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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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Immunoassay for the detection of the following drug substance(s) in human urine: COC / M-AMP / OPI / PCP / THC
RAPID DIAGNOSTICS INC
07RD7064-02
In Commercial Distribution

  • 00817830021255 ()

  • Length: 75 Millimeter
07RD7064-02

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / COC / OPI / PCP / THC
RAPID DIAGNOSTICS INC
07RD7064-01
In Commercial Distribution

  • 00817830021248 ()

  • Length: 75 Millimeter
07RD7064-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC PLUS LEVEL 5
UTAK LABORATORIES, INC.
THC+ 5 U F WCT
In Commercial Distribution

  • B800THC5UFWCT5 ()
  • B800THC5UFWCT0 ()

  • Total Volume: 10 Milliliter
THC+ 5 U F WCT

  • Multiple-type clinical chemistry analyte profile IVD, control
PENTOBARBITAL 5 UG/ML
UTAK LABORATORIES, INC.
PENTO 5 JHH
In Commercial Distribution

  • B800PENTO5JHH0 ()
  • B800PENTO5JHH5 ()

  • Total Volume: 5 Milliliter
PENTO 5 JHH

  • Multiple-type clinical chemistry analyte profile IVD, control
FENTANYL CALIBRATOR LEVEL 5
UTAK LABORATORIES, INC.
FENT+ CAL 5 U F KP
In Commercial Distribution

  • B800FENTCAL5UFKP5 ()
  • B800FENTCAL5UFKP0 ()

  • Total Volume: 1 Milliliter
FENT+ CAL 5 U F KP

  • Multiple-type clinical chemistry analyte profile IVD, control
FENTANYL PLUS LEVEL 5
UTAK LABORATORIES, INC.
FENT+ 5 U QD
In Commercial Distribution

  • B800FENT5UQD5 ()
  • B800FENT5UQD0 ()

  • Total Volume: 20 Milliliter
FENT+ 5 U QD

  • Multiple drugs of abuse IVD, control
ETG PLUS CALIBRATOR 5
UTAK LABORATORIES, INC.
ETG+ CAL 5 U F NPIL
In Commercial Distribution

  • B800ETGCAL5UFNPIL5 ()
  • B800ETGCAL5UFNPIL0 ()

  • Total Volume: 2 Milliliter
ETG+ CAL 5 U F NPIL

  • Multiple-type clinical chemistry analyte profile IVD, control
DAU CALIBRATOR LEVEL 5
UTAK LABORATORIES, INC.
DAU CAL 5 F ERSO
In Commercial Distribution

  • B800DAUCAL5FERSO5 ()
  • B800DAUCAL5FERSO0 ()

  • Total Volume: 4 Milliliter
DAU CAL 5 F ERSO

  • Multiple drugs of abuse IVD, control
MORPHINE 5 NG/M
UTAK LABORATORIES, INC.
pos-m245-1-2ml
In Commercial Distribution

  • B800POSM24512ML0 ()

  • Total Volume: 2 Milliliter
pos-m245-1-2ml

  • Multiple-therapy therapeutic drug monitoring 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
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