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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
DIASORIN SPA
310211
In Commercial Distribution

  • 08056771100229 ()


  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, control
No Description
DIASORIN SPA
310200
In Commercial Distribution

  • 08056771100199 ()


  • Hepatitis A virus total antibody IVD, kit, chemiluminescent immunoassay
1 QUANTA Flash HMGCR Reagent Cartridge. 1 Resuspension Buffer. 1 Transfer pipette.
INOVA DIAGNOSTICS, INC.
701333
In Commercial Distribution

  • 08426950793182 ()


  • 3-Hydroxy-3-methylglutaryl-coenzyme A reductase (HMGCR) antibody IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
08086672190
In Commercial Distribution

  • 07613336129746 ()
08086672190

  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, control
No Description
Roche Diagnostics GmbH
08057885190
In Commercial Distribution

  • 07613336121313 ()
08057885190

  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry
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
Sofia Strep A 25T, US
QUIDEL CORPORATION
20253
In Commercial Distribution

  • 30014613202530 ()
20253

  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, fluorescent immunoassay
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
No Description
MONOBIND, INC.
HPC-300
In Commercial Distribution

  • 00816870020211 ()

  • Width: 2 Inch
HPC-300

  • Helicobacter pylori immunoglobulin A (IgA)/IgG antibody IVD, control
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