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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
MONOBIND, INC.
HPC-300
In Commercial Distribution

  • 00816870020211 ()

  • Width: 2 Inch
HPC-300

  • Helicobacter pylori immunoglobulin A (IgA)/IgG 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
VITROS Chemistry Products Calibrator Kit 28
ORTHO-CLINICAL DIAGNOSTICS, INC.
6802323
In Commercial Distribution

  • 10758750002597 ()
6802323

  • 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
No Description
Ventana Medical Systems, Inc.
05267927001
In Commercial Distribution

  • 04015630971503 ()
05267927001

  • Human immunoglobulin A (IgA) animal conjugate antibody reagent IVD
Immunoglobulin A Reagent (Ig-A 2 x 150)
Beckman Coulter, Inc.
467920
In Commercial Distribution

  • 15099590231620 ()
467920

  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry
L-DFA Influenza A/Influenza B Reagent
DIAGNOSTIC HYBRIDS, INC.
01-123104
In Commercial Distribution

  • 30014613330851 ()
01-123104

  • Influenza A/B virus antigen IVD, kit, fluorescent immunoassay
Sofia Strep A+ 25T
QUIDEL CORPORATION
20276
In Commercial Distribution

  • 30014613202769 ()
20276

  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, fluorescent immunoassay
Sofia Strep A+ 25T, US
QUIDEL CORPORATION
20274
In Commercial Distribution

  • 30014613202745 ()
20274

  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, fluorescent immunoassay
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