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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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AmpliVue Bordetella Assay
QUIDEL CORPORATION
Bordetella Assay
Not in Commercial Distribution

  • 30014613312093 ()
M209

  • Multiple Bordetella species nucleic acid IVD, kit, nucleic acid technique (NAT)
Solana Bordetella Complete
DIAGNOSTIC HYBRIDS, INC.
M308
In Commercial Distribution

  • 30014613336167 ()
M308

  • Multiple Bordetella species nucleic acid IVD, kit, nucleic acid technique (NAT)
BD Difco™ Bordetella Parapertussis Antiserum
BECTON, DICKINSON AND COMPANY
223101
In Commercial Distribution

  • 00382902231011 ()

  • Total Volume: 1 Milliliter
223101

  • Multiple Bordetella species antigen IVD, reagent
BD Difco™ Bordetella Pertussis Antiserum
BECTON, DICKINSON AND COMPANY
223091
In Commercial Distribution

  • 00382902230915 ()

  • Total Volume: 1 Milliliter
223091

  • Multiple Bordetella species antigen IVD, reagent
Nucleic acid sequences, which, through specific binding or chemical reaction with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens
LUMINEX CORPORATION
3902
In Commercial Distribution

  • 00840487101247 ()
3902

  • Multiple Bordetella species nucleic acid IVD, reagent
Nucleic acid sequences, which, through specific binding or chemical reaction with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens
LUMINEX CORPORATION
3921
Not in Commercial Distribution

  • 00840487100196 ()
3921

  • Multiple Bordetella species nucleic acid IVD, reagent
Apolipoprotein B (APO B) Atellica CH - RGT 300T
Siemens Healthcare Diagnostics Inc.
11097626
In Commercial Distribution

  • 00630414596235 ()
11097626

  • Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry
No Description
THE BINDING SITE GROUP LIMITED
NK086.S
In Commercial Distribution

  • 05051700016889 ()


  • Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry
Apolipoprotein B - ADVIA Chem. - RGT - 2x85 tests
Siemens Healthcare Diagnostics Inc.
10318207
In Commercial Distribution

  • 00630414517674 ()
3055068

  • Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry
No Description
RANDOX LABORATORIES LIMITED
LP8008
In Commercial Distribution

  • 05055273209228 ()


  • Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry
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