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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COC/MET/MOR/OXY/THC
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARD05041 ()
  • B115ABCARD05040 ()
ABCard-05-04

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP/COC/MET/MOR/THC
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARD05021 ()
  • B115ABCARD05020 ()
ABCard-05-02

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP/BAR/BZO/COC/THC
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARD05011 ()
  • B115ABCARD05010 ()
ABCard-05-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
iCassette THC Dev(Urine) 25T
Instant Technologies, Inc.
DTH-102
In Commercial Distribution

  • 30817405022558 ()
  • 00817405022557 ()
  • 10817405022554 ()
DTH-102

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
iScreen THC Panel(Urine) 25T
Instant Technologies, Inc.
DTH-114
In Commercial Distribution

  • 30817405022312 ()
  • 00817405022311 ()
  • 10817405022318 ()
DTH-114

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immutest MET+THC Test Card
AMEDITECH INC.
IMD-2AMJ
Not in Commercial Distribution

  • 00816565021271 ()
IMD-2AMJ

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
1-Panel Cassette; THC Marijuana/Cannabinoids
WONDFO USA CO., LTD.
WDTH-201
In Commercial Distribution

  • 10816862020837 ()
  • 00816862020830 ()
  • 00816862029833 ()
WDTH-201

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
1-Panel Card; THC Marijuana/Cannabinoids
WONDFO USA CO., LTD.
WDTH-114
In Commercial Distribution

  • 10816862020820 ()
  • 00816862020823 ()
  • 00816862029826 ()
WDTH-114

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
3-Panel Card; COC,mAMP,THC
WONDFO USA CO., LTD.
WDOA-234
In Commercial Distribution

  • 10816862020554 ()
  • 00816862020557 ()
  • 00816862029550 ()
WDOA-234

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
3-Panel Card; COC,mAMP,THC
WONDFO USA CO., LTD.
WDOA-234
In Commercial Distribution

  • 00816862025552 ()
WDOA-234

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
1-Panel Cassette; THC Marijuana/Cannabinoids
WONDFO USA CO., LTD.
WDTH-201
In Commercial Distribution

  • 00816862025835 ()
WDTH-201

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
1-Panel Card; THC Marijuana/Cannabinoids
WONDFO USA CO., LTD.
WDTH-114
In Commercial Distribution

  • 00816862025828 ()
WDTH-114

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Single Dip Drug Test, THC
Express Diagnostic Int'l, Inc.
30140
In Commercial Distribution

  • B2983014010 ()
30140

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
Single Dip Drug Test, THC
EXPRESS DIAGNOSTICS INT'L, INC.
30140
Not in Commercial Distribution

  • B298301400 ()
30140

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
OrtFlx Com McLaughlin 022 L1/2 Rx -6º Tor. 0º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-841
In Commercial Distribution

  • 00190730002341 ()


  • Orthodontic bracket, plastic, single-use
OrtFlx Com McLaughlin 022 U4/5 Rx -7º Tor. 0º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-830
In Commercial Distribution

  • 00190730002303 ()


  • Orthodontic bracket, plastic, single-use
OrtFlx Com McLaughlin 018 L1/2 Rx -6º Tor. 0º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-741
In Commercial Distribution

  • 00190730001962 ()


  • Orthodontic bracket, plastic, single-use
OrtFlx Com McLaughlin 018 U4/5 Rx -7º Tor. 0º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-730
In Commercial Distribution

  • 00190730001924 ()


  • Orthodontic bracket, plastic, single-use
Avalon Com Roth 022 L1/2 Rx -6º Tor. 0º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
A22-841
In Commercial Distribution

  • 00190730000644 ()


  • Orthodontic bracket, plastic, single-use
Avalon Com Roth 018 L1/2 Rx -6° Tor. 0° Ang.(10PK)
ORTHO TECHNOLOGY, INC.
A18-741
Not in Commercial Distribution

  • 00190730000460 ()


  • Orthodontic bracket, plastic, single-use
25 tests kit;THC Single Panel
EASY HEALTHCARE CORPORATION
EDTH-114
In Commercial Distribution

  • 10850253007298 ()
  • 00850253007291 ()
  • 30850253007292 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
CLIA Waived Marijuana Single Strip (THC)
Medical Disposables Corp
M-DTH-101
In Commercial Distribution

  • 00850969007080 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived Marijuana Test Panel (THC)
Medical Disposables Corp
M-DTH-114
In Commercial Distribution

  • 00850969007073 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived Marijuana Single Strip (THC)
Medical Disposables Corp
M-DTH-101
In Commercial Distribution

  • 00851721007249 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived Marijuana Test Panel (THC)
Medical Disposables Corp
M-DTH-114
In Commercial Distribution

  • 00851721007232 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived Marijuana Test Panel (THC)
Medical Disposables Corp
M-DTH-114
In Commercial Distribution

  • 00851721007188 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived Marijuana Single Strip (THC)
Medical Disposables Corp
M-DTH-101
In Commercial Distribution

  • 00851721007171 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 tests kit;THC Single Panel
EASY HEALTHCARE CORPORATION
EDTH-114
Not in Commercial Distribution

  • 00855944007642 ()
  • 30855944007643 ()
EDTH-114-12

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
6 tests kit;THC Single Panel
EASY HEALTHCARE CORPORATION
EDTH-114
In Commercial Distribution

  • 00855944007482 ()
  • 30855944007483 ()
EDTH-114-6

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
5 tests kit;THC Single Panel
EASY HEALTHCARE CORPORATION
EDTH-114
In Commercial Distribution

  • 00855944007475 ()
  • 30855944007476 ()
EDTH-114-5

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
20 tests kit;THC Single Panel
EASY HEALTHCARE CORPORATION
EDTH-114
In Commercial Distribution

  • 10855944007465 ()
  • 00855944007468 ()
  • 30855944007469 ()
EDTH-114-20

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
AMP/BAR/COC/OPI2000/THC Dipcard
Twin Spirit Inc.
30530D
Not in Commercial Distribution

  • 00859144006306 ()
30530D

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP/BZO/COC/OPI2000/THC Dipcard
Twin Spirit Inc.
30520D
Not in Commercial Distribution

  • 00859144006290 ()
30520D

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP/BAR/BZO/COC/THC DipCard
Twin Spirit Inc.
30510D
Not in Commercial Distribution

  • 00859144006283 ()
30510D

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP/COC/MET1000/OPI2000/THC DipCard
Twin Spirit Inc.
30500D
Not in Commercial Distribution

  • 00859144006276 ()
30500D

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC Single Panel Dip Test Card
UCP BIOSCIENCES, INC.
U-THC-114L
In Commercial Distribution

  • 20817038021198 ()
  • 10817038021191 ()
  • 00817038021194 ()
U-THC-114L

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
THC Single Panel Dip Test Card
UCP BIOSCIENCES, INC.
U-THC-114
In Commercial Distribution

  • 20817038020504 ()
  • 10817038020507 ()
  • 00817038020500 ()
U-THC-114

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
PANEL 04 COC150/AMP1000/THC/MOP300
REDWOOD TOXICOLOGY LABORATORY, INC.
011020199
In Commercial Distribution

  • 10858904006584 ()
  • 00858904006587 ()
DOA-144-1041

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 04 COC150/ THC/MOP300/MAMP500
REDWOOD TOXICOLOGY LABORATORY, INC.
011020195
In Commercial Distribution

  • 10858904006577 ()
  • 00858904006570 ()
DOA-144-621

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 4 COC/AMP/THC/OPI
REDWOOD TOXICOLOGY LABORATORY, INC.
011020032
In Commercial Distribution

  • 10858904006232 ()
  • 00858904006235 ()
DOA-844-OBC12B

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