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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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 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
THC PLUS LEVEL 1
UTAK LABORATORIES, INC.
THC+ 1 V WB F EPCCO
In Commercial Distribution

  • B800THC1VWBFEPCCO5 ()
  • B800THC1VWBFEPCCO0 ()

  • Total Volume: 3 Milliliter
THC+ 1 V WB F EPCCO

  • Multiple drugs of abuse IVD, control
THC PLUS LEVEL 1
UTAK LABORATORIES, INC.
THC+ 1 V2 U NJSP
In Commercial Distribution

  • B800THC1V2UNJSP5 ()
  • B800THC1V2UNJSP0 ()

  • Total Volume: 5 Milliliter
THC+ 1 V2 U NJSP

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

  • B800THC1UFWCT5 ()
  • B800THC1UFWCT0 ()

  • Total Volume: 10 Milliliter
THC+ 1 U F WCT

  • Multiple-type clinical chemistry analyte profile IVD, control
THC 150 NG/ML
UTAK LABORATORIES, INC.
THC 150 U PM
In Commercial Distribution

  • B800THC150UPM5 ()
  • B800THC150UPM0 ()

  • Total Volume: 10 Milliliter
THC 150 U PM

  • Multiple drugs of abuse IVD, control
THC 150 NG/ML
UTAK LABORATORIES, INC.
THC 150 U ADX
In Commercial Distribution

  • B800THC150UADX5 ()
  • B800THC150UADX0 ()

  • Total Volume: 10 Milliliter
THC 150 U ADX

  • Multiple-type clinical chemistry analyte profile IVD, control
THC 1500 NG/ML
UTAK LABORATORIES, INC.
THC 1500 U PM
In Commercial Distribution

  • B800THC1500UPM5 ()
  • B800THC1500UPM0 ()

  • Total Volume: 10 Milliliter
THC 1500 U PM

  • Multiple drugs of abuse IVD, control
OXY THC LEVEL 2
UTAK LABORATORIES, INC.
OXY THC 2 F OL
In Commercial Distribution

  • B800OXYTHC2FOL5 ()
  • B800OXYTHC2FOL0 ()

  • Total Volume: 25 Milliliter
OXY THC 2 F OL

  • Multiple-type clinical chemistry analyte profile IVD, control
OXY THC LEVEL 1
UTAK LABORATORIES, INC.
OXY THC 1 F OL
In Commercial Distribution

  • B800OXYTHC1FOL5 ()
  • B800OXYTHC1FOL0 ()

  • Total Volume: 25 Milliliter
OXY THC 1 F OL

  • Multiple-type clinical chemistry analyte profile IVD, control
THC PLUS LEVEL 9
UTAK LABORATORIES, INC.
THC+ 9 U F WCT
In Commercial Distribution

  • B800THC9UFWCT5 ()
  • B800THC9UFWCT0 ()

  • Total Volume: 10 Milliliter
THC+ 9 U F WCT

  • Multiple-type clinical chemistry analyte profile IVD, control
THC PLUS LEVEL 8
UTAK LABORATORIES, INC.
THC+ 8 U F WCT
In Commercial Distribution

  • B800THC8UFWCT5 ()
  • B800THC8UFWCT0 ()

  • Total Volume: 10 Milliliter
THC+ 8 U F WCT

  • Multiple-type clinical chemistry analyte profile IVD, control
THC PLUS LEVEL 7
UTAK LABORATORIES, INC.
THC+ 7 U F WCT
In Commercial Distribution

  • B800THC7UFWCT5 ()
  • B800THC7UFWCT0 ()

  • Total Volume: 10 Milliliter
THC+ 7 U F WCT

  • Multiple-type clinical chemistry analyte profile IVD, control
THC PLUS LEVEL 4
UTAK LABORATORIES, INC.
THC+ 4 U F WCT
In Commercial Distribution

  • B800THC4UFWCT5 ()
  • B800THC4UFWCT0 ()

  • Total Volume: 10 Milliliter
THC+ 4 U F WCT

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

  • B800THC3UFWCT5 ()
  • B800THC3UFWCT0 ()

  • Total Volume: 10 Milliliter
THC+ 3 U F WCT

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

  • B800THC2WB2PTFSDHL5 ()
  • B800THC2WB2PTFSDHL0 ()

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

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

  • B800THC2VWBFEPCCO5 ()
  • B800THC2VWBFEPCCO0 ()

  • Total Volume: 3 Milliliter
THC+ 2 V WB F EPCCO

  • Multiple drugs of abuse 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 1
UTAK LABORATORIES, INC.
THC+ 1 WB 2PT F LSA
In Commercial Distribution

  • B800THC1WB2PTFLSA5 ()
  • B800THC1WB2PTFLSA0 ()
THC+ 1 WB 2PT F LSA

  • Multiple-type clinical chemistry analyte profile IVD, control
THC PLUS LEVEL 1
UTAK LABORATORIES, INC.
THC+ 1 V2 WB NJSP
In Commercial Distribution

  • B800THC1V2WBNJSP5 ()
  • B800THC1V2WBNJSP0 ()

  • Total Volume: 5 Milliliter
THC+ 1 V2 WB NJSP

  • Multiple-type clinical chemistry analyte profile IVD, control
THC 1500 NG/ML
UTAK LABORATORIES, INC.
THC 1500 U ADX
In Commercial Distribution

  • B800THC1500UADX5 ()
  • B800THC1500UADX0 ()

  • Total Volume: 10 Milliliter
THC 1500 U ADX

  • Multiple-type clinical chemistry analyte profile IVD, control
THC PLUS LEVEL 11
UTAK LABORATORIES, INC.
THC+ 11 U F WCT
In Commercial Distribution

  • B800THC11UFWCT5 ()
  • B800THC11UFWCT0 ()

  • Total Volume: 10 Milliliter
THC+ 11 U F WCT

  • Multiple-type clinical chemistry analyte profile IVD, control
THC PLUS LEVEL 10
UTAK LABORATORIES, INC.
THC+ 10 U F WCT
In Commercial Distribution

  • B800THC10UFWCT5 ()
  • B800THC10UFWCT0 ()

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

  • Multiple-type clinical chemistry analyte profile IVD, control
THC Rapid Test Cassette
ACRO BIOTECH INC
1
In Commercial Distribution

  • 00853691007168 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
15 THC test dip-cards
IDUN SOLUTIONS LLC
IDTH-115-15P
Not in Commercial Distribution

  • 00857275007124 ()
  • 00857275007025 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
COC/MET1000/THC DipCard
Twin Spirit Inc.
30300D
Not in Commercial Distribution

  • 00859144006320 ()
30300D

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC urine test card
Guangzhou Decheng Biotechnology Co., LTD
2551D2X010
Not in Commercial Distribution

  • 06974464590091 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
THC Screen Test Dipcard
Co-Innovation Biotech Co., Ltd
THC Screen Test
Not in Commercial Distribution

  • 26970429843114 ()
  • 06970429843110 ()
  • 16970429843117 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
Rapid THC Test Dipcard
Co-Innovation Biotech Co., Ltd
THCDIP
In Commercial Distribution

  • 06970429840539 ()
  • 06970429840522 ()
  • 06970429840515 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
Immutest AMP+MET+THC
AMEDITECH INC.
IMD-3AMJ
Not in Commercial Distribution

  • 00816565021295 ()
IMD-3AMJ

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC single drug dipcard
AMEDITECH INC.
IMD-THC
Not in Commercial Distribution

  • 00816565020069 ()
IMD-THC

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Card, (COC/THC)+THC+BZO+MTD+OPI300+OXY
Instant Technologies, Inc.
PSD-6MTDBO300
Not in Commercial Distribution

  • 00817405020737 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Card, (COC/THC)+THC+BZO+MTD+OPI300+OXY
Instant Tech Subsidiary Acquisition
PSD-6MTDBO300
Not in Commercial Distribution

  • 00858998006852 ()
PSD-6MTDBO300

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Cannabinoids (Thc) Atellica CH - RGT 1520T
Siemens Healthcare Diagnostics Inc.
11097503
In Commercial Distribution

  • 00630414596099 ()
11097503

  • Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
HairCheck-DT (THC) is an ELISA test kit used for qualitative detection of THC-COOH in head hair with a cutoff of 1.0 pg/mg of hair. Kit is comprised of 4 component packages: Microplates, Conjugate Reagents, Common Reagents, and Calibrator/Controls.
Quest Diagnostics
PVJ-Exempt
In Commercial Distribution

  • 00868586000261 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
The Randox Cannabinoid Control - Level 2 is intended for use in the Quality Control of the 11-nor-Δ9-THC-9-COOH (Cannabinoid) assay. The Cannabinoid Control Level 2 contains the specific drug Cannabinoid.
RANDOX LABORATORIES LIMITED
DA3128
In Commercial Distribution

  • 05055273207965 ()
DA3128

  • Cannabinoid/cannabinoid metabolite IVD, control
The Randox Cannabinoid Control - Level 1 is intended for use in the Quality Control of the 11-nor-Δ9-THC-9-COOH (Cannabinoid) assay. The Cannabinoid Control Level 1 contains the specific drug Cannabinoid.
RANDOX LABORATORIES LIMITED
DA3127
In Commercial Distribution

  • 05055273207958 ()
DA3127

  • Cannabinoid/cannabinoid metabolite IVD, control
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