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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 Directigen™ Neisseria meningitidis Test Kit Groups A, C, Y and W135
BECTON, DICKINSON AND COMPANY
250160
Not in Commercial Distribution

  • 00382902501602 ()
250160

  • Multiple meningitis-associated bacteria antigen IVD, kit, agglutination
Kit BD MAX EXT Enteric Bacterial Panel
BECTON, DICKINSON AND COMPANY
443812
In Commercial Distribution

  • 00382904438128 ()
443812

  • Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT)
Drill Sleeve Insert, MIS
Stryker GmbH
542116
In Commercial Distribution

  • 07613327625066 ()
542116

  • Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT)
Kit BD Max Enteric Bacterial Panel USA
Geneohm Sciences Canada Inc
443378
Not in Commercial Distribution

  • 00382904433789 ()
443378

  • Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT)
Kit BD MAX Enteric Bacterial Panel
BECTON, DICKINSON AND COMPANY
442963
In Commercial Distribution

  • 00382904429638 ()
442963

  • Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Mkl Diagnostics AB
10-5593-12
In Commercial Distribution

  • 07350049850238 ()


  • Multiple meningitis-associated bacteria antigen IVD, control
No Description
Mkl Diagnostics AB
10-5592-12
In Commercial Distribution

  • 07350049850221 ()
10-5592-12

  • Multiple meningitis-associated bacteria antigen IVD, kit, agglutination
M12016 - Escherichia coli Monovalent O Antiserum - Factor O111 - 2ml
MAST GROUP LIMITED
M12016
In Commercial Distribution

  • 15060392376260 ()
M12016

  • Escherichia coli multiple strain culture isolate antigen IVD, kit, agglutination
M12014 - Escherichia coli Monovalent O Antiserum - Factor O26 - 2ml
MAST GROUP LIMITED
M12014
In Commercial Distribution

  • 15060392376253 ()
M12014

  • Escherichia coli multiple strain culture isolate antigen IVD, kit, agglutination
No Description
Hologic, Inc.
PROGASTRO SSCS ASSAY
Not in Commercial Distribution

  • 15420045506350 ()
303278

  • Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT)
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