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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™ 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

Phadebact CSF Positive Controls - 07350049850238

No Description
Mkl Diagnostics AB
10-5593-12
In Commercial Distribution

  • 07350049850238 ()


  • Multiple meningitis-associated bacteria antigen IVD, control

Phadebact CSF Test - 07350049850221

No Description
Mkl Diagnostics AB
10-5592-12
In Commercial Distribution

  • 07350049850221 ()
10-5592-12

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

BD Directigen™ Meningitis Test Negative Control Reagent - 30382902523506

BD Directigen™ Meningitis Test Negative Control Reagent
BECTON, DICKINSON AND COMPANY
252350
Not in Commercial Distribution

  • 30382902523506 ()
  • 00382902523505 ()

  • Total Volume: 9 Milliliter
252350

  • Multiple meningitis-associated bacteria antigen IVD, control

N/A - 00840329807368

B&B ABDOMINAL FLAP DEMARCATOR,
BLACK & BLACK SURGICAL, INC.
B62323
In Commercial Distribution

  • 00840329807368 ()
B62323

  • Skin marking guide, reusable
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