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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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QC Sets and Panels: Helix Elite™ - 70845357042704

QC Sets and Panels: Helix Elite™ Comprehensive Enteric Bacterial Control Panel (Inactivated Pellet)
MICROBIOLOGICS INC.
8231
In Commercial Distribution

  • 70845357042704 ()
8231

  • Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, control

BD Directigen™ Specimen Buffer Solution - 00382902563914

BD Directigen™ Specimen Buffer Solution
BECTON, DICKINSON AND COMPANY
256391
Not in Commercial Distribution

  • 00382902563914 ()

  • Total Volume: 8 Milliliter
256391

  • Multiple meningitis-associated bacteria antigen IVD, kit, agglutination

BD Directigen™ Neisseria meningitidis Group B and E. coli K1 Test Kit - 00382902555605

BD Directigen™ Neisseria meningitidis Group B and E. coli K1 Test Kit
BECTON, DICKINSON AND COMPANY
255560
Not in Commercial Distribution

  • 00382902555605 ()
255560

  • Multiple meningitis-associated bacteria antigen IVD, kit, agglutination

BD Directigen™ Group B Strep Test - 00382902554608

BD Directigen™ Group B Strep Test
BECTON, DICKINSON AND COMPANY
255460
Not in Commercial Distribution

  • 00382902554608 ()
255460

  • Multiple meningitis-associated bacteria antigen IVD, kit, agglutination

BD Directigen™ Meningitis Combo Test Cards - 00382902524809

BD Directigen™ Meningitis Combo Test Cards
BECTON, DICKINSON AND COMPANY
252480
Not in Commercial Distribution

  • 00382902524809 ()
252480

  • Multiple meningitis-associated bacteria antigen IVD, kit, agglutination

BD Directigen™ Meningitis Combo Test Kit - 00382902523604

BD Directigen™ Meningitis Combo Test Kit
BECTON, DICKINSON AND COMPANY
252360
Not in Commercial Distribution

  • 00382902523604 ()
252360

  • Multiple meningitis-associated bacteria antigen IVD, kit, agglutination

BD Directigen™ H. influenzae type b Test Kit - 00382902522607

BD Directigen™ H. influenzae type b Test
BECTON, DICKINSON AND COMPANY
252260
Not in Commercial Distribution

  • 00382902522607 ()
252260

  • Multiple meningitis-associated bacteria antigen IVD, kit, agglutination

BD Directigen™ S. pneumoniae Test - 00382902519607

BD Directigen™ S. pneumoniae Test
BECTON, DICKINSON AND COMPANY
251960
Not in Commercial Distribution

  • 00382902519607 ()
251960

  • Multiple meningitis-associated bacteria antigen IVD, kit, agglutination

BD Directigen™ Neisseria meningitidis Test Kit Groups A, C, Y and W135 - 00382902501602

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

BD MAX™ Extended Enteric Bacterial Panel - 00382904438128

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)
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