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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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ALDOSTERONE LEVEL 2
UTAK LABORATORIES, INC.
ALD 2 U F LC
In Commercial Distribution

  • B800ALD2UFLC5 ()
  • B800ALD2UFLC0 ()

  • Total Volume: 5 Milliliter
ALD 2 U F LC

  • Multiple-type clinical chemistry analyte profile IVD, control
ANTIFUNGALS LEVEL 3
UTAK LABORATORIES, INC.
A-FUNG L3 S F UW
In Commercial Distribution

  • B800AFUNGL3SFUW5 ()
  • B800AFUNGL3SFUW0 ()

  • Total Volume: 2 Milliliter
A-FUNG L3 S F UW

  • Multiple drugs of abuse IVD, control
ANTIFUNGALS LEVEL 3
UTAK LABORATORIES, INC.
A-FUNG L3 S F MAYO
In Commercial Distribution

  • B800AFUNGL3SFMAYO5 ()
  • B800AFUNGL3SFMAYO0 ()

  • Total Volume: 0.5 Milliliter
A-FUNG L3 S F MAYO

  • Multiple drugs of abuse IVD, control
ANTIFUNGALS LEVEL 2
UTAK LABORATORIES, INC.
A-FUNG L2 S F UW
In Commercial Distribution

  • B800AFUNGL2SFUW5 ()
  • B800AFUNGL2SFUW0 ()

  • Total Volume: 2 Milliliter
A-FUNG L2 S F UW

  • Multiple drugs of abuse IVD, control
ANTIFUNGALS LEVEL 2
UTAK LABORATORIES, INC.
A-FUNG L2 S F MAYO
In Commercial Distribution

  • B800AFUNGL2SFMAYO5 ()
  • B800AFUNGL2SFMAYO0 ()

  • Total Volume: 0.5 Milliliter
A-FUNG L2 S F MAYO

  • Multiple-therapy therapeutic drug monitoring IVD, control
CERTIFIED DRUG FREE URINE
UTAK LABORATORIES, INC.
88121-CDF(F)10 NJSP
In Commercial Distribution

  • B80088121CDFF10NJSP5 ()
  • B80088121CDFF10NJSP0 ()

  • Total Volume: 10 Milliliter
88121-CDF(F)10 NJSP

  • Multiple-type clinical chemistry analyte profile IVD, control
CERTIFIED DRUG FREE URINE
UTAK LABORATORIES, INC.
88121-CDF(F)10 FS
In Commercial Distribution

  • B80088121CDFF10FS5 ()
  • B80088121CDFF10FS0 ()

  • Total Volume: 10 Milliliter
88121-CDF(F)10 FS

  • Multiple-type clinical chemistry analyte profile IVD, control
CERTIFIED DRUG FREE URINE 100ML
UTAK LABORATORIES, INC.
88121-CDF(F)100 PDH
In Commercial Distribution

  • B80088121CDFF100PDH5 ()
  • B80088121CDFF100PDH0 ()

  • Total Volume: 100 Milliliter
88121-CDF(F)100 PDH

  • Multiple-type clinical chemistry analyte profile IVD, control
CERTIFIED DRUG FREE URINE
UTAK LABORATORIES, INC.
88121-CDF(F)100
In Commercial Distribution

  • B80088121CDFF1005 ()
  • B80088121CDFF1000 ()

  • Total Volume: 100 Milliliter
88121-CDF(F)100

  • Multiple-type clinical chemistry analyte profile IVD, control
Certified Drug Free Urine (Frozen)
UTAK LABORATORIES, INC.
88121-CDF(F)
In Commercial Distribution

  • B8008812110 ()

  • Total Volume: 835 Milliliter
88121-CDF(F)

  • Multiple therapeutic drugs/drugs of abuse IVD, control
BLANK WHOLE BLOOD 100 ML
UTAK LABORATORIES, INC.
44600-WB(F) 100
In Commercial Distribution

  • B80044600WBF1005 ()
  • B80044600WBF1000 ()

  • Total Volume: 100 Milliliter
44600-WB(F) 100

  • Multiple-type clinical chemistry analyte profile IVD, control
DEFIBRINATED PLASMA
UTAK LABORATORIES, INC.
44600-DAL10
In Commercial Distribution

  • B80044600DAL105 ()
  • B80044600DAL100 ()

  • Total Volume: 10 Milliliter
44600-DAL10

  • Multiple-type clinical chemistry analyte profile IVD, control
DEFIBRINATED PLASMA
UTAK LABORATORIES, INC.
44600-D(5
In Commercial Distribution

  • B80044600D55 ()
  • B80044600D50 ()

  • Total Volume: 5 Milliliter
44600-D(5

  • Multiple-type clinical chemistry analyte profile IVD, control
Blank Whole Blood (Frozen)
UTAK LABORATORIES, INC.
44600-WB(F)
In Commercial Distribution

  • B8004460030 ()

  • Total Volume: 250 Milliliter
44600-WB(F)

  • Multiple therapeutic drugs/drugs of abuse IVD, control
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
Defibrinated Plasma (Frozen)
UTAK LABORATORIES, INC.
44600-D(500)
In Commercial Distribution

  • B8004460010 ()

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

  • Multiple therapeutic drugs/drugs of abuse IVD, control
DOA Cutoff (OF)
UTAK LABORATORIES, INC.
43052
In Commercial Distribution

  • B800430525 ()
  • B800430520 ()

  • Total Volume: 3 Milliliter
43052

  • Multiple drugs of abuse IVD, control
DOA Cutoff (OF) Frozen
UTAK LABORATORIES, INC.
43051
In Commercial Distribution

  • B800430515 ()
  • B800430510 ()

  • Total Volume: 3 Milliliter
43051

  • Multiple drugs of abuse IVD, control
DOA 50% Cutoff
UTAK LABORATORIES, INC.
43050
In Commercial Distribution

  • B800430505 ()
  • B800430500 ()

  • Total Volume: 3 Milliliter
43050

  • Multiple drugs of abuse IVD, control
DEXAMETHASONE LEVEL 3
UTAK LABORATORIES, INC.
20199
In Commercial Distribution

  • B800201995 ()
  • B800201990 ()

  • Total Volume: 3 Milliliter
20199

  • Multiple steroid 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
DEXAMETHASONE LEVEL 1
UTAK LABORATORIES, INC.
20197
In Commercial Distribution

  • B800201972 ()
  • B800201970 ()

  • Total Volume: 3 Milliliter
20197

  • Multiple steroid hormone 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
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
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