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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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BD Difco™ Bordetella Pertussis Antigen - 00382902258513

BD Difco™ Bordetella Pertussis Antigen
BECTON, DICKINSON AND COMPANY
225851
In Commercial Distribution

  • 00382902258513 ()

  • Total Volume: 5 Milliliter
225851

  • Multiple Bordetella species antigen IVD, control

STRADIS - M7525251581

STERILE SEPARATES - MINOR PROCEDURE DRAPE 76X124
STRADIS MEDICAL, LLC
525-158
Not in Commercial Distribution

  • M7525251581 ()

  • Width: 124 Inch
  • Length: 76 Inch


  • Multiple Bartonella species antibody IVD, kit, fluorescent immunoassay

Quidel Molecular - 30014613311171

QMol Bordetella Control Set
DIAGNOSTIC HYBRIDS, INC.
M117
In Commercial Distribution

  • 30014613311171 ()
M117

  • Multiple Bordetella species nucleic acid IVD, control

STRADIS - M752SS6871351

STERILE SEPARATE HALSTEAD MOSQUITO FORCEP
STRADIS MEDICAL, LLC
SS687-135
Not in Commercial Distribution

  • M752SS6871351 ()


  • Multiple Bartonella species antibody IVD, kit, fluorescent immunoassay

ARIES® Bordetella Assay - 00840487101452

The ARIES® Bordetella Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and identification of Bordetella pertussis (B. pertussis) and Bordetella parapertussis (B. parapertussis) nucleic acid in nasopharyngeal swab (NPS) specimens obtained from individuals suspected of having a respiratory tract infection attributable to B. pertussis or B. parapertussis.
LUMINEX CORPORATION
50-10037
Not in Commercial Distribution

  • 00840487101452 ()


  • Multiple Bordetella species nucleic acid IVD, kit, nucleic acid technique (NAT)

Solana - 30014613336167

Solana Bordetella Complete
DIAGNOSTIC HYBRIDS, INC.
M308
In Commercial Distribution

  • 30014613336167 ()
M308

  • Multiple Bordetella species nucleic acid IVD, kit, nucleic acid technique (NAT)

AmpliVue - 30014613312093

AmpliVue Bordetella Assay
QUIDEL CORPORATION
Bordetella Assay
Not in Commercial Distribution

  • 30014613312093 ()
M209

  • Multiple Bordetella species nucleic acid IVD, kit, nucleic acid technique (NAT)

MultiCode® Bordetella parapertussis Primers - 00840487101247

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

MultiCode® Bordetella holmseii Primers - 00840487100196

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

BD Difco™ Bordetella Parapertussis Antiserum - 00382902231011

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
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