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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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VPS 2 COM
MAQUET SAS
ARD568407904
Not in Commercial Distribution

  • 03700712400941 ()


  • Operating room light
VPS 1 COM
MAQUET SAS
ARD568407902
Not in Commercial Distribution

  • 03700712400927 ()


  • Operating room light
Vial Fa Bordetella Parapertus 5Ml
BECTON, DICKINSON AND COMPANY
223781
Not in Commercial Distribution

  • 00382902237815 ()
223781

  • Multiple Bordetella species antigen IVD, kit, fluorescent immunoassay
Vial Fa Bordetella Pertussis 5Ml
BECTON, DICKINSON AND COMPANY
223591
Not in Commercial Distribution

  • 00382902235910 ()
223591

  • Multiple Bordetella species antigen IVD, kit, fluorescent immunoassay
Reusable SpO2 Sensor/百特/Soft Tip/Adult/3.0M/045
Unimed Medical Supplies, Inc.
U410S-12
In Commercial Distribution

  • 06945664802451 ()


  • Pulse oximeter probe, reusable
STERILE SEPARATE HALSTEAD MOSQUITO FORCEP
STRADIS MEDICAL, LLC
SS687-135
Not in Commercial Distribution

  • M752SS6871351 ()


  • Multiple Bartonella species antibody IVD, kit, fluorescent immunoassay
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
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
QMol Bordetella Control Set
DIAGNOSTIC HYBRIDS, INC.
M117
In Commercial Distribution

  • 30014613311171 ()
M117

  • Multiple Bordetella species nucleic acid IVD, control
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)
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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