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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™ Group B Streptococcus (GBS) Control Panel (Inactivated Swab)
MICROBIOLOGICS INC.
8232
In Commercial Distribution

  • 70845357042735 ()
8232

  • Beta-haemolytic Group B Streptococcus nucleic acid IVD, control
Assayed GBS LB Control Panel
MICROBIOLOGICS INC.
8194 Cepheid Xpert® GBS LB Control Panel
Not in Commercial Distribution

  • 70845357041219 ()
8194

  • Beta-haemolytic Group B Streptococcus nucleic acid IVD, control
QMol GBS Control Set
DIAGNOSTIC HYBRIDS, INC.
M116
In Commercial Distribution

  • 30014613311164 ()
M116

  • Beta-haemolytic Group B Streptococcus nucleic acid IVD, control
Panther Fusion® GBS Controls Kit.
Hologic, Inc.
KIT, GBS CONTROLS, FUSION, IVD
In Commercial Distribution

  • 15420045510906 ()
PRD-04485

  • Beta-haemolytic Group B Streptococcus nucleic acid IVD, control
Blastomyces dermatitidis Antigen (A), 2mL ID/EXO
MICROBIOLOGICS INC.
200250
Not in Commercial Distribution

  • 10634853000022 ()
200250

  • Blastomyces dermatitidis exoantigen IVD, control
Blastomyces dermatitidis Antigen (A), 1mL
MICROBIOLOGICS INC.
200125
Not in Commercial Distribution

  • 10634853000015 ()
200125

  • Blastomyces dermatitidis total antibody IVD, control
BD® CD19 (4G7) PE
Becton, Dickinson And Company
349209
In Commercial Distribution

  • 00382903492091 ()
349209

  • Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)
Bordetella Pertussis IgG kit is an Enzyme Linked Immunosorbent assay (ELISA) for the qualitative detection of specific IgG antibodies to Bordetella pertussis.
SAVYON DIAGNOSTICS LTD
A2231-01M
In Commercial Distribution

  • 07290016332636 ()
A2231-01M

  • Bordetella pertussis immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)
Blood Grouping Reagent
AMERICAN NATIONAL RED CROSS
510205
In Commercial Distribution

  • 00858400005039 ()


  • Anti-Kp^b red blood cell grouping IVD, antibody
This Anti-Jkb reagent is for the in vitro detection and identification of the human Jkb blood group antigen by direct agglutination.
ALBA BIOSCIENCE LIMITED
Z168U
In Commercial Distribution

  • 05060242472527 ()
  • 05060242472510 ()
  • 05060242472534 ()


  • Anti-Jk^b red blood cell grouping IVD, antibody
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