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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METHAMPHETAMINE CAL SET
UTAK LABORATORIES, INC.
POS-M2220-2-3
In Commercial Distribution

  • B800POSM2220235 ()

  • Total Volume: 2 Milliliter
POS-M2220-2-3

  • Multiple drugs of abuse IVD, control
METHAMPHETAMINES URINE KIT
UTAK LABORATORIES, INC.
POS-M220U-4-4
In Commercial Distribution

  • B800POSM220U445 ()

  • Total Volume: 4 Milliliter
POS-M220U-4-4

  • Multiple drugs of abuse IVD, control
METHAMPHETAMINE 500 NG/ML
UTAK LABORATORIES, INC.
POS-M220-3-2ML
In Commercial Distribution

  • B800POSM22032ML0 ()

  • Total Volume: 2 Milliliter
POS-M220-3-2ML

  • Multiple drugs of abuse IVD, control
METHAMPHETAMINE CAL SET
UTAK LABORATORIES, INC.
POS-M220-2-3
In Commercial Distribution

  • B800POSM220230 ()

  • Total Volume: 2 Milliliter
POS-M220-2-3

  • Multiple drugs of abuse IVD, control
METHAMPHETAMINE 100 NG/ML
UTAK LABORATORIES, INC.
POS-M220-2-2ML
In Commercial Distribution

  • B800POSM22022ML0 ()

  • Total Volume: 2 Milliliter
POS-M220-2-2ML

  • Multiple drugs of abuse IVD, control
METHAMPHETAMINE 25 NG/ML
UTAK LABORATORIES, INC.
POS-M220-1-2ML
In Commercial Distribution

  • B800POSM22012ML0 ()

  • Total Volume: 2 Milliliter
POS-M220-1-2ML

  • Multiple drugs of abuse IVD, control
METHADONE CAL SET
UTAK LABORATORIES, INC.
POS-M215-2-4
In Commercial Distribution

  • B800POSM215245 ()
  • B800POSM215240 ()

  • Total Volume: 2 Milliliter
POS-M215-2-4

  • Multiple drugs of abuse IVD, control
CANNABINOIDS URINE KIT
UTAK LABORATORIES, INC.
POS-M145U-4-4
In Commercial Distribution

  • B800POSM145U445 ()

  • Total Volume: 4 Milliliter
POS-M145U-4-4

  • Multiple drugs of abuse IVD, control
CANNABINOIDS CAL SET
UTAK LABORATORIES, INC.
POS-M145-2-3
In Commercial Distribution

  • B800POSM145235 ()
  • B800POSM145230 ()

  • Total Volume: 2 Milliliter
POS-M145-2-3

  • Multiple drugs of abuse IVD, control
BUPRENORPHINE POS
UTAK LABORATORIES, INC.
POS-236-2U
In Commercial Distribution

  • B800POS2362U5 ()
  • B800POS2362U0 ()

  • Total Volume: 2 Milliliter
POS-236-2U

  • Multiple drugs of abuse IVD, control
TRAMADOL POS
UTAK LABORATORIES, INC.
POS-225-2U
In Commercial Distribution

  • B800POS2252U5 ()
  • B800POS2252U0 ()

  • Total Volume: 2 Milliliter
POS-225-2U

  • Multiple drugs of abuse IVD, control
METHAMPHETAMINE POS
UTAK LABORATORIES, INC.
POS-211-2U
In Commercial Distribution

  • B800POS2112U5 ()
  • B800POS2112U0 ()

  • Total Volume: 2 Milliliter
POS-211-2U

  • Multiple drugs of abuse IVD, control
BENZOYLECGONINE POS
UTAK LABORATORIES, INC.
POS-206-2U
In Commercial Distribution

  • B800POS2062U0 ()

  • Total Volume: 2 Milliliter
POS-206-2U

  • Multiple drugs of abuse IVD, control
PAIN MANAGEMENT PLUS
UTAK LABORATORIES, INC.
PM+ U F CCL
In Commercial Distribution

  • B800PMUFCCL5 ()
  • B800PMUFCCL0 ()

  • Total Volume: 5 Milliliter
PM+ U F CCL

  • Multiple drugs of abuse IVD, control
PETH LEVEL 7 V2
UTAK LABORATORIES, INC.
PETH 7 V2 WB F HFHS
In Commercial Distribution

  • B800PETH7V2WBFHFHS5 ()
  • B800PETH7V2WBFHFHS0 ()

  • Total Volume: 2 Milliliter
PETH 7 V2 WB F HFHS

  • Multiple drugs of abuse IVD, control
PETH LEVEL 6 V2
UTAK LABORATORIES, INC.
PETH 6 V2 WB F HFHS
In Commercial Distribution

  • B800PETH6V2WBFHFHS5 ()
  • B800PETH6V2WBFHFHS0 ()

  • Total Volume: 2 Milliliter
PETH 6 V2 WB F HFHS

  • Multiple drugs of abuse IVD, control
PETH LEVEL 5 V2
UTAK LABORATORIES, INC.
PETH 5 V2 WB F HFHS
In Commercial Distribution

  • B800PETH5V2WBFHFHS5 ()
  • B800PETH5V2WBFHFHS0 ()

  • Total Volume: 2 Milliliter
PETH 5 V2 WB F HFHS

  • Multiple drugs of abuse IVD, control
Status DS Control Set (Neg&Pos 2.5 ml)
PRINCETON BIOMEDITECH CORPORATION
21000
In Commercial Distribution

  • 10743816001546 ()


  • Multiple drugs of abuse IVD, control
Drugs of Abuse Negative Control, 6x2.5mL
Siemens Healthcare Diagnostics Inc.
10445199
In Commercial Distribution

  • 00842768016479 ()
  • 00630414005294 ()
KC516

  • Multiple drugs of abuse IVD, control
Drugs of Abuse Positive Control, 6x2.5mL
Siemens Healthcare Diagnostics Inc.
10445198
In Commercial Distribution

  • 00842768016462 ()
  • 00630414005287 ()
KC515

  • Multiple drugs of abuse IVD, control
Drugs of Abuse Calibrator, 4x2.5mL / 2x2.6mL
Siemens Healthcare Diagnostics Inc.
10445187
In Commercial Distribution

  • 00842768016455 ()
KC510

  • Multiple drugs of abuse IVD, calibrator
Syva® Emit® II Plus 6-AM /Ecstasy Calibrator/Control Level 4
Siemens Healthcare Diagnostics Inc.
10470444
In Commercial Distribution

  • 00842768034169 ()
9R589UL

  • Multiple drugs of abuse IVD, calibrator
Syva® Emit® II Plus 6-AM /Ecstasy Calibrator/Control Level 3
Siemens Healthcare Diagnostics Inc.
10470443
In Commercial Distribution

  • 00842768034152 ()
9R569UL

  • Multiple drugs of abuse IVD, calibrator
Syva® Emit® II Plus 6-AM /Ecstasy Calibrator/Control Level 2
Siemens Healthcare Diagnostics Inc.
10470442
In Commercial Distribution

  • 00842768034145 ()
9R549UL

  • Multiple drugs of abuse IVD, calibrator
Syva® Emit® II Plus 6-AM /Ecstasy Calibrator/Control Level 1
Siemens Healthcare Diagnostics Inc.
10470441
In Commercial Distribution

  • 00842768034138 ()
9R529UL

  • Multiple drugs of abuse IVD, calibrator
SYNCHRON Systems DAT Negative Urine Calibrator
Beckman Coulter, Inc.
445803
In Commercial Distribution

  • 15099590230517 ()
445803

  • Multiple drugs of abuse IVD, calibrator
SYNCHRON Systems DAT Multi-Drug Low Urine Control
Beckman Coulter, Inc.
474976
In Commercial Distribution

  • 15099590223328 ()
474976

  • Multiple drugs of abuse IVD, control
SYNCHRON Systems DAT Multi-Drug High Urine Control
Beckman Coulter, Inc.
474979
In Commercial Distribution

  • 15099590223311 ()
474979

  • Multiple drugs of abuse IVD, control
SYNCHRON Systems DAT Multi-Drug Low Urine Calibrator
Beckman Coulter, Inc.
474970
In Commercial Distribution

  • 15099590223298 ()
474970

  • Multiple drugs of abuse IVD, calibrator
SYNCHRON System DAT Multi-Drug High Urine Calibrator
Beckman Coulter, Inc.
474973
In Commercial Distribution

  • 15099590223281 ()
474973

  • Multiple drugs of abuse IVD, calibrator
SYNCHRON Systems DAT Drug Free Urine Control
Beckman Coulter, Inc.
469945
In Commercial Distribution

  • 15099590180225 ()
469945

  • Multiple drugs of abuse IVD, control
Triage TOX Drug Screen, 94600 Control 2
QUIDEL CARDIOVASCULAR INC.
94614
In Commercial Distribution

  • 30014613338123 ()
94614

  • Multiple drugs of abuse IVD, control
Triage TOX Drug Screen, 94600 Control 1
QUIDEL CARDIOVASCULAR INC.
94613
In Commercial Distribution

  • 30014613338116 ()
94613

  • Multiple drugs of abuse IVD, control
Quidel Triage TOX Drug Screen Control 2
QUIDEL CARDIOVASCULAR INC.
94414
Not in Commercial Distribution

  • 30014613337140 ()
94414

  • Multiple drugs of abuse IVD, control
Quidel Triage TOX Drug Screen Control 1
QUIDEL CARDIOVASCULAR INC.
94413
Not in Commercial Distribution

  • 30014613337133 ()
94413

  • Multiple drugs of abuse IVD, control
STABILITY/QC CONTROL MENU CD, Cutoff 150%, 50mL
BIOCHEMICAL DIAGNOSTICS INC
18008793
In Commercial Distribution

  • 00810042684447 ()
18008793

  • Multiple drugs of abuse IVD, control
STABILITY/QC CONTROL MENU CD, Cutoff -50%, 50mL
BIOCHEMICAL DIAGNOSTICS INC
18008792
In Commercial Distribution

  • 00810042684430 ()
18008792

  • Multiple drugs of abuse IVD, control
CAL MENU CD, Cutoff 150%, 50mL
BIOCHEMICAL DIAGNOSTICS INC
18008791
In Commercial Distribution

  • 00810042684423 ()
18008791

  • Multiple drugs of abuse IVD, control
CAL MENU CD, Cutoff -50%, 50mL
BIOCHEMICAL DIAGNOSTICS INC
18008790
In Commercial Distribution

  • 00810042684416 ()
18008790

  • Multiple drugs of abuse IVD, control
Positive QC, 25mL
BIOCHEMICAL DIAGNOSTICS INC
Multitox-PC-25G
In Commercial Distribution

  • 00810042684362 ()
Multitox-PC-25G

  • Multiple drugs of abuse IVD, control
FENTANYL 3ng/mL 2x5mL KITBOX
BIOCHEMICAL DIAGNOSTICS INC
702040
In Commercial Distribution

  • 00810042684355 ()
702040

  • Multiple drugs of abuse IVD, control
NW DOA Panel, +25%, 10mL
BIOCHEMICAL DIAGNOSTICS INC
18008623
In Commercial Distribution

  • 00810042684348 ()
18008623

  • Multiple drugs of abuse IVD, control
NW DOA Panel, -25%, 10mL
BIOCHEMICAL DIAGNOSTICS INC
18008622
In Commercial Distribution

  • 00810042684331 ()
18008622

  • Multiple drugs of abuse IVD, control
Cliawaived™ Inc Multitox Urine, POSITIVE QC, 25mL
BIOCHEMICAL DIAGNOSTICS INC
Multitox-PC-25F
In Commercial Distribution

  • 00810042684324 ()
Multitox-PC-25F

  • Multiple drugs of abuse IVD, control
Creatinine 30mg/dL, 10mL
BIOCHEMICAL DIAGNOSTICS INC
19481370
In Commercial Distribution

  • 00810042684317 ()
19481370

  • Multiple drugs of abuse IVD, control
Creatinine 10mg/dL, 10mL
BIOCHEMICAL DIAGNOSTICS INC
19481360
In Commercial Distribution

  • 00810042684300 ()
19481360

  • Multiple drugs of abuse IVD, control
AU/NZ SKREEN23, cutoff +50%, 10mL
BIOCHEMICAL DIAGNOSTICS INC
19481350
In Commercial Distribution

  • 00810042684294 ()
19481350

  • Multiple drugs of abuse IVD, control
AU/NZ SKREEN23, cutoff +25%, 10mL
BIOCHEMICAL DIAGNOSTICS INC
19481340
In Commercial Distribution

  • 00810042684287 ()
19481340

  • Multiple drugs of abuse IVD, control
AU/NZ SKREEN23, cutoff -30%, 10mL
BIOCHEMICAL DIAGNOSTICS INC
19481320
In Commercial Distribution

  • 00810042684270 ()
19481320

  • Multiple drugs of abuse IVD, control
AU/NZ SKREEN23, cutoff -50%, 10mL
BIOCHEMICAL DIAGNOSTICS INC
19481310
In Commercial Distribution

  • 00810042684263 ()
19481310

  • Multiple drugs of abuse IVD, control
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