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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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ImmunoCAP Allergen i217, Allergen component rApi m 10, Honey bee - 07333066015071

ImmunoCAP Allergen i217, Allergen component rApi m 10, Honey bee
Phadia AB
14-6004-01
In Commercial Distribution

  • 07333066015071 ()
14-6004-01

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)

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™ 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™ 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)

BD MAX™ Enteric Bacterial Panel (US/CAN) - 00382904433789

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)

BD MAX™ Enteric Bacterial Panel - 00382904429638

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)
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