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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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THC PLUS LEVEL 3 - B800THC3WB2PTFLSA0

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 - B800THC2WB2PTFLSA0

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 - B800THC2V2WBNJSP0

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 - B800THC2UFWCT0

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 - B800THC1WB2PTFSDHL0

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 - B800THC1VWBFEPCCO0

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 - B800THC1V2UNJSP0

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 - B800THC1UFWCT0

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 - B800THC150UPM0

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 - B800THC150UADX0

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 - B800THC1500UPM0

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 - B800OXYTHC2FOL0

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 - B800OXYTHC1FOL0

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 - B800THC9UFWCT0

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 - B800THC8UFWCT0

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 - B800THC7UFWCT0

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 - B800THC4UFWCT0

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 - B800THC3UFWCT0

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 - B800THC2WB2PTFSDHL0

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 - B800THC2VWBFEPCCO0

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 - B800THC2V2UNJSP0

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 - B800THC1WB2PTFLSA0

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 - B800THC1V2WBNJSP0

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 - B800THC1500UADX0

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 - B800THC11UFWCT0

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 - B800THC10UFWCT0

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 - 00853691007168

THC Rapid Test Cassette
ACRO BIOTECH INC
1
In Commercial Distribution

  • 00853691007168 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)

Preknow THC (Marijuana) Single Drug Screen Test (15 Dipcards) - 00857275007124

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

DrugSmart Dip - 00859144006320

COC/MET1000/THC DipCard
Twin Spirit Inc.
30300D
Not in Commercial Distribution

  • 00859144006320 ()
30300D

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Dochek - 06974464590091

THC urine test card
Guangzhou Decheng Biotechnology Co., LTD
2551D2X010
Not in Commercial Distribution

  • 06974464590091 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical

AICARE - 06970429843110

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

co-innovation - 06970429840515

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 Drugs of Abuse Screen Device - 00816565021295

Immutest AMP+MET+THC
AMEDITECH INC.
IMD-3AMJ
Not in Commercial Distribution

  • 00816565021295 ()
IMD-3AMJ

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

ImmuTest Drugs of Abuse Screen Card - 00816565020069

THC single drug dipcard
AMEDITECH INC.
IMD-THC
Not in Commercial Distribution

  • 00816565020069 ()
IMD-THC

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical

ProScreen - 00817405020737

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

ProScreen - 00858998006852

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

Atellica CH Thc - 00630414596099

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) Exempt - 00868586000261

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)

THC CONTROL 2 - 05055273207965

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

THC CONTROL 1 - 05055273207958

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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