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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BUSULFAN 1000 NG/ML
UTAK LABORATORIES, INC.
BUS 1000 V P F CHLA
In Commercial Distribution

  • B800BUS1000VPFCHLA5 ()
  • B800BUS1000VPFCHLA0 ()
  • B800BUS1000VPFCHLA55 ()

  • Total Volume: 5 Milliliter
BUS 1000 V P F CHLA

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

  • B800BUPQC2UTRL5 ()
  • B800BUPQC2UTRL0 ()

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

  • Multiple-type clinical chemistry analyte profile IVD, control
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 MID
UTAK LABORATORIES, INC.
BUP+ M SMXU F PATH
In Commercial Distribution

  • B800BUPMSMXUFPATH5 ()
  • B800BUPMSMXUFPATH0 ()

  • Total Volume: 2 Milliliter
BUP+ M SMXU F PATH

  • Multiple-type clinical chemistry analyte profile IVD, control
BUPRENORPHINE PLUS LOW
UTAK LABORATORIES, INC.
BUP+ L SMXU F PATH
In Commercial Distribution

  • B800BUPLSMXUFPATH5 ()
  • B800BUPLSMXUFPATH0 ()

  • Total Volume: 2 Milliliter
BUP+ L SMXU F PATH

  • 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 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 V2
UTAK LABORATORIES, INC.
BENZO L2 V2 U F UW
In Commercial Distribution

  • B800BENZOL2V2UFUW5 ()
  • B800BENZOL2V2UFUW0 ()

  • Total Volume: 1 Milliliter
BENZO L2 V2 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 V3
UTAK LABORATORIES, INC.
BENZO L1 V3 U F UW
In Commercial Distribution

  • B800BENZOL1V3UFUW5 ()
  • B800BENZOL1V3UFUW0 ()

  • Total Volume: 0.75 Milliliter
BENZO L1 V3 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
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 HIGH
UTAK LABORATORIES, INC.
BARBS+ H S F LC
In Commercial Distribution

  • B800BARBSHSFLC5 ()
  • B800BARBSHSFLC0 ()

  • Total Volume: 1 Milliliter
BARBS+ H 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
BARBITURATES PLUS LEVEL 1
UTAK LABORATORIES, INC.
BARBS+ 1 U V F RDL
In Commercial Distribution

  • B800BARBS1UVFRDL5 ()
  • B800BARBS1UVFRDL0 ()

  • Total Volume: 3 Milliliter
BARBS+ 1 U V F RDL

  • Multiple-type clinical chemistry analyte profile IVD, control
BARBITURATES QC
UTAK LABORATORIES, INC.
BARB+ QC M LB
In Commercial Distribution

  • B800BARBQCMLB5 ()
  • B800BARBQCMLB0 ()

  • Total Volume: 0.5 Milliliter
BARB+ QC M LB

  • Multiple-type clinical chemistry analyte profile IVD, control
BARBCALV2MLB
UTAK LABORATORIES, INC.
BARB+ CAL V2 M LB
In Commercial Distribution

  • B800BARBCALV2MLB0 ()

  • Total Volume: 0.5 Milliliter
BARB+ CAL V2 M LB

  • Multiple-type clinical chemistry analyte profile IVD, control
BARBITURATES PLUS CALIBRATOR
UTAK LABORATORIES, INC.
BARB+ CAL M F ACL
In Commercial Distribution

  • B800BARBCALMFACL5 ()
  • B800BARBCALMFACL0 ()

  • Total Volume: 3 Milliliter
BARB+ CAL M F ACL

  • Multiple-type clinical chemistry analyte profile IVD, control
BARBITURATES PLUS LEVEL 2
UTAK LABORATORIES, INC.
BARB+ 2 M F ACL
In Commercial Distribution

  • B800BARB2MFACL5 ()
  • B800BARB2MFACL0 ()

  • Total Volume: 3 Milliliter
BARB+ 2 M F ACL

  • Multiple-type clinical chemistry analyte profile IVD, control
BARBITURATES PLUS LEVEL 1
UTAK LABORATORIES, INC.
BARB+ 1 M F ACL
In Commercial Distribution

  • B800BARB1MFACL5 ()
  • B800BARB1MFACL0 ()

  • Total Volume: 3 Milliliter
BARB+ 1 M F ACL

  • Multiple-type clinical chemistry analyte profile IVD, control
ARSENIC PLUS LEVEL 3 V3
UTAK LABORATORIES, INC.
ARSEN+ 3 V3 U F LC
In Commercial Distribution

  • B800ARSEN3V3UFLC5 ()
  • B800ARSEN3V3UFLC0 ()

  • Total Volume: 0.2 Milliliter
ARSEN+ 3 V3 U F LC

  • 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
ANTIFUNGAL QC LEVEL 2
UTAK LABORATORIES, INC.
ANTIF QC 2 V2 LP F TF
In Commercial Distribution

  • B800ANTIFQC2V2LPFTF5 ()
  • B800ANTIFQC2V2LPFTF0 ()

  • Total Volume: 1 Milliliter
ANTIF QC 2 V2 LP F TF

  • Multiple-therapy therapeutic drug monitoring IVD, control
ANTIFUNGAL QC LEVEL 1
UTAK LABORATORIES, INC.
ANTIF QC 1 V2 LP F TF
In Commercial Distribution

  • B800ANTIFQC1V2LPFTF5 ()
  • B800ANTIFQC1V2LPFTF0 ()

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

  • Multiple-therapy therapeutic drug monitoring IVD, control
ANTIFUNGALS LEVEL 3 V3
UTAK LABORATORIES, INC.
ANTIF 3 V3 F UVHS
In Commercial Distribution

  • B800ANTIF3V3FUVHS5 ()
  • B800ANTIF3V3FUVHS0 ()

  • Total Volume: 10 Milliliter
ANTIF 3 V3 F UVHS

  • Multiple-type clinical chemistry analyte profile IVD, control
ANTIFUNGALS LEVEL 3 V2
UTAK LABORATORIES, INC.
ANTIF 3 V2 F UVHS
In Commercial Distribution

  • B800ANTIF3V2FUVHS5 ()
  • B800ANTIF3V2FUVHS0 ()

  • Total Volume: 10 Milliliter
ANTIF 3 V2 F UVHS

  • Multiple-therapy therapeutic drug monitoring IVD, control
ANTIFUNGALS LEVEL 2 V2
UTAK LABORATORIES, INC.
ANTIF 2 V2 F UVHS
In Commercial Distribution

  • B800ANTIF2V2FUVHS5 ()
  • B800ANTIF2V2FUVHS0 ()

  • Total Volume: 10 Milliliter
ANTIF 2 V2 F UVHS

  • Multiple-therapy therapeutic drug monitoring IVD, control
ANTIFUNGALS LEVEL 1 V2
UTAK LABORATORIES, INC.
ANTIF 1 V2 F UVHS
In Commercial Distribution

  • B800ANTIF1V2FUVHS5 ()
  • B800ANTIF1V2FUVHS0 ()

  • Total Volume: 10 Milliliter
ANTIF 1 V2 F UVHS

  • Multiple-therapy therapeutic drug monitoring IVD, control
ANTID LEVEL 2
UTAK LABORATORIES, INC.
ANTID 2 MAYO
In Commercial Distribution

  • B800ANTID2MAYO5 ()
  • B800ANTID2MAYO0 ()

  • Total Volume: 0.75 Milliliter
ANTID 2 MAYO

  • Multiple-type clinical chemistry analyte profile IVD, control
ANTIBLKSFUNC
UTAK LABORATORIES, INC.
ANTI BLK S F UNC
In Commercial Distribution

  • B800ANTIBLKSFUNC5 ()
  • B800ANTIBLKSFUNC0 ()

  • Total Volume: 2 Milliliter
ANTI BLK S F UNC

  • Multiple-type clinical chemistry analyte profile IVD, control
ANTIFUNGALS CALIBRATOR 6
UTAK LABORATORIES, INC.
ANTI 6 S F UNC
In Commercial Distribution

  • B800ANTI6SFUNC5 ()
  • B800ANTI6SFUNC0 ()

  • Total Volume: 2 Milliliter
ANTI 6 S F UNC

  • Multiple-type clinical chemistry analyte profile IVD, control
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