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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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No Description
CELL MARQUE CORPORATION
260M-15
In Commercial Distribution

  • 00841683131281 ()


  • CD235a glycophorin A red blood cell marker IVD, antibody
No Description
CELL MARQUE CORPORATION
260M-14
In Commercial Distribution

  • 00841683131274 ()


  • CD235a glycophorin A red blood cell marker IVD, antibody
No Description
CELL MARQUE CORPORATION
760-4257
In Commercial Distribution

  • 00841683100522 ()


  • CD235a glycophorin A red blood cell marker IVD, antibody
For the calibration of the K-ASSAY® ASO (WHO) assay.
KAMIYA BIOMEDICAL COMPANY, LLC
KAI-079C
In Commercial Distribution

  • 00816426020627 ()
KAI-079C

  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, calibrator
For the quantitative determination of human streptolysin O (ASO) in serum by immunoturbidimetric assay.
KAMIYA BIOMEDICAL COMPANY, LLC
KAI-078
In Commercial Distribution

  • 00816426020337 ()
KAI-078

  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, reagent
No Description
MONOBIND, INC.
HPC-300
In Commercial Distribution

  • 00816870020211 ()

  • Width: 2 Inch
HPC-300

  • Helicobacter pylori immunoglobulin A (IgA)/IgG antibody IVD, control
ACCURUN 121 HAV IgM 6 x 3.5 mL
Lgc Clinical Diagnostics, Inc.
2015-0076
In Commercial Distribution

  • 00816784020338 ()


  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, control
ACCURUN 121 HAV IgM 1 x 5.0 mL
Lgc Clinical Diagnostics, Inc.
2015-0074
In Commercial Distribution

  • 00816784020321 ()
2015-0074

  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, control
2 x 2.5 ml REAGENT 1 x 1.5 ml CONTROL + 1 x 1.5 ml CONTROL – 2 x 9 SLIDES
BIOKIT, S.A.
3000-7010
In Commercial Distribution

  • 08426950457305 ()


  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, calibrator
VITROS Immunodiagnostic Products Anti-HAV IgM Controls
ORTHO CLINICAL DIAGNOSTICS
6800835
In Commercial Distribution

  • 10758750000883 ()
  • 20758750000880 ()
6800835

  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, control
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