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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 - 10845357040142

Lab-Elite™ CRM S. diarizonae ATCC 12325™
MICROBIOLOGICS INC.
01054-CRM
Not in Commercial Distribution

  • 10845357040142 ()
01054-CRM

  • Multiple bacteria species culture isolate identification control IVD, kit

Lab-Elite™ CRM - 10845357040128

Lab-Elite™ CRM B. laterosporus ATCC 64™
MICROBIOLOGICS INC.
0144-CRM
Not in Commercial Distribution

  • 10845357040128 ()
0144-CRM

  • Multiple bacteria species culture isolate identification control IVD, kit

LYFO DISK™ - 10845357040104

LYFO DISK™ V. parahaemolyticus (o2:k3) NCTC 10885
MICROBIOLOGICS INC.
01236L
In Commercial Distribution

  • 10845357040104 ()
01236L

  • Multiple bacteria species culture isolate identification control IVD, kit

LYFO DISK™ - 10845357040067

LYFO DISK™ S. agalactiae (III) ATCC BAA-22™
MICROBIOLOGICS INC.
01234L
In Commercial Distribution

  • 10845357040067 ()
01234L

  • Multiple bacteria species culture isolate identification control IVD, kit

KWIK-STIK™ - 10845357040050

KWIK-STIK™ S. agalactiae (III) ATCC BAA-22™
MICROBIOLOGICS INC.
01234U
In Commercial Distribution

  • 20845357040057 ()
  • 10845357040050 ()
  • 30845357040078 ()
01234U

  • Multiple bacteria species culture isolate identification control IVD, kit

KWIK-STIK™ - 10845357040029

KWIK-STIK™ S. dysenteriae ATCC 13313™
MICROBIOLOGICS INC.
01235U
In Commercial Distribution

  • 20845357040026 ()
  • 10845357040029 ()
  • 30845357040030 ()
01235U

  • Multiple bacteria species culture isolate identification control IVD, kit

Lab-Elite™ CRM - 10845357040005

Lab-Elite™ CRM S. Bispebjerg ATCC 9842™
MICROBIOLOGICS INC.
01056-CRM
Not in Commercial Distribution

  • 10845357040005 ()
01056-CRM

  • Multiple bacteria species culture isolate identification control IVD, kit

Lab-Elite™ CRM - 10845357039986

Lab-Elite™ CRM L. monocytogenes (4b) ATCC 19115™
MICROBIOLOGICS INC.
0687-CRM
Not in Commercial Distribution

  • 10845357039986 ()
0687-CRM

  • Multiple bacteria species culture isolate identification control IVD, kit

KWIK-STIK™ - 10845357039184

KWIK-STIK™ N. gonorrhoeae CDC F-28
MICROBIOLOGICS INC.
01217U
Not in Commercial Distribution

  • 30845357039195 ()
  • 10845357039184 ()
  • 20845357039181 ()
01217U

  • Multiple bacteria species culture isolate identification control IVD, kit

LYFO DISK™ - 10845357039177

LYFO DISK™ N. gonorrhoeae CDC F-18
MICROBIOLOGICS INC.
01216L
Not in Commercial Distribution

  • 10845357039177 ()
01216L

  • Multiple bacteria species culture isolate identification control IVD, kit
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