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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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LYFO DISK™ - 10845357037081

LYFO DISK™ S. lugdunensis NCTC 7990
MICROBIOLOGICS INC.
01150L
In Commercial Distribution

  • 10845357037081 ()
01150L

  • Multiple bacteria species culture isolate identification control IVD, kit

KWIK-STIK™ - 10845357037067

KWIK-STIK™ S. lugdunensis NCTC 7990
MICROBIOLOGICS INC.
01150U
In Commercial Distribution

  • 20845357037064 ()
  • 10845357037067 ()
  • 30845357037078 ()
01150U

  • Multiple bacteria species culture isolate identification control IVD, kit

LYFO DISK™ - 10845357037050

LYFO DISK™ K. pneumoniae NCTC 13442
MICROBIOLOGICS INC.
01148L
In Commercial Distribution

  • 10845357037050 ()
01148L

  • Multiple bacteria species culture isolate identification control IVD, kit

KWIK-STIK™ - 10845357037036

KWIK-STIK™ K. pneumoniae NCTC 13442
MICROBIOLOGICS INC.
01148U
In Commercial Distribution

  • 20845357037033 ()
  • 10845357037036 ()
  • 30845357037047 ()
01148U

  • Multiple bacteria species culture isolate identification control IVD, kit

Lab-Elite™ CRM - 10845357037012

Lab-Elite™ CRM C. sporogenes ATCC 19404™
MICROBIOLOGICS INC.
0317-CRM
Not in Commercial Distribution

  • 10845357037012 ()
0317-CRM

  • Multiple bacteria species culture isolate identification control IVD, kit

Lab-Elite™ CRM - 10845357037005

Lab-Elite™ CRM S. Typhimurium ATCC 13311™
MICROBIOLOGICS INC.
0421-CRM
Not in Commercial Distribution

  • 10845357037005 ()
0421-CRM

  • Multiple bacteria species culture isolate identification control IVD, kit

Lab-Elite™ CRM - 10845357036985

Lab-Elite™ CRM L. monocytogenes ATCC 15313™
MICROBIOLOGICS INC.
0727-CRM
Not in Commercial Distribution

  • 10845357036985 ()
0727-CRM

  • Multiple bacteria species culture isolate identification control IVD, kit

Lab-Elite™ CRM - 10845357036978

Lab-Elite™ CRM H. influenzae (b) ATCC 10211™
MICROBIOLOGICS INC.
0441-CRM
Not in Commercial Distribution

  • 10845357036978 ()
0441-CRM

  • Multiple bacteria species culture isolate identification control IVD, kit

Lab-Elite™ CRM - 10845357036961

Lab-Elite™ CRM C. jejuni ATCC 33560™
MICROBIOLOGICS INC.
0111-CRM
Not in Commercial Distribution

  • 10845357036961 ()
0111-CRM

  • Multiple bacteria species culture isolate identification control IVD, kit

Lab-Elite™ CRM - 10845357036954

Lab-Elite™ CRM P. multocida ATCC 12945™
MICROBIOLOGICS INC.
0668-CRM
Not in Commercial Distribution

  • 10845357036954 ()
0668-CRM

  • Multiple bacteria species culture isolate identification control IVD, kit
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