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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CHANG Medium D with L-Glutamine. 500mL bottle.
IRVINE SCIENTIFIC, LLC
T105-500ML
In Commercial Distribution

  • 00810195240637 ()
T105

  • Cell culture medium IVD
CHANG Medium D with L-Glutamine. 100mL bottle.
IRVINE SCIENTIFIC, LLC
T105-100ML
In Commercial Distribution

  • 00810195240620 ()
T105

  • Cell culture medium IVD
CHANG Medium C Frozen Supplement (14mL)
IRVINE SCIENTIFIC, LLC
C106-14ML
In Commercial Distribution

  • 00810195240613 ()
C106

  • Cell culture medium IVD
CHANG Amnio with Gentamicin and L-Glutamine. 100mL bottle.
IRVINE SCIENTIFIC, LLC
99473-100ML
In Commercial Distribution

  • 00810195240590 ()
99473

  • Cell culture medium IVD
CHANG Medium D with Gentamicin for Human Amniotic Fluid Cells. 100mL bottle.
IRVINE SCIENTIFIC, LLC
99404-100ML
In Commercial Distribution

  • 00810195240583 ()
99404

  • Cell culture medium IVD
Freezing Medium Test Yolk Buffer (TYB) with Glycerol and Gentamicin
IRVINE SCIENTIFIC, LLC
90128-20x5ML
In Commercial Distribution

  • 00810195240163 ()
90128

  • IVF medium
Refrigeration Medium - Test Yolk Buffer (TYB) with Gentamicin
IRVINE SCIENTIFIC, LLC
90129-20x5ML
In Commercial Distribution

  • 00810195240156 ()
90129

  • IVF medium
DRUGS OF ABUSE QC HIGH
UTAK LABORATORIES, INC.
DA QC HIGH U F UMHC
In Commercial Distribution

  • B800DAQCHIGHUFUMHC5 ()
  • B800DAQCHIGHUFUMHC0 ()

  • Total Volume: 20 Milliliter
DA QC HIGH U F UMHC

  • Multiple-type clinical chemistry analyte profile IVD, control
DRUGS OF ABUSE POSITIVE
UTAK LABORATORIES, INC.
DA POS V2 WB F KBI
In Commercial Distribution

  • B800DAPOSV2WBFKBI5 ()
  • B800DAPOSV2WBFKBI0 ()

  • Total Volume: 3 Milliliter
DA POS V2 WB F KBI

  • Multiple drugs of abuse IVD, control
DRUGS OF ABUSE POSITIVE
UTAK LABORATORIES, INC.
DA POS BM F MMB
In Commercial Distribution

  • B800DAPOSBMFMMB5 ()
  • B800DAPOSBMFMMB0 ()

  • Total Volume: 5 Milliliter
DA POS BM F MMB

  • Multiple drugs of abuse IVD, control
DRUGS OF ABUSE LEVEL 2
UTAK LABORATORIES, INC.
DA OF 2 F PM
In Commercial Distribution

  • B800DAOF2FPM5 ()
  • B800DAOF2FPM0 ()

  • Total Volume: 3 Milliliter
DA OF 2 F PM

  • Multiple drugs of abuse IVD, control
DRUGS OF ABUSE LEVEL 2
UTAK LABORATORIES, INC.
DA OF 2 F ADX
In Commercial Distribution

  • B800DAOF2FADX5 ()
  • B800DAOF2FADX0 ()

  • Total Volume: 3 Milliliter
DA OF 2 F ADX

  • Multiple drugs of abuse IVD, control
DRUGS OF ABUSE LEVEL 1
UTAK LABORATORIES, INC.
DA OF 1 F PM
In Commercial Distribution

  • B800DAOF1FPM5 ()
  • B800DAOF1FPM0 ()

  • Total Volume: 3 Milliliter
DA OF 1 F PM

  • Multiple drugs of abuse IVD, control
DRUGS OF ABUSE LEVEL 1
UTAK LABORATORIES, INC.
DA OF 1 F ADX
In Commercial Distribution

  • B800DAOF1FADX5 ()
  • B800DAOF1FADX0 ()

  • Total Volume: 3 Milliliter
DA OF 1 F ADX

  • Multiple drugs of abuse IVD, control
DRUGS OF ABUSE NEGATIVE
UTAK LABORATORIES, INC.
DA NEG BM F MMB
In Commercial Distribution

  • B800DANEGBMFMMB5 ()
  • B800DANEGBMFMMB0 ()

  • Total Volume: 5 Milliliter
DA NEG BM F MMB

  • Multiple drugs of abuse IVD, control
DRUGS OF ABUSE
UTAK LABORATORIES, INC.
DA M F PL V2
In Commercial Distribution

  • B800DAMFPLV25 ()
  • B800DAMFPLV20 ()

  • Total Volume: 5 Milliliter
DA M F PL V2

  • Multiple-type clinical chemistry analyte profile IVD, control
CARBAMAZEPINE-10,11-EPOXIDE LEVEL 3
UTAK LABORATORIES, INC.
C1011 L3 V4
In Commercial Distribution

  • B800C1011L3V45 ()
  • B800C1011L3V40 ()

  • Total Volume: 0.5 Milliliter
C1011 L3 V4

  • Multiple drugs of abuse IVD, control
CARBAMAZEPINE-10,11-EPOXIDE LEVEL 3
UTAK LABORATORIES, INC.
C1011 L3 V3
In Commercial Distribution

  • B800C1011L3V35 ()
  • B800C1011L3V30 ()

  • Total Volume: 0.5 Milliliter
C1011 L3 V3

  • Multiple therapeutic drugs/drugs of abuse IVD, control
CARBAMAZEPINE-10,11-EPOXIDE LEVEL 2
UTAK LABORATORIES, INC.
C1011 L2 V4
In Commercial Distribution

  • B800C1011L2V45 ()
  • B800C1011L2V40 ()

  • Total Volume: 0.5 Milliliter
C1011 L2 V4

  • Multiple drugs of abuse IVD, control
CARBAMAZEPINE-10,11-EPOXIDE LEVEL 2
UTAK LABORATORIES, INC.
C1011 L2 V3
In Commercial Distribution

  • B800C1011L2V35 ()
  • B800C1011L2V30 ()

  • Total Volume: 0.5 Milliliter
C1011 L2 V3

  • Multiple therapeutic drugs/drugs of abuse IVD, control
CARBAMAZEPINE-10,11-EPOXIDE LEVEL 1
UTAK LABORATORIES, INC.
C1011 L1 V4
In Commercial Distribution

  • B800C1011L1V45 ()
  • B800C1011L1V40 ()

  • Total Volume: 0.5 Milliliter
C1011 L1 V4

  • Multiple drugs of abuse IVD, control
CARBAMAZEPINE-10,11-EPOXIDE LEVEL 1
UTAK LABORATORIES, INC.
C1011 L1 V3
In Commercial Distribution

  • B800C1011L1V35 ()
  • B800C1011L1V30 ()

  • Total Volume: 0.5 Milliliter
C1011 L1 V3

  • Multiple therapeutic drugs/drugs of abuse IVD, control
BUTALBITAL PLUS 3 V2
UTAK LABORATORIES, INC.
BUTALBITAL+ 3 V2 AP
In Commercial Distribution

  • B800BUTALBITAL3V2AP5 ()
  • B800BUTALBITAL3V2AP0 ()

  • Total Volume: 10 Milliliter
BUTALBITAL+ 3 V2 AP

  • Multiple-type clinical chemistry analyte profile IVD, control
BUTALBITAL PLUS 2 V2
UTAK LABORATORIES, INC.
BUTALBITAL+ 2 V2 AP
In Commercial Distribution

  • B800BUTALBITAL2V2AP5 ()
  • B800BUTALBITAL2V2AP0 ()

  • Total Volume: 10 Milliliter
BUTALBITAL+ 2 V2 AP

  • Multiple-type clinical chemistry analyte profile IVD, control
BUTALBITAL PLUS 1 V2
UTAK LABORATORIES, INC.
BUTALBITAL+ 1 V2 AP
In Commercial Distribution

  • B800BUTALBITAL1V2AP5 ()
  • B800BUTALBITAL1V2AP0 ()

  • Total Volume: 10 Milliliter
BUTALBITAL+ 1 V2 AP

  • Multiple-type clinical chemistry analyte profile IVD, control
BUSULFAN QC LEVEL 3
UTAK LABORATORIES, INC.
BUS QC 3 F SHP BHM
In Commercial Distribution

  • B800BUSQC3FSHPBHM5 ()
  • B800BUSQC3FSHPBHM0 ()

  • Total Volume: 2 Milliliter
BUS QC 3 F SHP BHM

  • Multiple-type clinical chemistry analyte profile IVD, control
BUSULFAN QC LEVEL 2
UTAK LABORATORIES, INC.
BUS QC 2 P F URMC
In Commercial Distribution

  • B800BUSQC2PFURMC5 ()
  • B800BUSQC2PFURMC0 ()

  • Total Volume: 5 Milliliter
BUS QC 2 P F URMC

  • Multiple-type clinical chemistry analyte profile IVD, control
BUSULFAN QC LEVEL 2
UTAK LABORATORIES, INC.
BUS QC 2 F SHP BHM
In Commercial Distribution

  • B800BUSQC2FSHPBHM5 ()
  • B800BUSQC2FSHPBHM0 ()

  • Total Volume: 2 Milliliter
BUS QC 2 F SHP BHM

  • Multiple-type clinical chemistry analyte profile IVD, control
BUSULFAN QC LEVEL 1
UTAK LABORATORIES, INC.
BUS QC 1 P F URMC
In Commercial Distribution

  • B800BUSQC1PFURMC5 ()
  • B800BUSQC1PFURMC0 ()

  • Total Volume: 5 Milliliter
BUS QC 1 P F URMC

  • Multiple-type clinical chemistry analyte profile IVD, control
BUSULFAN LEVEL 1
UTAK LABORATORIES, INC.
BUS QC 1 F CMH
In Commercial Distribution

  • B800BUSQC1FCMH5 ()
  • B800BUSQC1FCMH0 ()

  • Total Volume: 3 Milliliter
BUS QC 1 F CMH

  • Multiple-type clinical chemistry analyte profile IVD, control
BUSULFAN MID
UTAK LABORATORIES, INC.
BUS M SP F TCH
In Commercial Distribution

  • B800BUSMSPFTCH5 ()
  • B800BUSMSPFTCH0 ()

  • Total Volume: 5 Milliliter
BUS M SP F TCH

  • Multiple-therapy therapeutic drug monitoring IVD, control
BUSULFAN LOW
UTAK LABORATORIES, INC.
BUS L SP F TCH
In Commercial Distribution

  • B800BUSLSPFTCH5 ()
  • B800BUSLSPFTCH0 ()

  • Total Volume: 5 Milliliter
BUS L SP F TCH

  • Multiple-therapy therapeutic drug monitoring IVD, control
BUSULFAN HIGH
UTAK LABORATORIES, INC.
BUS H SP F TCH
In Commercial Distribution

  • B800BUSHSPFTCH5 ()
  • B800BUSHSPFTCH0 ()

  • Total Volume: 5 Milliliter
BUS H SP F TCH

  • Multiple-therapy therapeutic drug monitoring IVD, control
BUSULFAN CONTROL LEVEL 3
UTAK LABORATORIES, INC.
BUS CONT 3 SJCRH
In Commercial Distribution

  • B800BUSCONT3SJCRH5 ()
  • B800BUSCONT3SJCRH0 ()

  • Total Volume: 5 Milliliter
BUS CONT 3 SJCRH

  • Multiple drugs of abuse IVD, control
BUSULFAN CONTROL LEVEL 2
UTAK LABORATORIES, INC.
BUS CONT 2 SJCRH
In Commercial Distribution

  • B800BUSCONT2SJCRH0 ()

  • Total Volume: 5 Milliliter
BUS CONT 2 SJCRH

  • Multiple drugs of abuse IVD, control
BUSULFAN CALIBRATOR LEVEL 1
UTAK LABORATORIES, INC.
BUS CONT 1 SJCRH
In Commercial Distribution

  • B800BUSCONT1SJCRH5 ()
  • B800BUSCONT1SJCRH0 ()

  • Total Volume: 5 Milliliter
BUS CONT 1 SJCRH

  • Multiple drugs of abuse IVD, control
BUSULFAN CALIBRATOR LEVEL 6 V2
UTAK LABORATORIES, INC.
BUS CAL 6 V2 DP F MDACC
In Commercial Distribution

  • B800BUSCAL6V2DPFMDACC5 ()
  • B800BUSCAL6V2DPFMDACC0 ()

  • Total Volume: 1.5 Milliliter
BUS CAL 6 V2 DP F MDACC

  • Multiple-type clinical chemistry analyte profile IVD, control
BUSULFAN CALIBRATOR LEVEL 6
UTAK LABORATORIES, INC.
BUS CAL 6 SJCR
In Commercial Distribution

  • B800BUSCAL6SJCR5 ()
  • B800BUSCAL6SJCR0 ()

  • Total Volume: 5 Milliliter
BUS CAL 6 SJCR

  • Multiple drugs of abuse IVD, control
BUSULFAN CALIBRATOR LEVEL 5 V2
UTAK LABORATORIES, INC.
BUS CAL 5 V2 DP F MDACC
In Commercial Distribution

  • B800BUSCAL5V2DPFMDACC5 ()
  • B800BUSCAL5V2DPFMDACC0 ()

  • Total Volume: 1.5 Milliliter
BUS CAL 5 V2 DP F MDACC

  • Multiple-type clinical chemistry analyte profile IVD, control
BUSULFAN CALIBRATOR LEVEL 5
UTAK LABORATORIES, INC.
BUS CAL 5 SJCR
In Commercial Distribution

  • B800BUSCAL5SJCR5 ()
  • B800BUSCAL5SJCR0 ()

  • Total Volume: 5 Milliliter
BUS CAL 5 SJCR

  • Multiple drugs of abuse IVD, control
BUSULFAN LEVEL 2 V2
UTAK LABORATORIES, INC.
BUS 2 V2 P F EBS UK
In Commercial Distribution

  • B800BUS2V2PFEBSUK5 ()
  • B800BUS2V2PFEBSUK0 ()

  • Total Volume: 3 Milliliter
BUS 2 V2 P F EBS UK

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

  • B800BUPLOWUKP5 ()
  • B800BUPLOWUKP0 ()

  • Total Volume: 1 Milliliter
BUP+ LOW U KP

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

  • B800BUPHSMXUFPATH5 ()
  • B800BUPHSMXUFPATH0 ()

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

  • Multiple-type clinical chemistry analyte profile IVD, control
BUPRENORPHINE GLUCURONIDE V2
UTAK LABORATORIES, INC.
BUP GLUC+ QC V2 U F HCMC
In Commercial Distribution

  • B800BUPGLUCQCV2UFHCMC5 ()
  • B800BUPGLUCQCV2UFHCMC0 ()

  • Total Volume: 2 Milliliter
BUP GLUC+ QC V2 U F HCMC

  • Multiple-type clinical chemistry analyte profile IVD, control
BUPRENORPHINE PLUS LEVEL 4
UTAK LABORATORIES, INC.
BUP+ 4 U KP
In Commercial Distribution

  • B800BUP4UKP5 ()
  • B800BUP4UKP0 ()

  • Total Volume: 1 Milliliter
BUP+ 4 U KP

  • Multiple therapeutic drugs/drugs of abuse IVD, control
BUPRENORPHINE PLUS LEVEL 3 V2
UTAK LABORATORIES, INC.
BUP+ 3 V2 U F MAYO
In Commercial Distribution

  • B800BUP3V2UFMAYO5 ()
  • B800BUP3V2UFMAYO0 ()

  • Total Volume: 1 Milliliter
BUP+ 3 V2 U F MAYO

  • Multiple-type clinical chemistry analyte profile IVD, control
BUPRENORPHINE PLUS LEVEL 3
UTAK LABORATORIES, INC.
BUP+ 3 U KP
In Commercial Distribution

  • B800BUP3UKP5 ()
  • B800BUP3UKP0 ()

  • Total Volume: 1 Milliliter
BUP+ 3 U KP

  • Multiple therapeutic drugs/drugs of abuse IVD, control
BUPRENORPHINE PLUS LEVEL 2 V2
UTAK LABORATORIES, INC.
BUP+ 2 V2 U KP
In Commercial Distribution

  • B800BUP2V2UKP5 ()
  • B800BUP2V2UKP0 ()

  • Total Volume: 1 Milliliter
BUP+ 2 V2 U KP

  • Multiple drugs of abuse IVD, control
BUPRENORPHINE PLUS LEVEL 2 V2
UTAK LABORATORIES, INC.
BUP+ 2 V2 U F MAYO
In Commercial Distribution

  • B800BUP2V2UFMAYO5 ()
  • B800BUP2V2UFMAYO0 ()

  • Total Volume: 1 Milliliter
BUP+ 2 V2 U F MAYO

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

  • B800BUP2UKP5 ()
  • B800BUP2UKP0 ()

  • Total Volume: 1 Milliliter
BUP+ 2 U KP

  • Multiple therapeutic drugs/drugs of abuse IVD, control
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