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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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Normal Human Serum (Frozen)
UTAK LABORATORIES, INC.
44600-S(500)
In Commercial Distribution

  • B8004460020 ()

  • Total Volume: 500 Milliliter
44600-S(500)

  • Multiple therapeutic drugs/drugs of abuse IVD, control
Ethanol 80mg/dL
UTAK LABORATORIES, INC.
31080
In Commercial Distribution

  • B800310805 ()
  • B800310800 ()

  • Total Volume: 3 Milliliter
31080

  • Ethanol (ETOH) IVD, control
CATECHOLAMINES LEVEL 3
UTAK LABORATORIES, INC.
20209
In Commercial Distribution

  • B800202095 ()
  • B800202090 ()

  • Total Volume: 2 Milliliter
20209

  • Multiple human hormone IVD, control
CATECHOLAMINES LEVEL 2
UTAK LABORATORIES, INC.
20208
In Commercial Distribution

  • B800202085 ()
  • B800202080 ()

  • Total Volume: 2 Milliliter
20208

  • Multiple human hormone IVD, control
CATECHOLAMINES LEVEL 1
UTAK LABORATORIES, INC.
20207
In Commercial Distribution

  • B800202075 ()
  • B800202070 ()

  • Total Volume: 2 Milliliter
20207

  • Multiple human hormone IVD, control
DEXAMETHASONE LEVEL 2
UTAK LABORATORIES, INC.
20198
In Commercial Distribution

  • B800201985 ()
  • B800201980 ()

  • Total Volume: 3 Milliliter
20198

  • Multiple steroid hormone IVD, control
ETG Plus Level 2
UTAK LABORATORIES, INC.
13021
In Commercial Distribution

  • B800130215 ()
  • B800130210 ()

  • Total Volume: 5 Milliliter
13021

  • Ethyl glucuronide (EtG) IVD, control
BLANK HAIR MATRIX
UTAK LABORATORIES, INC.
115110(50) SMXH F AH
In Commercial Distribution

  • B80011511050SMXHFAH5 ()
  • B80011511050SMXHFAH0 ()

  • Total Volume: 50 Milliliter
115110(50) SMXH F AH

  • Multiple-type clinical chemistry analyte profile IVD, control
Fentanyl Analogues 2ng/mL
UTAK LABORATORIES, INC.
10189
In Commercial Distribution

  • B800101895 ()
  • B800101890 ()

  • Total Volume: 3 Milliliter
10189

  • Multiple therapeutic drugs/drugs of abuse IVD, control
BLANK HAIR MATRIX
UTAK LABORATORIES, INC.
034765-0001
In Commercial Distribution

  • B80003476500010 ()

  • Total Volume: 100 Milliliter
BLK HAIR OL

  • Multiple therapeutic drugs/drugs of abuse IVD, control
ZINC PLUS LEVEL 2
UTAK LABORATORIES, INC.
ZINC+ 2 RBC F QDVA
In Commercial Distribution

  • B800ZINC2RBCFQDVA5 ()
  • B800ZINC2RBCFQDVA0 ()

  • Total Volume: 2 Milliliter
ZINC+ 2 RBC F QDVA

  • Multiple-type clinical chemistry analyte profile IVD, control
B800ZINC1RBCFQDVA0
UTAK LABORATORIES, INC.
ZINC+ 1 RBC F QDVA
In Commercial Distribution

  • B800ZINC1RBCFQDVA5 ()
  • B800ZINC1RBCFQDVA0 ()

  • Total Volume: 2 Milliliter
ZINC+ 1 RBC F QDVA

  • Multiple-type clinical chemistry analyte profile IVD, control
XYLAZINE LEVEL 3
UTAK LABORATORIES, INC.
XYL 3 U F YNHH
In Commercial Distribution

  • B800XYL3UFYNHH5 ()
  • B800XYL3UFYNHH0 ()

  • Total Volume: 2.5 Milliliter
XYL 3 U F YNHH

  • Multiple-type clinical chemistry analyte profile IVD, control
XYLAZINE LEVEL 2
UTAK LABORATORIES, INC.
XYL 2 U F YNHH
In Commercial Distribution

  • B800XYL2UFYNHH5 ()
  • B800XYL2UFYNHH0 ()

  • Total Volume: 2.5 Milliliter
XYL 2 U F YNHH

  • Multiple-type clinical chemistry analyte profile IVD, control
XYLAZINE LEVEL 1
UTAK LABORATORIES, INC.
XYL 1 U F YNHH
In Commercial Distribution

  • B800XYL1UFYNHH5 ()
  • B800XYL1UFYNHH0 ()

  • Total Volume: 2.5 Milliliter
XYL 1 U F YNHH

  • Multiple-type clinical chemistry analyte profile IVD, control
HUMAN WHOLE BLOOD POOL B
UTAK LABORATORIES, INC.
WB+ B F CTS 250
In Commercial Distribution

  • B800WBBFCTS2505 ()
  • B800WBBFCTS2500 ()

  • Total Volume: 250 Milliliter
WB+ B F CTS 250

  • Multiple-type clinical chemistry analyte profile IVD, control
HUMAN WHOLE BLOOD POOL A
UTAK LABORATORIES, INC.
WB+ A F CTS 250
In Commercial Distribution

  • B800WBAFCTS2505 ()
  • B800WBAFCTS2500 ()

  • Total Volume: 250 Milliliter
WB+ A F CTS 250

  • Multiple-type clinical chemistry analyte profile IVD, control
VORICONAZOLE LEVEL 3
UTAK LABORATORIES, INC.
VORI 3 DP QC DUMC
In Commercial Distribution

  • B800VORI3DPQCDUMC5 ()
  • B800VORI3DPQCDUMC0 ()

  • Total Volume: 3 Milliliter
VORI 3 DP QC DUMC

  • Multiple-type clinical chemistry analyte profile IVD, control
VORICONAZOLE LEVEL 2
UTAK LABORATORIES, INC.
VORI 2 DP QC DUMC
In Commercial Distribution

  • B800VORI2DPQCDUMC5 ()
  • B800VORI2DPQCDUMC0 ()

  • Total Volume: 3 Milliliter
VORI 2 DP QC DUMC

  • Multiple-type clinical chemistry analyte profile IVD, control
VORICONAZOLE LEVEL 1
UTAK LABORATORIES, INC.
VORI 1 DP QC DUM
In Commercial Distribution

  • B800VORI1DPQCDUMC5 ()
  • B800VORI1DPQCDUMC0 ()

  • Total Volume: 3 Milliliter
VORI 1 DP QC DUM

  • Multiple-type clinical chemistry analyte profile IVD, control
VORICONAZOLE PLUS 3
UTAK LABORATORIES, INC.
VOR+ 3 V2 S F UNC
In Commercial Distribution

  • B800VOR3V2SFUNC5 ()
  • B800VOR3V2SFUNC0 ()

  • Total Volume: 2 Milliliter
VOR+ 3 V2 S F UNC

  • Multiple-therapy therapeutic drug monitoring IVD, control
VORICONAZOLE PLUS 2
UTAK LABORATORIES, INC.
VOR+ 2 V2 S F UNC
In Commercial Distribution

  • B800VOR2V2SFUNC5 ()
  • B800VOR2V2SFUNC0 ()

  • Total Volume: 2 Milliliter
VOR+ 2 V2 S F UNC

  • Multiple-therapy therapeutic drug monitoring IVD, control
VORICONAZOLE PLUS 1
UTAK LABORATORIES, INC.
VOR+ 1 V2 S F UNC
In Commercial Distribution

  • B800VOR1V2SFUNC5 ()
  • B800VOR1V2SFUNC0 ()

  • Total Volume: 2 Milliliter
VOR+ 1 V2 S F UNC

  • Multiple-therapy therapeutic drug monitoring IVD, control
VOLATILES 0.1 G/DL
UTAK LABORATORIES, INC.
VOL WB V2 F FCL
In Commercial Distribution

  • B800VOLWBV2FFCL5 ()
  • B800VOLWBV2FFCL0 ()

  • Total Volume: 0.5 Milliliter
VOL WB V2 F FCL

  • Multiple drugs of abuse IVD, control
VOLATILES
UTAK LABORATORIES, INC.
VOL WB F SLED
In Commercial Distribution

  • B800VOLWBFSLED5 ()
  • B800VOLWBFSLED0 ()

  • Total Volume: 2.5 Milliliter
VOL WB F SLED

  • Multiple-type clinical chemistry analyte profile IVD, control
VOLATILES
UTAK LABORATORIES, INC.
VOL WB F DSH
In Commercial Distribution

  • B800VOLWBFDSH5 ()
  • B800VOLWBFDSH0 ()

  • Total Volume: 5 Milliliter
VOL WB F DSH

  • Multiple-type clinical chemistry analyte profile IVD, control
VOLATILES
UTAK LABORATORIES, INC.
VOL U F OCMEO
In Commercial Distribution

  • B800VOLUFOCMEO5 ()
  • B800VOLUFOCMEO0 ()

  • Total Volume: 50 Milliliter
VOL U F OCMEO

  • Multiple-type clinical chemistry analyte profile IVD, control
VOLATILES
UTAK LABORATORIES, INC.
VOL SMX-VH F OCMEO
In Commercial Distribution

  • B800VOLSMXVHFOCMEO5 ()
  • B800VOLSMXVHFOCMEO0 ()

  • Total Volume: 50 Milliliter
VOL SMX-VH F OCMEO

  • Multiple-type clinical chemistry analyte profile IVD, control
VOLATILES
UTAK LABORATORIES, INC.
VOL S F OCMEO
In Commercial Distribution

  • B800VOLSFOCME5 ()
  • B800VOLSFOCMEO0 ()

  • Total Volume: 50 Milliliter
VOL S F OCMEO

  • Multiple-type clinical chemistry analyte profile IVD, control
VOLATILES HIGH
UTAK LABORATORIES, INC.
VOL HIGH S ULH
In Commercial Distribution

  • B800VOLHIGHSULH5 ()
  • B800VOLHIGHSULH0 ()

  • Total Volume: 5 Milliliter
VOL HIGH S ULH

  • Multiple-type clinical chemistry analyte profile IVD, control
VOLATILES 40 MG/DL
UTAK LABORATORIES, INC.
VOL 40 WB F UM
In Commercial Distribution

  • B800VOL40WBFUM5 ()
  • B800VOL40WBFUM0 ()

  • Total Volume: 5 Milliliter
VOL 40 WB F UM

  • Multiple-type clinical chemistry analyte profile IVD, control
VOLATILES 400 MG/DL V2
UTAK LABORATORIES, INC.
VOL 400 WB F V2 HCMC
In Commercial Distribution

  • B800VOL400WBFV2HCMC5 ()
  • B800VOL400WBFV2HCMC0 ()

  • Total Volume: 3 Milliliter
VOL 400 WB F V2 HCMC

  • Multiple-type clinical chemistry analyte profile IVD, control
VOLATILES
UTAK LABORATORIES, INC.
VOL 2 WB F OCMEO
In Commercial Distribution

  • B800VOL2WBFOCMEO5 ()
  • B800VOL2WBFOCMEO0 ()

  • Total Volume: 50 Milliliter
VOL 2 WB F OCMEO

  • Multiple-type clinical chemistry analyte profile IVD, control
VOLATILES LEVEL 2
UTAK LABORATORIES, INC.
VOL 2 V2 S F RIH
In Commercial Distribution

  • B800VOL2V2SFRIH5 ()
  • B800VOL2V2SFRIH0 ()

  • Total Volume: 5 Milliliter
VOL 2 V2 S F RIH

  • Multiple drugs of abuse IVD, control
VOLATILES
UTAK LABORATORIES, INC.
VOL 1 WB F OCMEO
In Commercial Distribution

  • B800VOL1WBFOCMEO5 ()
  • B800VOL1WBFOCMEO0 ()

  • Total Volume: 50 Milliliter
VOL 1 WB F OCMEO

  • Multiple-type clinical chemistry analyte profile IVD, control
VITAMINS LEVEL 3
UTAK LABORATORIES, INC.
VIT 3 S F ECLI
In Commercial Distribution

  • B800VIT3SFECLI5 ()
  • B800VIT3SFECLI0 ()

  • Total Volume: 5 Milliliter
VIT 3 S F ECLI

  • Multiple-type clinical chemistry analyte profile IVD, control
VITAMINS LEVEL 2
UTAK LABORATORIES, INC.
VIT 2 S F ECLI
In Commercial Distribution

  • B800VIT2SFECLI5 ()
  • B800VIT2SFECLI0 ()

  • Total Volume: 5 Milliliter
VIT 2 S F ECLI

  • Multiple-type clinical chemistry analyte profile IVD, control
VITAMINS LEVEL 1
UTAK LABORATORIES, INC.
VIT 1 S F ECLI
In Commercial Distribution

  • B800VIT1SFECLI5 ()
  • B800VIT1SFECLI0 ()

  • Total Volume: 5 Milliliter
VIT 1 S F ECLI

  • Multiple-type clinical chemistry analyte profile IVD, control
PREGNENOLONE CONTROL
UTAK LABORATORIES, INC.
UTAK-SC PREG S F SD
In Commercial Distribution

  • B800UTAKSCPREGSFSD5 ()
  • B800UTAKSCPREGSFSD0 ()

  • Total Volume: 2 Milliliter
UTAK-SC PREG S F SD

  • Multiple-type clinical chemistry analyte profile IVD, control
METALS QC 3
UTAK LABORATORIES, INC.
UTAK-SC MET QC 3 S F SD
In Commercial Distribution

  • B800UTAKSCMETQC3SFSD5 ()
  • B800UTAKSCMETQC3SFSD0 ()

  • Total Volume: 5 Milliliter
UTAK-SC MET QC 3 S F SD

  • Multiple-type clinical chemistry analyte profile IVD, control
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