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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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Detection of Anti-Streptolysin-O
ARLINGTON SCIENTIFIC, INC.
NC-300050
In Commercial Distribution

  • 00816057020140 ()

  • 50 Test
NC-300050

  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, reagent
Detection of Anti-Strptolysin-O, Export
ARLINGTON SCIENTIFIC, INC.
NC-300025E
In Commercial Distribution

  • 00816057020133 ()

  • 25 Test
NC-300025E

  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, reagent
Detection of Anti-Streptolysin O
ARLINGTON SCIENTIFIC, INC.
NC-300025
In Commercial Distribution

  • 00816057020126 ()

  • 25 Test
NC-300025

  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, reagent
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
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
No Description
Response Biomedical Corp
C1107
Not in Commercial Distribution

  • 10627966005176 ()


  • Influenza A/B virus antigen IVD, kit, fluorescent immunoassay
No Description
Roche Diagnostics GmbH
08086672190
In Commercial Distribution

  • 07613336129746 ()
08086672190

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