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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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LEFLUNOMIDE HIGH LEVEL 1
UTAK LABORATORIES, INC.
LEFLU HIGH L1
In Commercial Distribution

  • B800LEFLUHIGHL15 ()
  • B800LEFLUHIGHL10 ()

  • Total Volume: 0.1 Milliliter
LEFLU HIGH L1

  • Multiple-type clinical chemistry analyte profile IVD, control
LEAD 70 UG/DL
UTAK LABORATORIES, INC.
LEAD 70 WB ACL
In Commercial Distribution

  • B800LEAD70WBACL5 ()
  • B800LEAD70WBACL0 ()

  • Total Volume: 3 Milliliter
LEAD 70 WB ACL

  • Multiple-type clinical chemistry analyte profile IVD, control
LEAD LEVEL 5
UTAK LABORATORIES, INC.
LEAD 5 WB F LGC
In Commercial Distribution

  • B800LEAD5WBFLGC0 ()

  • Total Volume: 5 Milliliter
LEAD 5 WB F LGC

  • Multiple-type clinical chemistry analyte profile IVD, control
LEAD LEVEL 5
UTAK LABORATORIES, INC.
LEAD 5 WB F CH
In Commercial Distribution

  • B800LEAD5WBFCH5 ()
  • B800LEAD5WBFCH0 ()

  • Total Volume: 0.5 Milliliter
LEAD 5 WB F CH

  • Multiple-type clinical chemistry analyte profile IVD, control
LEAD LEVEL 4
UTAK LABORATORIES, INC.
LEAD 4 WB F UMMC
In Commercial Distribution

  • B800LEAD4WBFUMMC5 ()
  • B800LEAD4WBFUMMC0 ()

  • Total Volume: 10 Milliliter
LEAD 4 WB F UMMC

  • Multiple-type clinical chemistry analyte profile IVD, control
LEAD LEVEL 4
UTAK LABORATORIES, INC.
LEAD 3 WB F UCI
In Commercial Distribution

  • B800LEAD4WBFUCI5 ()
  • B800LEAD4WBFUCI0 ()

  • Total Volume: 3 Milliliter
LEAD 4 WB F UCI

  • Multiple-type clinical chemistry analyte profile IVD, control
LEAD LEVEL 4
UTAK LABORATORIES, INC.
LEAD 4 WB F LGC
In Commercial Distribution

  • B800LEAD4WBFLGC5 ()
  • B800LEAD4WBFLGC0 ()

  • Total Volume: 5 Milliliter
LEAD 4 WB F LGC

  • Multiple-type clinical chemistry analyte profile IVD, control
LEAD LEVEL 4 V4
UTAK LABORATORIES, INC.
EAD 4 V4 WB F CH
In Commercial Distribution

  • B800LEAD4V4WBFCH5 ()
  • B800LEAD4V4WBFCH0 ()

  • Total Volume: 0.5 Milliliter
EAD 4 V4 WB F CH

  • Multiple-type clinical chemistry analyte profile IVD, control
LEAD LEVEL 4 V3
UTAK LABORATORIES, INC.
LEAD 4 V3 WB F CH
In Commercial Distribution

  • B800LEAD4V3WBFCH0 ()

  • Total Volume: 0.5 Milliliter
LEAD 4 V3 WB F CH

  • Multiple-type clinical chemistry analyte profile IVD, control
LEAD LEVEL 3
UTAK LABORATORIES, INC.
LEAD 3 WB F UMMC
In Commercial Distribution

  • B800LEAD3WBFUMMC5 ()
  • B800LEAD3WBFUMMC0 ()

  • Total Volume: 10 Milliliter
LEAD 3 WB F UMMC

  • Multiple-type clinical chemistry analyte profile IVD, control
LEAD LEVEL 3
UTAK LABORATORIES, INC.
LEAD 3 WB F UCI
In Commercial Distribution

  • B800LEAD3WBFUCI0 ()

  • Total Volume: 3 Milliliter
LEAD 3 WB F UCI

  • Multiple-type clinical chemistry analyte profile IVD, control
LEAD LEVEL 3
UTAK LABORATORIES, INC.
LEAD 3 WB F LGC
In Commercial Distribution

  • B800LEAD3WBFLGC5 ()
  • B800LEAD3WBFLGC0 ()

  • Total Volume: 5 Milliliter
LEAD 3 WB F LGC

  • Multiple-type clinical chemistry analyte profile IVD, control
LEAD LEVEL 3
UTAK LABORATORIES, INC.
LEAD 3 WB F BCH
In Commercial Distribution

  • B800LEAD3WBFBCH5 ()
  • B800LEAD3WBFBCH0 ()

  • Total Volume: 5 Milliliter
LEAD 3 WB F BCH

  • Multiple-type clinical chemistry analyte profile IVD, control
LEAD LEVEL 3 V4
UTAK LABORATORIES, INC.
LEAD 3 V4 WB F CH
In Commercial Distribution

  • B800LEAD3V4WBFCH5 ()
  • B800LEAD3V4WBFCH0 ()

  • Total Volume: 0.5 Milliliter
LEAD 3 V4 WB F CH

  • Multiple-type clinical chemistry analyte profile IVD, control
LEAD LEVEL 3 V3
UTAK LABORATORIES, INC.
LEAD 3 V3 WB F CH
In Commercial Distribution

  • B800LEAD3V3WBFCH5 ()
  • B800LEAD3V3WBFCH0 ()

  • Total Volume: 0.5 Milliliter
LEAD 3 V3 WB F CH

  • Multiple-type clinical chemistry analyte profile IVD, control
LEAD 30 UG/DL
UTAK LABORATORIES, INC.
LEAD 30 F WB NEPM
In Commercial Distribution

  • B800LEAD30FWBNEPM5 ()
  • B800LEAD30FWBNEPM0 ()

  • Total Volume: 2 Milliliter
LEAD 30 F WB NEPM

  • Multiple-type clinical chemistry analyte profile IVD, control
LEAD LEVEL 2
UTAK LABORATORIES, INC.
LEAD 2 WB F UMMC
In Commercial Distribution

  • B800LEAD2WBFUMMC5 ()
  • B800LEAD2WBFUMMC0 ()

  • Total Volume: 10 Milliliter
LEAD 2 WB F UMMC

  • Multiple-type clinical chemistry analyte profile IVD, control
LEAD LEVEL 2
UTAK LABORATORIES, INC.
LEAD 2 WB F UCI
In Commercial Distribution

  • B800LEAD2WBFUCI5 ()
  • B800LEAD2WBFUCI0 ()

  • Total Volume: 3 Milliliter
LEAD 2 WB F UCI

  • Multiple-type clinical chemistry analyte profile IVD, control
LEAD LEVEL 2
UTAK LABORATORIES, INC.
LEAD 2 WB F LGC
In Commercial Distribution

  • B800LEAD2WBFLGC5 ()
  • B800LEAD2WBFLGC0 ()

  • Total Volume: 5 Milliliter
LEAD 2 WB F LGC

  • Multiple-type clinical chemistry analyte profile IVD, control
LEAD LEVEL 2
UTAK LABORATORIES, INC.
LEAD 2 WB F BCH
In Commercial Distribution

  • B800LEAD2WBFBCH5 ()
  • B800LEAD2WBFBCH0 ()

  • Total Volume: 5 Milliliter
LEAD 2 WB F BCH

  • Multiple-type clinical chemistry analyte profile IVD, control
LEAD 2 V4 WB F CH
UTAK LABORATORIES, INC.
LEAD LEVEL 2 V4
In Commercial Distribution

  • B800LEAD2V4WBFCH5 ()
  • B800LEAD2V4WBFCH0 ()

  • Total Volume: 0.5 Milliliter
LEAD LEVEL 2 V4

  • Multiple-type clinical chemistry analyte profile IVD, control
LEAD LEVEL 2 V3
UTAK LABORATORIES, INC.
LEAD 2 V3 WB F CH
In Commercial Distribution

  • B800LEAD2V3WBFCH5 ()
  • B800LEAD2V3WBFCH0 ()

  • Total Volume: 0.5 Milliliter
LEAD 2 V3 WB F CH

  • Multiple-type clinical chemistry analyte profile IVD, control
LEAD LEVEL 1
UTAK LABORATORIES, INC.
LEAD 1 WB F LGC
In Commercial Distribution

  • B800LEAD1WBFLGC5 ()
  • B800LEAD1WBFLGC0 ()

  • Total Volume: 5 Milliliter
LEAD 1 WB F LGC

  • Multiple-type clinical chemistry analyte profile IVD, control
LAMOTRIGINE PLUS LEVEL 3
UTAK LABORATORIES, INC.
LAMO+ 3 V3 S UCH
In Commercial Distribution

  • B800LAMO3V3SUCH5 ()
  • B800LAMO3V3SUCH0 ()

  • Total Volume: 1.5 Milliliter
LAMO+ 3 V3 S UCH

  • Multiple drugs of abuse IVD, control
LAMOTRIGINE LEVEL 3
UTAK LABORATORIES, INC.
LAMO 3 S F UC
In Commercial Distribution

  • B800LAMO3SFUCI5 ()
  • B800LAMO3SFUCI0 ()

  • Total Volume: 3 Milliliter
LAMO 3 S F UC

  • Multiple-type clinical chemistry analyte profile IVD, control
LAMOTRIGINE PLUS LEVEL 2
UTAK LABORATORIES, INC.
LAMO+ 2 V3 S UCH
In Commercial Distribution

  • B800LAMO2V3SUCH5 ()
  • B800LAMO2V3SUCH0 ()

  • Total Volume: 1.5 Milliliter
LAMO+ 2 V3 S UCH

  • Multiple drugs of abuse IVD, control
LAMOTRIGINE LEVEL 2
UTAK LABORATORIES, INC.
LAMO 2 S F UCI
In Commercial Distribution

  • B800LAMO2SFUCI5 ()
  • B800LAMO2SFUCI0 ()

  • Total Volume: 17 Milliliter
LAMO 2 S F UCI

  • Multiple-type clinical chemistry analyte profile IVD, control
LAMOTRIGINE PLUS LEVEL 1
UTAK LABORATORIES, INC.
LAMO+ 1 V3 S UCHLAMO+ 1 V3 S UCH
In Commercial Distribution

  • B800LAMO1V3SUCH5 ()
  • B800LAMO1V3SUCH0 ()

  • Total Volume: 1.5 Milliliter
LAMO+ 1 V3 S UCH

  • Multiple drugs of abuse IVD, control
LAMOTRIGINE LEVEL 1
UTAK LABORATORIES, INC.
LAMO 1 S F UCI
In Commercial Distribution

  • B800LAMO1SFUCI5 ()
  • B800LAMO1SFUCI0 ()

  • Total Volume: 3 Milliliter
LAMO 1 S F UCI

  • Multiple-type clinical chemistry analyte profile IVD, control
KIT DAU V4
UTAK LABORATORIES, INC.
KIT DAU V4 POTM
In Commercial Distribution

  • B800KITDAUV4POTM5 ()
  • B800KITDAUV4POTM0 ()

  • Total Volume: 20 Milliliter
KIT DAU V4 POTM

  • Multiple-type clinical chemistry analyte profile IVD, control
KIT DAU
UTAK LABORATORIES, INC.
KIT DAU POTM
In Commercial Distribution

  • B800KITDAUPOTM5 ()
  • B800KITDAUPOTM0 ()

  • Total Volume: 20 Milliliter
KIT DAU POTM

  • Multiple-type clinical chemistry analyte profile IVD, control
ISAVUCONAZOLE PLUS CONTROL 1 V2
UTAK LABORATORIES, INC.
ISA+ CONT 1 V2 S F UCSF
In Commercial Distribution

  • B800ISACONT1V2SFUCSF5 ()
  • B800ISACONT1V2SFUCSF0 ()

  • Total Volume: 1 Milliliter
ISA+ CONT 1 V2 S F UCSF

  • Multiple-type clinical chemistry analyte profile IVD, control
ISAVUCONAZOLE PLUS CALIBRATOR 6 V2
UTAK LABORATORIES, INC.
ISA+ CAL 6 V2 S F UCSF
In Commercial Distribution

  • B800ISACAL6V2SFUCSF5 ()
  • B800ISACAL6V2SFUCSF0 ()

  • Total Volume: 1 Milliliter
ISA+ CAL 6 V2 S F UCSF

  • Multiple-type clinical chemistry analyte profile IVD, control
IMMUNOSUPPRESSANTS LEVEL 4
UTAK LABORATORIES, INC.
IMMUN 4 WB F UNC
In Commercial Distribution

  • B800IMMUN4WBFUNC5 ()
  • B800IMMUN4WBFUNC0 ()

  • Total Volume: 2.5 Milliliter
IMMUN 4 WB F UNC

  • Multiple-type clinical chemistry analyte profile IVD, control
IMMUNOSUPPRESSANTS LEVEL 2
UTAK LABORATORIES, INC.
IMMUN 2 WB F UNC
In Commercial Distribution

  • B800IMMUN2WBFUNC5 ()
  • B800IMMUN2WBFUNC0 ()

  • Total Volume: 2.5 Milliliter
IMMUN 2 WB F UNC

  • Multiple-type clinical chemistry analyte profile IVD, control
IMMUNOSUPPRESSANTS BLANK
UTAK LABORATORIES, INC.
IMMUN 0 WB F UNC
In Commercial Distribution

  • B800IMMUN0WBFUNC5 ()
  • B800IMMUN0WBFUNC0 ()

  • Total Volume: 2.5 Milliliter
IMMUN 0 WB F UNC

  • Multiple-type clinical chemistry analyte profile IVD, control
IMMUNOSUPPRESSANTS LEVEL 2
UTAK LABORATORIES, INC.
IMMU 2 V2 WB F PH
In Commercial Distribution

  • B800IMMU2V2WBFPH5 ()
  • B800IMMU2V2WBFPH0 ()
IMMU 2 V2 WB F PH

  • Multiple-type clinical chemistry analyte profile IVD, control
IMMUNOASSAY CUTOFF
UTAK LABORATORIES, INC.
IA CUT U F PMG
In Commercial Distribution

  • B800IACUTUFPMG5 ()
  • B800IACUTUFPMG0 ()

  • Total Volume: 5 Milliliter
IA CUT U F PMG

  • Multiple therapeutic drugs/drugs of abuse IVD, control
HYDROXYPROGESTERONE LEVEL 1
UTAK LABORATORIES, INC.
HPROG 1 S F FUMC
In Commercial Distribution

  • B800HPROG1SFFUMC5 ()
  • B800HPROG1SFFUMC0 ()

  • Total Volume: 2 Milliliter
HPROG 1 S F FUMC

  • Multiple-type clinical chemistry analyte profile IVD, control
HMSB LEVEL 3
UTAK LABORATORIES, INC.
HMSB 3 WB F MAYO
In Commercial Distribution

  • B800HMSB3WBFMAYO05 ()
  • B800HMSB3WBFMAYO0 ()

  • Total Volume: 5 Milliliter
HMSB 3 WB F MAYO

  • Multiple-type clinical chemistry analyte profile IVD, control
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