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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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BUPRENORPHINE PLUS QC LEVEL 1
UTAK LABORATORIES, INC.
BUP+ QC 1 U TRL
In Commercial Distribution

  • B800BUPQC1UTRL5 ()
  • B800BUPQC1UTRL0 ()

  • Total Volume: 2 Milliliter
BUP+ QC 1 U TRL

  • Multiple-type clinical chemistry analyte profile IVD, control
BUPRENORPHINE PLUS LEVEL 2
UTAK LABORATORIES, INC.
BUP+ 2 U F FML
In Commercial Distribution

  • B800BUP2UFFML5 ()
  • B800BUP2UFFML0 ()

  • Total Volume: 1 Milliliter
BUP+ 2 U F FML

  • Multiple drugs of abuse IVD, control
BUPRENORPHINE PLUS LEVEL 1 V2
UTAK LABORATORIES, INC.
BUP+ 1 V2 U F MAYO
In Commercial Distribution

  • B800BUP1V2UFMAYO5 ()
  • B800BUP1V2UFMAYO0 ()

  • Total Volume: 1 Milliliter
BUP+ 1 V2 U F MAYO

  • Multiple-type clinical chemistry analyte profile IVD, control
BUPRENORPHINE PLUS LEVEL 1
UTAK LABORATORIES, INC.
BUP+ 1 U KP
In Commercial Distribution

  • B800BUP1UKP5 ()
  • B800BUP1UKP0 ()

  • Total Volume: 1 Milliliter
BUP+ 1 U KP

  • Multiple therapeutic drugs/drugs of abuse IVD, control
BUPRENORPHINE PLUS LEVEL 1
UTAK LABORATORIES, INC.
BUP+ 1 U F FML
In Commercial Distribution

  • B800BUP1UFFML5 ()
  • B800BUP1UFFML0 ()

  • Total Volume: 1 Milliliter
BUP+ 1 U F FML

  • Multiple drugs of abuse IVD, control
BSIM QC
UTAK LABORATORIES, INC.
BSIM QC
In Commercial Distribution

  • B800BSIMQC5 ()
  • B800BSIMQC0 ()

  • Total Volume: 25 Milliliter
BSIM QC

  • Multiple-type clinical chemistry analyte profile IVD, control
BLANK WHOLE BLOOD
UTAK LABORATORIES, INC.
BLK WB NC
In Commercial Distribution

  • B800BLKWBNC5 ()
  • B800BLKWBNC0 ()

  • Total Volume: 2 Milliliter
BLK WB NC

  • Multiple-type clinical chemistry analyte profile IVD, control
CERTIFIED DRUG FREE URINE
UTAK LABORATORIES, INC.
BLK U F 100 MAKO
In Commercial Distribution

  • B800BLKUF100MAKO5 ()
  • B800BLKUF100MAKO0 ()

  • Total Volume: 10 Milliliter
BLK U F 100 MAKO

  • Multiple-type clinical chemistry analyte profile IVD, control
BLANK HAIR MATRIX
UTAK LABORATORIES, INC.
BLK HAIR OL
In Commercial Distribution

  • B800BLKHAIROL0 ()
  • B800BLKHAIROL5 ()

  • Total Volume: 100 Milliliter
BLK HAIR OL

  • Multiple therapeutic drugs/drugs of abuse IVD, control
BENZU UNCOMMON PATH QC 2
UTAK LABORATORIES, INC.
BENZU NCP PATH QC 2 V3
In Commercial Distribution

  • B800BENZUNCPPATHQC2V30 ()
  • B800BENZUNCPPATHQC2V35 ()

  • Total Volume: 1.2 Milliliter
BENZU NCP PATH QC 2 V3

  • Multiple-type clinical chemistry analyte profile IVD, control
BENZODIAZEPINES
UTAK LABORATORIES, INC.
BENZ U F KP
In Commercial Distribution

  • B800BENZUFKP5 ()
  • B800BENZUFKP0 ()

  • Total Volume: 20 Milliliter
BENZ U F KP

  • Multiple-type clinical chemistry analyte profile IVD, control
No Description
UTAK LABORATORIES, INC.
BENZU CP QC 2 V3
In Commercial Distribution

  • B800BENZUCPQC2V35 ()
  • B800BENZUCPQC2V30 ()

  • Total Volume: 1.2 Milliliter
BENZU CP QC 2 V3

  • Multiple-type clinical chemistry analyte profile IVD, control
BENZOYLECGONINE LEVEL 2
UTAK LABORATORIES, INC.
BENZOYL 2 F APTC
In Commercial Distribution

  • B800BENZOYL2FAPTC5 ()
  • B800BENZOYL2FAPTC0 ()

  • Total Volume: 10 Milliliter
BENZOYL 2 F APTC

  • Multiple drugs of abuse IVD, control
BENZOYLECGONINE LEVEL 1
UTAK LABORATORIES, INC.
BENZOYL 1 F APTC
In Commercial Distribution

  • B800BENZOYL1FAPTC5 ()
  • B800BENZOYL1FAPTC0 ()

  • Total Volume: 10 Milliliter
BENZOYL 1 F APTC

  • Multiple drugs of abuse IVD, control
BENZOYLECGONINE 700 NG/ML
UTAK LABORATORIES, INC.
BENZOY 700 U F APS
In Commercial Distribution

  • B800BENZOY700UFAPS5 ()
  • B800BENZOY700UFAPS0 ()

  • Total Volume: 1 Milliliter
BENZOY 700 U F APS

  • Multiple drugs of abuse IVD, control
BENZODIAZEPINES PLUS
UTAK LABORATORIES, INC.
BENZO+ U F TRL
In Commercial Distribution

  • B800BENZOUFTRL5 ()
  • B800BENZOUFTRL0 ()

  • Total Volume: 1 Milliliter
BENZO+ U F TRL

  • Multiple-type clinical chemistry analyte profile IVD, control
BENZODIAZEPINES QC V4
UTAK LABORATORIES, INC.
BENZO QC V4 FCCO
In Commercial Distribution

  • B800BENZOQCV4FCCO5 ()
  • B800BENZOQCV4FCCO0 ()

  • Total Volume: 25 Milliliter
BENZO QC V4 FCCO

  • Multiple-type clinical chemistry analyte profile IVD, control
BENZODIAZEPINES LEVEL 2 V3
UTAK LABORATORIES, INC.
BENZO L2 V3 U F UW
In Commercial Distribution

  • B800BENZOL2V3UFUW5 ()
  • B800BENZOL2V3UFUW0 ()

  • Total Volume: 0.75 Milliliter
BENZO L2 V3 U F UW

  • Multiple-type clinical chemistry analyte profile IVD, control
BENZODIAZEPINES LEVEL 2
UTAK LABORATORIES, INC.
BENZO L2 U F UW
In Commercial Distribution

  • B800BENZOL2UFUW5 ()
  • B800BENZOL2UFUW0 ()

  • Total Volume: 1 Milliliter
BENZO L2 U F UW

  • Multiple-type clinical chemistry analyte profile IVD, control
BENZODIAZEPINES LEVEL 1 V2
UTAK LABORATORIES, INC.
BENZO L1 V2 U F UW
In Commercial Distribution

  • B800BENZOL1V2UFUW5 ()
  • B800BENZOL1V2UFUW0 ()

  • Total Volume: 1 Milliliter
BENZO L1 V2 U F UW

  • Multiple-type clinical chemistry analyte profile IVD, control
BENZODIAZEPINES LEVEL 1
UTAK LABORATORIES, INC.
BENZO L1 U F UW
In Commercial Distribution

  • B800BENZOL1UFUW0 ()

  • Total Volume: 1 Milliliter
BENZO L1 U F UW

  • Multiple-type clinical chemistry analyte profile IVD, control
BENZODIAZEPINES 150 NG/ML
UTAK LABORATORIES, INC.
BENZO 150 U F QDPA
In Commercial Distribution

  • B800BENZO150UFQDPA5 ()
  • B800BENZO150UFQDPA0 ()

  • Total Volume: 1 Milliliter
BENZO 150 U F QDPA

  • Multiple-type clinical chemistry analyte profile IVD, control
BASIC QC
UTAK LABORATORIES, INC.
BASIC QC
In Commercial Distribution

  • B800BASICQC5 ()
  • B800BASICQC0 ()

  • Total Volume: 25 Milliliter
BASIC QC

  • Multiple-type clinical chemistry analyte profile IVD, control
BARBITURATES PLUS MID
UTAK LABORATORIES, INC.
BARBS+ M S F LC
In Commercial Distribution

  • B800BARBSMSFLC5 ()
  • B800BARBSMSFLC0 ()

  • Total Volume: 1 Milliliter
BARBS+ M S F LC

  • Multiple-type clinical chemistry analyte profile IVD, control
BARBITURATES PLUS LOW
UTAK LABORATORIES, INC.
BARBS+ L S F LC
In Commercial Distribution

  • B800BARBSLSFLC5 ()
  • B800BARBSLSFLC0 ()

  • Total Volume: 1 Milliliter
BARBS+ L S F LC

  • Multiple-type clinical chemistry analyte profile IVD, control
BARBITURATES PLUS LEVEL 2
UTAK LABORATORIES, INC.
BARBS+ 2 U V F RDL
In Commercial Distribution

  • B800BARBS2UVFRDL5 ()
  • B800BARBS2UVFRDL0 ()

  • Total Volume: 3 Milliliter
BARBS+ 2 U V F RDL

  • Multiple-type clinical chemistry analyte profile IVD, control
ARSENIC PLUS LEVEL 3
UTAK LABORATORIES, INC.
ARSEN+ 3 V2 U F LC
In Commercial Distribution

  • B800ARSEN3V2UFLC5 ()
  • B800ARSEN3V2UFLC0 ()

  • Total Volume: 2 Milliliter
ARSEN+ 3 V2 U F LC

  • Multiple-type clinical chemistry analyte profile IVD, control
ARSENIC PLUS LEVEL 3
UTAK LABORATORIES, INC.
ARSEN+ 3 U F LC
In Commercial Distribution

  • B800ARSEN3UFLC5 ()
  • B800ARSEN3UFLC0 ()

  • Total Volume: 2 Milliliter
ARSEN+ 3 U F LC

  • Multiple-type clinical chemistry analyte profile IVD, control
ARSENIC PLUS LEVEL 2 V3
UTAK LABORATORIES, INC.
ARSEN+ 2 V3 U F LC
In Commercial Distribution

  • B800ARSEN2V3UFLC5 ()
  • B800ARSEN2V3UFLC0 ()

  • Total Volume: 0.2 Milliliter
ARSEN+ 2 V3 U F LC

  • Multiple-type clinical chemistry analyte profile IVD, control
ARSENIC PLUS LEVEL 2
UTAK LABORATORIES, INC.
ARSEN+ 2 V2 U F LC
In Commercial Distribution

  • B800ARSEN2V2UFLC5 ()
  • B800ARSEN2V2UFLC0 ()

  • Total Volume: 2 Milliliter
ARSEN+ 2 V2 U F LC

  • Multiple-type clinical chemistry analyte profile IVD, control
ARSENIC PLUS LEVEL 2
UTAK LABORATORIES, INC.
ARSEN+ 2 U F LC
In Commercial Distribution

  • B800ARSEN2UFLC5 ()
  • B800ARSEN2UFLC0 ()

  • Total Volume: 2 Milliliter
ARSEN+ 2 U F LC

  • Multiple-type clinical chemistry analyte profile IVD, control
ARSENIC PLUS LEVEL 1 V3
UTAK LABORATORIES, INC.
ARSEN+ 1 V3 U F LC
In Commercial Distribution

  • B800ARSEN1V3UFLC5 ()
  • B800ARSEN1V3UFLC0 ()

  • Total Volume: 0.2 Milliliter
ARSEN+ 1 V3 U F LC

  • Multiple-type clinical chemistry analyte profile IVD, control
ARSENIC PLUS LEVEL 1
UTAK LABORATORIES, INC.
ARSEN+ 1 V2 U F LC
In Commercial Distribution

  • B800ARSEN1V2UFLC5 ()
  • B800ARSEN1V2UFLC0 ()

  • Total Volume: 2 Milliliter
ARSEN+ 1 V2 U F LC

  • Multiple-type clinical chemistry analyte profile IVD, control
ARSENIC PLUS LEVEL 1
UTAK LABORATORIES, INC.
ARSEN+ 1 U F LC
In Commercial Distribution

  • B800ARSEN1UFLC5 ()
  • B800ARSEN1UFLC0 ()

  • Total Volume: 2 Milliliter
ARSEN+ 1 U F LC

  • Multiple-type clinical chemistry analyte profile IVD, control
ORAL FLUID UTAK
UTAK LABORATORIES, INC.
ANTIPSYCH+ V4 OF F OT
In Commercial Distribution

  • B800ANTIPSYCHV4OFFOT5 ()
  • B800ANTIPSYCHV4OFFOT0 ()

  • Total Volume: 1 Milliliter
ANTIPSYCH+ V4 OF F OT

  • Multiple-type clinical chemistry analyte profile IVD, control
ANTIPSYCHOTICS URINE PLUS V3
UTAK LABORATORIES, INC.
ANTIPSYCH+ V3 U F ODX
In Commercial Distribution

  • B800ANTIPSYCHV3UFODX5 ()
  • B800ANTIPSYCHV3UFODX0 ()

  • Total Volume: 1 Milliliter
ANTIPSYCH+ V3 U F ODX

  • Multiple-type clinical chemistry analyte profile IVD, control
ANTIPSYCH+ V3 OF F OT
UTAK LABORATORIES, INC.
ORAL FLUID UTAK
In Commercial Distribution

  • B800ANTIPSYCHV3OFFOT5 ()
  • B800ANTIPSYCHV3OFFOT0 ()

  • Total Volume: 1 Milliliter
ORAL FLUID UTAK

  • Multiple-type clinical chemistry analyte profile IVD, control
ANTIPSYCHOTICS URINE PLUS
UTAK LABORATORIES, INC.
ANTIPSYCH+ V2 U F OT
In Commercial Distribution

  • B800ANTIPSYCHV2UFOT5 ()
  • B800ANTIPSYCHV2UFOT0 ()

  • Total Volume: 1 Milliliter
ANTIPSYCH+ V2 U F OT

  • Multiple-type clinical chemistry analyte profile IVD, control
ANTIHISTAMINES PLUS
UTAK LABORATORIES, INC.
ANTIHIST+ S F NMS
In Commercial Distribution

  • B800ANTIHISTSFNMS5 ()
  • B800ANTIHISTSFNMS0 ()

  • Total Volume: 5 Milliliter
ANTIHIST+ S F NMS

  • Multiple-type clinical chemistry analyte profile IVD, control
ANTIFUNGAL QC LEVEL 3
UTAK LABORATORIES, INC.
ANTIF QC 3 V2 LP F TF
In Commercial Distribution

  • B800ANTIFQC3V2LPFTF5 ()
  • B800ANTIFQC3V2LPFTF0 ()

  • Total Volume: 1 Milliliter
ANTIF QC 3 V2 LP F TF

  • Multiple-therapy therapeutic drug monitoring IVD, control
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