diagnostics Anti-Streptolysin O (ASO) Reagent Set is for the qualitative and semi-quantitative measurement of antibodies to streptococcal exoenzymes in human serum.
TECO DIAGNOSTICS
ASO-100
In Commercial Distribution

  • 10673486002447 ()
ASO-100

  • Beta-haemolytic multiple group Streptococcus streptolysin O antibody IVD, kit, rapid agglutination, clinical
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