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 Class Implantable

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AMP/COC/THC
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARD03011 ()
  • B115ABCARD03010 ()
ABCard-03-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC COOH HYDROLYSIS QC
UTAK LABORATORIES, INC.
91804 TRL
In Commercial Distribution

  • B80091804TRL5 ()
  • B80091804TRL0 ()

  • Total Volume: 3 Milliliter
91804 TRL

  • Multiple-type clinical chemistry analyte profile IVD, control
THC COOH HYDROLYSIS QC
UTAK LABORATORIES, INC.
91804
In Commercial Distribution

  • B800918045 ()
  • B800918040 ()

  • Total Volume: 3 Milliliter
91804

  • Cannabinoid/cannabinoid metabolite IVD, control
DAU THC LEVEL 1
UTAK LABORATORIES, INC.
DAU THC 1 F OL
In Commercial Distribution

  • B800DAUTHC1FOL5 ()
  • B800DAUTHC1FOL0 ()

  • Total Volume: 25 Milliliter
DAU THC 1 F OL

  • Multiple-type clinical chemistry analyte profile IVD, control
THC PLUS LEVEL 3
UTAK LABORATORIES, INC.
THC+ 3 WB 2PT F LSA
In Commercial Distribution

  • B800THC3WB2PTFLSA5 ()
  • B800THC3WB2PTFLSA0 ()
THC+ 3 WB 2PT F LSA

  • Multiple-type clinical chemistry analyte profile IVD, control
THC PLUS LEVEL 2
UTAK LABORATORIES, INC.
THC+ 2 WB 2PT F LSA
In Commercial Distribution

  • B800THC2WB2PTFLSA5 ()
  • B800THC2WB2PTFLSA0 ()
THC+ 2 WB 2PT F LSA

  • Multiple-type clinical chemistry analyte profile IVD, control
THC PLUS LEVEL 2
UTAK LABORATORIES, INC.
THC+ 2 V2 WB NJSP
In Commercial Distribution

  • B800THC2V2WBNJSP5 ()
  • B800THC2V2WBNJSP0 ()

  • Total Volume: 5 Milliliter
THC+ 2 V2 WB NJSP

  • Multiple-type clinical chemistry analyte profile IVD, control
THC PLUS LEVEL 2
UTAK LABORATORIES, INC.
THC+ 2 V2 U NJSP
In Commercial Distribution

  • B800THC2V2UNJSP5 ()
  • B800THC2V2UNJSP0 ()

  • Total Volume: 5 Milliliter
THC+ 2 V2 U NJSP

  • Multiple-type clinical chemistry analyte profile IVD, control
THC PLUS LEVEL 2
UTAK LABORATORIES, INC.
THC+ 2 U F WCT
In Commercial Distribution

  • B800THC2UFWCT5 ()
  • B800THC2UFWCT0 ()

  • Total Volume: 10 Milliliter
THC+ 2 U F WCT

  • Multiple-type clinical chemistry analyte profile IVD, control
THC PLUS LEVEL 1
UTAK LABORATORIES, INC.
THC+ 1 WB 2PT F SDHL
In Commercial Distribution

  • B800THC1WB2PTFSDHL5 ()
  • B800THC1WB2PTFSDHL0 ()

  • Total Volume: 1 Milliliter
THC+ 1 WB 2PT F SDHL

  • Multiple-type clinical chemistry analyte profile IVD, control
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