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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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Ovulation Preedictor
FOURSTAR GROUP INC.
11013002B
In Commercial Distribution

  • 00049696712682 ()


  • Varicella-zoster virus (VZV) immunoglobulin A (IgA) antibody IVD, kit, fluorescent immunoassay
No Description
Roche Diagnostics GmbH
08105472190
In Commercial Distribution

  • 07613336133545 ()
08105472190

  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry
"720-420 anti-Cardiolipin IgATest Kit"
DIAMEDIX CORPORATION
720-420
In Commercial Distribution

  • 00817273020235 ()


  • Cryptosporidium parvum immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)
Candida Antiserum, 2mL
MICROBIOLOGICS INC.
200185
Not in Commercial Distribution

  • 10634853000213 ()
200185

  • Multiple Candida species immunoglobulin A (IgA)/IgG/IgM antibody IVD, control
No Description
MONOBIND, INC.
1625-300
In Commercial Distribution

  • 00816870021089 ()

  • Width: 7.75 Inch
1625-300A

  • Helicobacter pylori immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)
VITROS Chemistry Products ASO Reagent
ORTHO-CLINICAL DIAGNOSTICS, INC.
6802218
In Commercial Distribution

  • 10758750002306 ()
  • 20758750002303 ()
6802218

  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry
No Description
DIASORIN SPA
310210
In Commercial Distribution

  • 08056771100212 ()


  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
ARCHITECT HAVAB-G Reagent Kit
Abbott GmbH
6L27-25
In Commercial Distribution

  • 00380740011185 ()
06L2725

  • Hepatitis A virus immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
Quantia ASO
ABBOTT LABORATORIES
06K3851
In Commercial Distribution

  • 00380740156251 ()
06K3851

  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry
Alinity c ASO Reagent Kit 300 Tests
ABBOTT LABORATORIES
01R0621
In Commercial Distribution

  • 00380740153564 ()
01R0621

  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry
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