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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FENTANYL PANEL POSITIVE 1
UTAK LABORATORIES, INC.
FENT+ POS1 U KP
In Commercial Distribution

  • B800FENTPOS1UKP5 ()
  • B800FENTPOS1UKP0 ()

  • Total Volume: 10 Microliter
FENT+ POS1 U KP

  • Multiple drugs of abuse IVD, control
URINE BROAD PANEL MID
UTAK LABORATORIES, INC.
UBP M F DU
In Commercial Distribution

  • B800UBPMFDU5 ()
  • B800UBPMFDU0 ()

  • Total Volume: 1 Milliliter
UBP M F DU

  • Multiple therapeutic drugs/drugs of abuse IVD, control
URINE BROAD PANEL LOW
UTAK LABORATORIES, INC.
UBP L F DU
In Commercial Distribution

  • B800UBPLFDU5 ()
  • B800UBPLFDU0 ()

  • Total Volume: 1 Milliliter
UBP L F DU

  • Multiple therapeutic drugs/drugs of abuse IVD, control
URINE BROAD PANEL HIGH
UTAK LABORATORIES, INC.
UBP H F V DU
In Commercial Distribution

  • B800UBPHFVDU5 ()
  • B800UBPHFVDU0 ()

  • Total Volume: 1 Milliliter
UBP H F V DU

  • Multiple therapeutic drugs/drugs of abuse IVD, control
URINE BROAD PANEL HIGH
UTAK LABORATORIES, INC.
UBP H F DU
In Commercial Distribution

  • B800UBPHFDU5 ()
  • B800UBPHFDU0 ()

  • Total Volume: 1 Milliliter
UBP H F DU

  • Multiple-type clinical chemistry analyte profile IVD, control
TCA PANEL LEVEL 3
UTAK LABORATORIES, INC.
TCA 3 U WBH
In Commercial Distribution

  • B800TCA3UWBH5 ()
  • B800TCA3UWBH0 ()

  • Total Volume: 5 Milliliter
TCA 3 U WBH

  • Multiple drugs of abuse IVD, control
PSYCH PANEL LEVEL 2
UTAK LABORATORIES, INC.
PSYCH 2 F M ACL
In Commercial Distribution

  • B800PSYCH2FMACL5 ()
  • B800PSYCH2FMACL0 ()

  • Total Volume: 3 Milliliter
PSYCH 2 F M ACL

  • Multiple-type clinical chemistry analyte profile IVD, control
ELR PANEL&HDW BLUE-PR
GF HEALTH PRODUCTS, INC.
90763132
In Commercial Distribution

  • M368907631321 ()
90763132

  • Wheelchair legrest pad
ELR PANEL&HDW BLACK-PR
GF HEALTH PRODUCTS, INC.
90763032A
In Commercial Distribution

  • M36890763032A1 ()
90763032A

  • Wheelchair legrest pad
No Description
TREK DIAGNOSTIC SYSTEMS LIMITED
GPID
In Commercial Distribution

  • M578GPID2 ()
  • M578GPID0 ()


  • Gram positive bacteria species culture isolate identification/antimicrobial susceptibility profile IVD, kit
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