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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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Lab-Elite™ CRM - 10845357033083

Lab-Elite™ CRM E. coli ATCC 11229™
MICROBIOLOGICS INC.
0681-CRM
Not in Commercial Distribution

  • 10845357033083 ()
0681-CRM

  • Multiple bacteria species culture isolate identification control IVD, kit

KWIK-STIK™ Plus - 10845357032666

KWIK-STIK™ Plus E. hirae ATCC 8043™
MICROBIOLOGICS INC.
0650UX
Not in Commercial Distribution

  • 40845357032667 ()
  • 10845357032666 ()
0650UX

  • Multiple bacteria species culture isolate identification control IVD, kit

LYFO DISK™ - 10845357032352

LYFO DISK™ E. faecium ATCC 6057™
MICROBIOLOGICS INC.
01052L
In Commercial Distribution

  • 10845357032352 ()
01052L

  • Multiple bacteria species culture isolate identification control IVD, kit

LYFO DISK™ - 10845357032260

LYFO DISK™ E. coli ATCC 10799™
MICROBIOLOGICS INC.
01050L
In Commercial Distribution

  • 10845357032260 ()
01050L

  • Multiple bacteria species culture isolate identification control IVD, kit

Lab-Elite™ CRM - 10845357032086

Lab-Elite™ CRM E. faecalis ATCC 29212™
MICROBIOLOGICS INC.
0366-CRM
Not in Commercial Distribution

  • 10845357032086 ()
0366-CRM

  • Multiple bacteria species culture isolate identification control IVD, kit

Lab-Elite™ CRM - 10845357032079

Lab-Elite™ CRM E. coli ATCC 8739™
MICROBIOLOGICS INC.
0483-CRM
Not in Commercial Distribution

  • 10845357032079 ()
0483-CRM

  • Multiple bacteria species culture isolate identification control IVD, kit

Lab-Elite™ CRM - 10845357031997

Lab-Elite™ CRM E. coli ATCC 25922™
MICROBIOLOGICS INC.
0335-CRM
Not in Commercial Distribution

  • 10845357031997 ()
0335-CRM

  • Multiple bacteria species culture isolate identification control IVD, kit

LYFO DISK™ - 10845357029406

LYFO DISK™ E. cloacae ATCC BAA-1143™
MICROBIOLOGICS INC.
01018L
In Commercial Distribution

  • 10845357029406 ()
01018L

  • Multiple bacteria species culture isolate identification control IVD, kit

LYFO DISK™ - 10845357024449

LYFO DISK™ E. faecium ATCC 700221™
MICROBIOLOGICS INC.
01000L
In Commercial Distribution

  • 10845357024449 ()
01000L

  • Multiple bacteria species culture isolate identification control IVD, kit

LYFO DISK™ - 10845357023596

LYFO DISK™ E. meningoseptica ATCC 13253™
MICROBIOLOGICS INC.
0971L
In Commercial Distribution

  • 10845357023596 ()
0971L

  • Multiple bacteria species culture isolate identification control IVD, kit
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