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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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KWIK-STIK™ - 10845357040296

KWIK-STIK™ K. pneumoniae CDC AR-0066
MICROBIOLOGICS INC.
01240U
Not in Commercial Distribution

  • 30845357040283 ()
  • 10845357040296 ()
  • 20845357040293 ()
01240U

  • Multiple bacteria species culture isolate identification control IVD, kit

LYFO DISK™ - 10845357040265

LYFO DISK™ N. gonorrhoeae CDC 10328
MICROBIOLOGICS INC.
01239L
Not in Commercial Distribution

  • 10845357040265 ()
01239L

  • Multiple bacteria species culture isolate identification control IVD, kit

LYFO DISK™ - 10845357040234

LYFO DISK™ T. pinophilus ATCC 11797™
MICROBIOLOGICS INC.
01238L
In Commercial Distribution

  • 10845357040234 ()
01238L

  • Multiple bacteria species culture isolate identification control IVD, kit

Lab-Elite™ CRM - 10845357040159

Lab-Elite™ CRM S. diarizonae ATCC 29934™
MICROBIOLOGICS INC.
01045-CRM
Not in Commercial Distribution

  • 10845357040159 ()
01045-CRM

  • Multiple bacteria species culture isolate identification control IVD, kit

Lab-Elite™ CRM - 10845357040135

Lab-Elite™ CRM R. equi ATCC 6939™
MICROBIOLOGICS INC.
0697-CRM
Not in Commercial Distribution

  • 10845357040135 ()
0697-CRM

  • Multiple bacteria species culture isolate identification control IVD, kit

Lab-Elite™ CRM - 10845357040111

Lab-Elite™ CRM B. cereus ATCC 14579™
MICROBIOLOGICS INC.
0200-CRM
Not in Commercial Distribution

  • 10845357040111 ()
0200-CRM

  • Multiple bacteria species culture isolate identification control IVD, kit

KWIK-STIK™ - 10845357040081

KWIK-STIK™ V. parahaemolyticus (o2:k3) NCTC 10885
MICROBIOLOGICS INC.
01236U
In Commercial Distribution

  • 20845357040088 ()
  • 10845357040081 ()
  • 30845357040092 ()
01236U

  • Multiple bacteria species culture isolate identification control IVD, kit

LYFO DISK™ - 10845357040043

LYFO DISK™ S. dysenteriae ATCC 13313™
MICROBIOLOGICS INC.
01235L
In Commercial Distribution

  • 10845357040043 ()
01235L

  • Multiple bacteria species culture isolate identification control IVD, kit

Lab-Elite™ CRM - 10845357040012

Lab-Elite™ CRM C. lari ATCC 35221™
MICROBIOLOGICS INC.
01132-CRM
Not in Commercial Distribution

  • 10845357040012 ()
01132-CRM

  • Multiple bacteria species culture isolate identification control IVD, kit

Lab-Elite™ CRM - 10845357039993

Lab-Elite™ CRM E. faecium ATCC 35667™
MICROBIOLOGICS INC.
0968-CRM
Not in Commercial Distribution

  • 10845357039993 ()
0968-CRM

  • Multiple bacteria species culture isolate identification control IVD, kit
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