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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OPIATES 50 NG/ML
UTAK LABORATORIES, INC.
OPIA 50 S LHS
In Commercial Distribution

  • B800OPIA50SLHS5 ()
  • B800OPIA50SLHS0 ()

  • Total Volume: 3 Milliliter
OPIA 50 S LHS

  • Multiple drugs of abuse IVD, control
OPIATES 100 NG/ML
UTAK LABORATORIES, INC.
OPIA 100 S LHS
In Commercial Distribution

  • B800OPIA100SLHS5 ()
  • B800OPIA100SLHS0 ()

  • Total Volume: 3 Milliliter
OPIA 100 S LHS

  • Multiple drugs of abuse IVD, control
NIFEDIPINE PLUS
UTAK LABORATORIES, INC.
NIF+ S F EBS
In Commercial Distribution

  • B800NIFSFEBS5 ()
  • B800NIFSFEBS0 ()

  • Total Volume: 1 Milliliter
NIF+ S F EBS

  • Multiple drugs of abuse IVD, control
NIDA LOW
UTAK LABORATORIES, INC.
NIDA LOW V2 F CRL
In Commercial Distribution

  • B800NIDALOWV2FCRL5 ()
  • B800NIDALOWV2FCRL0 ()

  • Total Volume: 120 Milliliter
NIDA LOW V2 F CRL

  • Multiple drugs of abuse IVD, control
NIDA CUTOFF
UTAK LABORATORIES, INC.
NIDA CUT V2 F CRL
In Commercial Distribution

  • B800NIDACUTV2FCRL5 ()
  • B800NIDACUTV2FCRL0 ()

  • Total Volume: 120 Milliliter
NIDA CUT V2 F CRL

  • Multiple drugs of abuse IVD, control
MPA PLUS LEVEL 2
UTAK LABORATORIES, INC.
MPA+ 2 P V1 F UM
In Commercial Distribution

  • B800MPA2PV1FUM5 ()
  • B800MPA2PV1FUM0 ()

  • Total Volume: 0.5 Milliliter
MPA+ 2 P V1 F UM

  • Multiple drugs of abuse IVD, control
MPA PLUS LEVEL 1
UTAK LABORATORIES, INC.
MPA+ 1 P V1 F UM
In Commercial Distribution

  • B800MPA1PV1FUM5 ()
  • B800MPA1PV1FUM0 ()

  • Total Volume: 0.5 Milliliter
MPA+ 1 P V1 F UM

  • Multiple drugs of abuse IVD, control
MORPHINE GLUCURONIDE PLUS
UTAK LABORATORIES, INC.
MOR GLUC+ U F USDTL
In Commercial Distribution

  • B800MORGLUCUFUSDTL5 ()
  • B800MORGLUCUFUSDTL0 ()

  • Total Volume: 50 Milliliter
MOR GLUC+ U F USDTL

  • Multiple drugs of abuse IVD, control
MITOTANE LEVEL 1
UTAK LABORATORIES, INC.
MITO 1 SHP MAYO
In Commercial Distribution

  • B800MITO1SHPMAYO5 ()
  • B800MITO1SHPMAYO0 ()

  • Total Volume: 3 Milliliter
MITO 1 SHP MAYO

  • Multiple drugs of abuse IVD, control
METALS MID
UTAK LABORATORIES, INC.
MET MID WB F IL
In Commercial Distribution

  • B800METMIDWBFIL5 ()
  • B800METMIDWBFIL0 ()

  • Total Volume: 3 Milliliter
MET MID WB F IL

  • Multiple drugs of abuse IVD, control
METALS LOW
UTAK LABORATORIES, INC.
MET LOW WB F IL
In Commercial Distribution

  • B800METLOWWBFIL5 ()
  • B800METLOWWBFIL0 ()

  • Total Volume: 3 Milliliter
MET LOW WB F IL

  • Multiple drugs of abuse IVD, control
METHAMPHETAMINE PLUS
UTAK LABORATORIES, INC.
METH+ P UCD
In Commercial Distribution

  • B800METHPUCD5 ()
  • B800METHPUCD0 ()

  • Total Volume: 5 Milliliter
METH+ P UCD

  • Multiple drugs of abuse IVD, control
METALS HIGH
UTAK LABORATORIES, INC.
MET HIGH WB F IL
In Commercial Distribution

  • B800METHIGHWBFIL5 ()
  • B800METHIGHWBFIL0 ()

  • Total Volume: 3 Milliliter
MET HIGH WB F IL

  • Multiple drugs of abuse IVD, control
METHAMPHETAMINES CALIBRATOR 4
UTAK LABORATORIES, INC.
METH CAL 4 U IMMU
In Commercial Distribution

  • B800METHCAL4UIMMU0 ()

  • Total Volume: 4 Milliliter
METH CAL 4 U IMMU

  • Multiple drugs of abuse IVD, control
METHAMPHETAMINES CALIBRATOR 3
UTAK LABORATORIES, INC.
METH CAL 3 U IMMU
In Commercial Distribution

  • B800METHCAL3UIMMU0 ()

  • Total Volume: 4 Milliliter
METH CAL 3 U IMMU

  • Multiple drugs of abuse IVD, control
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
METHAMPHETAMINES CALIBRATOR 1
UTAK LABORATORIES, INC.
METH CAL 1 U IMMU
In Commercial Distribution

  • B800METHCAL1UIMMU0 ()

  • Total Volume: 4 Milliliter
METH CAL 1 U IMMU

  • Multiple drugs of abuse IVD, control
MD LABS 43 DRUGS LOW
UTAK LABORATORIES, INC.
MD LABS 43 LOW
In Commercial Distribution

  • B800MDLABS43LOW5 ()
  • B800MDLABS43LOW0 ()

  • Total Volume: 1 Milliliter
MD LABS 43 LOW

  • Multiple drugs of abuse IVD, control
MD LABS 43 DRUGS HIGH
UTAK LABORATORIES, INC.
MD LABS 43 HIGH
In Commercial Distribution

  • B800MDLABS43HIGH5 ()
  • B800MDLABS43HIGH0 ()

  • Total Volume: 1 Milliliter
MD LABS 43 HIGH

  • Multiple drugs of abuse IVD, control
LEFLUNOMIDE HIGH LEVEL 3
UTAK LABORATORIES, INC.
LEFLU HIGH L3 V2
In Commercial Distribution

  • B800LEFLUHIGHL3V25 ()
  • B800LEFLUHIGHL3V20 ()

  • Total Volume: 0.1 Milliliter
LEFLU HIGH L3 V2

  • Multiple drugs of abuse IVD, control
LEFLUNOMIDE HIGH LEVEL 2
UTAK LABORATORIES, INC.
LEFLU HIGH L2 V2
In Commercial Distribution

  • B800LEFLUHIGHL2V25 ()
  • B800LEFLUHIGHL2V20 ()

  • Total Volume: 0.1 Milliliter
LEFLU HIGH L2 V2

  • Multiple drugs of abuse IVD, control
LEFLUNOMIDE HIGH LEVEL 1
UTAK LABORATORIES, INC.
LEFLU HIGH L1 V2
In Commercial Distribution

  • B800LEFLUHIGHL1V25 ()
  • B800LEFLUHIGHL1V20 ()

  • Total Volume: 0.1 Milliliter
LEFLU HIGH L1 V2

  • Multiple drugs of abuse 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 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 20 UG/ML
UTAK LABORATORIES, INC.
LAMO 20 NYP
In Commercial Distribution

  • B800LAMO20NYP5 ()
  • B800LAMO20NYP0 ()

  • Total Volume: 5 Milliliter
LAMO 20 NYP

  • Multiple drugs of abuse 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
IMMUNOASSAY LEVEL 3
UTAK LABORATORIES, INC.
IMMUNO 3 V2 ARUP
In Commercial Distribution

  • B800IMMUNO3V2ARUP0 ()

  • Total Volume: 5 Milliliter
IMMUNO 3 V2 ARUP

  • Multiple drugs of abuse IVD, control
IMMUNOASSAY LEVEL 2
UTAK LABORATORIES, INC.
IMMUNO 2 V2 ARUP
In Commercial Distribution

  • B800IMMUNO2V2ARUP5 ()
  • B800IMMUNO2V2ARUP0 ()

  • Total Volume: 5 Milliliter
IMMUNO 2 V2 ARUP

  • Multiple drugs of abuse IVD, control
IMMUNOASSAY LEVEL 1
UTAK LABORATORIES, INC.
IMMUNO 1 V2 ARUP
In Commercial Distribution

  • B800IMMUNO1V2ARUP5 ()
  • B800IMMUNO1V2ARUP0 ()

  • Total Volume: 5 Milliliter
IMMUNO 1 V2 ARUP

  • Multiple drugs of abuse IVD, control
HYDROXYBUTYRIC 250 UG/ML
UTAK LABORATORIES, INC.
HYDROXYBUT 250 WB AM
In Commercial Distribution

  • B800HYDROXYBUT250WBAM5 ()
  • B800HYDROXYBUT250WBAM0 ()

  • Total Volume: 3 Milliliter
HYDROXYBUT 250 WB AM

  • Multiple drugs of abuse IVD, control
HIV INFECTION TDM QC V3
UTAK LABORATORIES, INC.
HIV TDM QC V3 SL
In Commercial Distribution

  • B800HIVTDMQCV3SL5 ()
  • B800HIVTDMQCV3SL0 ()

  • Total Volume: 3 Milliliter
HIV TDM QC V3 SL

  • Multiple drugs of abuse IVD, control
HALLUCINOGENS LEVEL 1
UTAK LABORATORIES, INC.
HALL 1 U OGL
In Commercial Distribution

  • B800HALL1UOGL5 ()
  • B800HALL1UOGL0 ()

  • Total Volume: 5 Milliliter
HALL 1 U OGL

  • Multiple drugs of abuse IVD, control
GHB 40 UG/ML
UTAK LABORATORIES, INC.
GHB 40 U NJSP
In Commercial Distribution

  • B800GHB40UNJSP5 ()
  • B800GHB40UNJSP0 ()

  • Total Volume: 5 Milliliter
GHB 40 U NJSP

  • Multiple drugs of abuse IVD, control
GHB 2 UG/ML
UTAK LABORATORIES, INC.
GHB 2 WB NJSP
In Commercial Distribution

  • B800GHB2WBNJSP0 ()

  • Total Volume: 5 Milliliter
GHB 2 WB NJSP

  • Multiple drugs of abuse IVD, control
GHB 25 UG/M
UTAK LABORATORIES, INC.
GHB 25 U NJSP
In Commercial Distribution

  • B800GHB25UNJSP5 ()
  • B800GHB25UNJSP0 ()

  • Total Volume: 5 Milliliter
GHB 25 U NJSP

  • Multiple drugs of abuse IVD, control
GHB 20 UG/ML
UTAK LABORATORIES, INC.
GHB 20 WB NJSP
In Commercial Distribution

  • B800GHB20WBNJSP5 ()
  • B800GHB20WBNJSP0 ()

  • Total Volume: 5 Milliliter
GHB 20 WB NJSP

  • Multiple drugs of abuse IVD, control
GHB 10 UG/ML
UTAK LABORATORIES, INC.
GHB 10 WB NJSP
In Commercial Distribution

  • B800GHB10WBNJSP5 ()
  • B800GHB10WBNJSP0 ()

  • Total Volume: 5 Milliliter
GHB 10 WB NJSP

  • Multiple drugs of abuse IVD, control
GHB 10 UG/ML
UTAK LABORATORIES, INC.
GHB 10 U NJSP
In Commercial Distribution

  • B800GHB10UNJSP5 ()
  • B800GHB10UNJSP0 ()

  • Total Volume: 5 Milliliter
GHB 10 U NJSP

  • Multiple drugs of abuse IVD, control
GABAPENTIN PLUS
UTAK LABORATORIES, INC.
GABA+ V V2 WB F MSP
In Commercial Distribution

  • B800GABAVV2WBFMSP5 ()
  • B800GABAVV2WBFMSP0 ()

  • Total Volume: 50 Milliliter
GABA+ V V2 WB F MSP

  • Multiple drugs of abuse IVD, control
FENTANYL PANEL POSITIVE 2
UTAK LABORATORIES, INC.
FENT+ POS2 U KP
In Commercial Distribution

  • B800FENTPOS2UKP5 ()
  • B800FENTPOS2UKP0 ()

  • Total Volume: 10 Microliter
FENT+ POS2 U KP

  • Multiple drugs of abuse IVD, control
FENTANYL PANEL POSITIVE 1
UTAK LABORATORIES, INC.
FENT+ POS1 U KP
In Commercial Distribution

  • B800FENTPOS1UKP5 ()
  • B800FENTPOS1UKP0 ()

  • Total Volume: 10 Microliter
FENT+ POS1 U KP

  • Multiple drugs of abuse IVD, control
FENTANYL NEGATIVE
UTAK LABORATORIES, INC.
FENT NEG F CH
In Commercial Distribution

  • B800FENTNEGFCH5 ()
  • B800FENTNEGFCH0 ()

  • Total Volume: 10 Milliliter
FENT NEG F CH

  • Multiple drugs of abuse IVD, control
FENTANYL KIT
UTAK LABORATORIES, INC.
FENT KIT U F CLC
In Commercial Distribution

  • B800FENTKITUFCLC5 ()
  • B800FENTKITUFCLC0 ()

  • Total Volume: 0.5 Milliliter
FENT KIT U F CLC

  • Multiple drugs of abuse IVD, control
FENTANYL ASSAY QUALITY CONTROL MATERIAL
UTAK LABORATORIES, INC.
FENT KIT U F
In Commercial Distribution

  • B800FENTKITUF5 ()
  • B800FENTKITUF0 ()

  • Total Volume: 0.5 Milliliter
FENT KIT U F

  • Multiple drugs of abuse IVD, control
FENTANYL PLUS LEVEL 5
UTAK LABORATORIES, INC.
FENT+ 5 U QD
In Commercial Distribution

  • B800FENT5UQD5 ()
  • B800FENT5UQD0 ()

  • Total Volume: 20 Milliliter
FENT+ 5 U QD

  • Multiple drugs of abuse IVD, control
FENTANYL PLUS LEVEL 4
UTAK LABORATORIES, INC.
FENT+ 4 U QD
In Commercial Distribution

  • B800FENT4UQD5 ()
  • B800FENT4UQD0 ()

  • Total Volume: 20 Milliliter
FENT+ 4 U QD

  • Multiple drugs of abuse IVD, control
FENTANYL PLUS LEVEL 3
UTAK LABORATORIES, INC.
FENT+3 U QD
In Commercial Distribution

  • B800FENT3UQD5 ()
  • B800FENT3UQD0 ()

  • Total Volume: 20 Milliliter
FENT+ 3 U QD

  • Multiple drugs of abuse IVD, control
FENTANYL PLUS LEVEL 2
UTAK LABORATORIES, INC.
FENT+ 2 U QD
In Commercial Distribution

  • B800FENT2UQD5 ()
  • B800FENT2UQD0 ()

  • Total Volume: 20 Milliliter
FENT+ 2 U QD

  • Multiple drugs of abuse IVD, control
FENTANYL PLUS LEVEL 2
UTAK LABORATORIES, INC.
FENT+ 2 U ADX
In Commercial Distribution

  • B800FENT2UADX5 ()
  • B800FENT2UADX0 ()

  • Total Volume: 10 Milliliter
FENT+ 2 U ADX

  • Multiple drugs of abuse IVD, control
FENTANYL PLUS LEVEL 2
UTAK LABORATORIES, INC.
FENT+ 2 QD
In Commercial Distribution

  • B800FENT2QD5 ()
  • B800FENT2QD0 ()

  • Total Volume: 4 Milliliter
FENT+ 2 QD

  • Multiple drugs of abuse IVD, control
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