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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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Cholesterol Gen.2 - 04015630918430

No Description
Roche Diagnostics GmbH
3039773190
In Commercial Distribution

  • 04015630918430 ()
03039773190

  • Total cholesterol lipid IVD, kit, spectrophotometry

ISE Solution 2 - 04015630915088

No Description
Roche Diagnostics GmbH
20738069122
In Commercial Distribution

  • 04015630915088 ()
20738069122

  • Multiple-type clinical chemistry analyte profile IVD, calibrator

THC CONTROL 2 - B800THCQC2UFWDH0

THC CONTROL 2
UTAK LABORATORIES, INC.
THC QC 2 U F WDH
In Commercial Distribution

  • B800THCQC2UFWDH5 ()
  • B800THCQC2UFWDH0 ()

  • Total Volume: 10 Milliliter
THC QC 2 U F WDH

  • Multiple-type clinical chemistry analyte profile IVD, control

SPIRITS LEVEL 2 - B800SPIRITS2UFOCMEO0

SPIRITS LEVEL 2
UTAK LABORATORIES, INC.
SPIRITS 2 U F OCMEO
In Commercial Distribution

  • B800SPIRITS2UFOCMEO5 ()
  • B800SPIRITS2UFOCMEO0 ()

  • Total Volume: 5 Milliliter
SPIRITS 2 U F OCMEO

  • Multiple-type clinical chemistry analyte profile IVD, control

RT3 LEVEL 2 - B800RT32SFPG0

RT3 LEVEL 2
UTAK LABORATORIES, INC.
RT3 2 S F PG
In Commercial Distribution

  • B800RT32SFPG5 ()
  • B800RT32SFPG0 ()

  • Total Volume: 2.5 Milliliter
RT3 2 S F PG

  • Multiple-type clinical chemistry analyte profile IVD, control

QLOD-WB LEVEL 2 - B800QLODWB2NTL0

QLOD-WB LEVEL 2
UTAK LABORATORIES, INC.
QLOD-WB 2 NTL
In Commercial Distribution

  • B800QLODWB2NTL5 ()
  • B800QLODWB2NTL0 ()

  • Total Volume: 3 Milliliter
QLOD-WB 2 NTL

  • Multiple therapeutic drugs/drugs of abuse IVD, control

QUALITY CONTROL 2 - B800QC2UFOSUMC0

QUALITY CONTROL 2
UTAK LABORATORIES, INC.
QC 2 U F OSUMC
In Commercial Distribution

  • B800QC2UFOSUMC5 ()
  • B800QC2UFOSUMC0 ()

  • Total Volume: 10 Milliliter
QC 2 U F OSUMC

  • Multiple drugs of abuse IVD, control

PHENYTOIN LEVEL 2 - B800PHENY2SMCTL0

PHENYTOIN LEVEL 2
UTAK LABORATORIES, INC.
PHENY 2 S MCTL
In Commercial Distribution

  • B800PHENY2SMCTL5 ()
  • B800PHENY2SMCTL0 ()

  • Total Volume: 5 Milliliter
PHENY 2 S MCTL

  • Multiple-therapy therapeutic drug monitoring IVD, control

OPIATES LEVEL 2 - B800OPI2UFVAMCI0

OPIATES LEVEL 2
UTAK LABORATORIES, INC.
OPI 2 U F VAMCI
In Commercial Distribution

  • B800OPI2UFVAMCI5 ()
  • B800OPI2UFVAMCI0 ()

  • Total Volume: 1 Milliliter
OPI 2 U F VAMCI

  • Multiple therapeutic drugs/drugs of abuse IVD, control

MPA LEVEL 2 - B800MPA2SVPOTM0

MPA LEVEL 2
UTAK LABORATORIES, INC.
MPA 2 S V POTM
In Commercial Distribution

  • B800MPA2SVPOTM5 ()
  • B800MPA2SVPOTM0 ()

  • Total Volume: 5 Milliliter
MPA 2 S V POTM

  • Multiple-type clinical chemistry analyte profile IVD, control

MPA LEVEL 2 - B800MPA2DPFFUMC0

MPA LEVEL 2
UTAK LABORATORIES, INC.
MPA 2 DP F FUMC
In Commercial Distribution

  • B800MPA2DPFFUMC5 ()
  • B800MPA2DPFFUMC0 ()

  • Total Volume: .5 Microliter
MPA 2 DP F FUMC

  • Multiple-therapy therapeutic drug monitoring IVD, control

METHAMPHETAMINES CALIBRATOR 2 - B800METHCAL2UIMMU0

METHAMPHETAMINES CALIBRATOR 2
UTAK LABORATORIES, INC.
METH CAL 2 U IMMU
In Commercial Distribution

  • B800METHCAL2UIMMU0 ()

  • Total Volume: 4 Milliliter
METH CAL 2 U IMMU

  • Multiple drugs of abuse IVD, control

METHANOL PLUS 2 - B800METH2UCD0

METHANOL PLUS 2
UTAK LABORATORIES, INC.
METH+ 2 UCD
In Commercial Distribution

  • B800METH2UCD5 ()
  • B800METH2UCD0 ()

  • Total Volume: 5 Milliliter
METH+ 2 UCD

  • Multiple-type clinical chemistry analyte profile IVD, control

METALS LEVEL 2 - B800MET2WBQD0

METALS LEVEL 1 2
UTAK LABORATORIES, INC.
MET 2 WB QD
In Commercial Distribution

  • B800MET2WBQD5 ()
  • B800MET2WBQD0 ()

  • Total Volume: 5 Milliliter
MET 2 WB QD

  • Multiple-type clinical chemistry analyte profile IVD, control

METALS LEVEL 2 - B800MET2WBMAYO0

METALS LEVEL 2
UTAK LABORATORIES, INC.
MET 2 WB MAYO
In Commercial Distribution

  • B800MET2WBMAYO05 ()
  • B800MET2WBMAYO0 ()

  • Total Volume: 5 Milliliter
MET 2 WB MAYO

  • Multiple-type clinical chemistry analyte profile IVD, control

METALS LEVEL 2 - B800MET2VWBFUCSD0

METALS LEVEL 2
UTAK LABORATORIES, INC.
MET 2 V WB F UCSD
In Commercial Distribution

  • B800MET2VWBFUCSD5 ()
  • B800MET2VWBFUCSD0 ()

  • Total Volume: 3 Milliliter
MET 2 V WB F UCSD

  • Multiple-type clinical chemistry analyte profile IVD, control

METALS LEVEL 2 - B800MET2VV2SFUCSD0

METALS LEVEL 2
UTAK LABORATORIES, INC.
MET 2 V V2 S F UCSD
In Commercial Distribution

  • B800MET2VV2SFUCSD5 ()
  • B800MET2VV2SFUCSD0 ()

  • Total Volume: 3 Milliliter
MET 2 V V2 S F UCSD

  • Multiple-type clinical chemistry analyte profile IVD, control

METALS LEVEL 2 - B800MET2VSFUCSD0

METALS LEVEL 2
UTAK LABORATORIES, INC.
MET 2 V S F UCSD
In Commercial Distribution

  • B800MET2VSFUCSD5 ()
  • B800MET2VSFUCSD0 ()

  • Total Volume: 3 Milliliter
MET 2 V S F UCSD

  • Multiple-type clinical chemistry analyte profile IVD, control

METALS LEVEL 2 - B800MET2SMAYO0

METALS LEVEL 2
UTAK LABORATORIES, INC.
MET 2 S MAYO
In Commercial Distribution

  • B800MET2SMAYO5 ()
  • B800MET2SMAYO0 ()

  • Total Volume: 5 Milliliter
MET 2 S MAYO

  • Multiple-type clinical chemistry analyte profile IVD, control

METFORMIN LEVEL 2 - B800MET2FPEBS0

METFORMIN LEVEL 2
UTAK LABORATORIES, INC.
MET 2 F P EBS
In Commercial Distribution

  • B800MET2FPEBS5 ()
  • B800MET2FPEBS0 ()

  • Total Volume: 5 Milliliter
MET 2 F P EBS

  • Multiple-type clinical chemistry analyte profile IVD, control
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