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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9-Panel Card; AMP,BUP,BZO,COC,MOP,MTD,OXY,PPX,THC
WONDFO USA CO., LTD.
WDOA-295
In Commercial Distribution

  • 00816862025590 ()
WDOA-295

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel T-Square no THC with Indicator; AMP,COC,MET,OPI,PCP
WONDFO USA CO., LTD.
QODOA-156NTEUO-I
In Commercial Distribution

  • 10816862023418 ()
  • 00816862023411 ()
  • 00816862023428 ()
QODOA-156NTEUO-I

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7-Panel T-Square with Indicator; AMP,COC,MET,OPI,OXY,PCP,THC
WONDFO USA CO., LTD.
QODOA-376EUO-I
In Commercial Distribution

  • 10816862023081 ()
  • 00816862023084 ()
  • 00816862023091 ()
QODOA-376EUO-I

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7-Panel Preview Dip Card; AMP, BZO, COC, mAMP, OPI, OXY, THC
WONDFO USA CO., LTD.
PRE-WDOA-274
In Commercial Distribution

  • 10816862021469 ()
  • 00816862021462 ()
  • 00816862028461 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DrugSmart Cup 5, AMP/COC/OPI/OXY/THC, 25 tests/kit
CHEMTRON BIOTECH INC
60565D
In Commercial Distribution

  • 00812203030124 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP+MET+THC with Cr, Ni, pH, Bl, S.G. adulteration tests
AMEDITECH INC.
IMDA-3AMJ
Not in Commercial Distribution

  • 00816565021301 ()
IMDA-3AMJ

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC, COC, OPI, AMP, MET, PCP, BAR, BZO, MTD, TCA, OXY
BRANAN MEDICAL CORPORATION
C-60B02
Not in Commercial Distribution

  • 00816555021472 ()
C-60B02

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7 panel test cup, AMP/BAR/BZO/COC/OPI2000/PCP/THC
AMEDITECH INC.
IMC-7P
Not in Commercial Distribution

  • 00816565020168 ()
IMC-7P

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
(BZO/BAR)+(COC/THC)+(PCP/AMP)+MET1000+TCA multiple drugs dipcard
AMEDITECH INC.
IMD-8MT
Not in Commercial Distribution

  • 00816565020083 ()
IMD-8MT

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP1000/BUP5/BZO300/COC150/MET1000/OPI300/OXY/THC/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCUPA08051 ()
  • B115ABCUPA08050 ()
ABCupA-08-05

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP/BUP/BZO/COC/MOR/MTD/OXY/THC/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCUPA08011 ()
  • B115ABCUPA08010 ()
ABCupA-08-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/BZO300/COC150/ETG/K2/MDMA/MET500/MOR300/OXY/PCP/THC
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCUP12101 ()
  • B115ABCUP12100 ()
ABCup-12-10

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

  • B115ABCUP11071 ()
  • B115ABCUP11070 ()
ABCup-11-07

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

  • B115ABCUP11041 ()
  • B115ABCUP11040 ()
ABCup-11-04

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

  • B115ABCUP11011 ()
  • B115ABCUP11010 ()
ABCup-11-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP1000/BUP5/BZO300/COC150/MET1000/OPI300/OXY/THC/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARDA08051 ()
  • B115ABCARDA08050 ()
ABCardA-08-05

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP/BUP/BZO/COC/MOR/MTD/OXY/THC/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARDA08011 ()
  • B115ABCARDA08010 ()
ABCardA-08-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/BZO300/COC150/ETG/K2/MDMA/MET500/MOR300/OXY/PCP/THC
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARD12101 ()
  • B115ABCARD12100 ()
ABCard-12-10

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

  • B115ABCARD11071 ()
  • B115ABCARD11070 ()
ABCard-11-07

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

  • B115ABCARD11041 ()
  • B115ABCARD11040 ()
ABCard-11-04

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

  • B115ABCARD11011 ()
  • B115ABCARD11010 ()
ABCard-11-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Biotem IR COM OCTA PLUS ABUTMENT 4.8 mm (D) X 2.9 (Octa) X 4.0 mm(Cuff) X 6.0 mm(H)
Biotem Co., ltd
SAITB4846C
In Commercial Distribution

  • 08800036204173 ()


  • Dental implant system
Biotem IR COM OCTA PLUS ABUTMENT 4.8 mm (D) X 2.9 (Octa) X 2.0 mm(Cuff) X 6.0 mm(H)
Biotem Co., ltd
SAITB4826C
In Commercial Distribution

  • 08800036204166 ()


  • Dental implant system
Rapid Response Multi Drug Test Panels (COC/THC/AMP/OPI) - 25 tests/ kit are for the qualitative detection of Amphetamine, Opiates, THC and Cocaine metabolites in urine.
BTNX Inc
D4.1-1P29-25
In Commercial Distribution

  • 00722066000793 ()
  • 00722066003985 ()
D4.1-1P29-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA Single Test Dip card, 25Pcs/Box; First Sign for Hemosure THC
HEMOSURE INC.
FSCWTH-25
In Commercial Distribution

  • 00857338006576 ()
  • 00841824101821 ()
FSCWTH-25

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
5 Multi Drug Test Panel ( AMP1000 • COC 300 • OPI2000 •THC 50 • PCP25)
IDUN SOLUTIONS LLC
21505040010308-C
In Commercial Distribution

  • 00857275007568 ()
  • 00857275007483 ()


  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Morphine/morphine metabolite IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Amphetamine-specific IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Card, (COC/THC)+(MET1000/OPI2000)+BZO+MTD+PCP
Instant Tech Subsidiary Acquisition
PSD-7MPB
Not in Commercial Distribution

  • 00858998006890 ()
PSD-7MPB

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Card, (BZO/BAR)+(MET1000/OPI2000)+AMP+COC+THC
Instant Tech Subsidiary Acquisition
PSD-7M
Not in Commercial Distribution

  • 00858998006876 ()
PSD-7M

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Card, (COC/THC)+AMP+BZO+BUP+OPI300+OXY
Instant Tech Subsidiary Acquisition
PSD-7BUPO-300
Not in Commercial Distribution

  • 00858998006869 ()
PSD-7BUPO-300

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC, COC, OPI300, MTD, OXY drugs of abuse test cup (CLIA WAIVED)
NEXSCREEN, LLC
C-60511N
In Commercial Distribution

  • 00858984006095 ()
C-60511N

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Card, (BZO/BAR)+(MET1000/OPI2000)+COC+OXY+THC
Instant Tech Subsidiary Acquisition
PSD-7MO
Not in Commercial Distribution

  • 00858998006883 ()
PSD-7MO

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Card, (MET1000/OPI2000)+AMP+BAR+BZO+COC+THC
Instant Tech Subsidiary Acquisition
PSD-7C
Not in Commercial Distribution

  • 00858998006692 ()
PSD-7C

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Card, (MET1000/OPI2000)+BAR+BZO+COC+OXY+THC
Instant Tech Subsidiary Acquisition
PSD-7T
Not in Commercial Distribution

  • 00858998006630 ()
PSD-7T

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Cup, CLIA Waived, AMP/BZO/COC/MET1000/OPI2000/THC
Instant Tech Subsidiary Acquisition
PSCup-6MB-W
Not in Commercial Distribution

  • 00858998006524 ()
PSCup-6MB-W

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC, COC, OPI, AMP, MET, PCP, MDMA drugs of abuse test cup
NEXSCREEN, LLC
60780N
Not in Commercial Distribution

  • 00858984006026 ()
60780N

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
15 tests kit; 6-Panel Dip Card; THC/COC/OPI/AMP/MET/BZO
EASY HEALTHCARE CORPORATION
EDOAP-264
In Commercial Distribution

  • 00850253007970 ()
  • 30850253007971 ()
  • 10850253007977 ()
EDOAP-264-15

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 tests kit;6-Panel Dip Card; THC/COC/OPI/AMP/MET/BZO
EASY HEALTHCARE CORPORATION
EDOAP-264
In Commercial Distribution

  • 10850253007960 ()
  • 00850253007963 ()
  • 30850253007964 ()
EDOAP-264-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 tests kit;6-Panel Dip Card;THC/COC/OPI/AMP/MET/BZO
EASY HEALTHCARE CORPORATION
EDOAP-264
In Commercial Distribution

  • 10850253007403 ()
  • 00850253007406 ()
  • 30850253007407 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
25 tests kit;6-Panel Dip Card;THC/COC/OPI/AMP/MET/BZO
EASY HEALTHCARE CORPORATION
EDOAP-264
In Commercial Distribution

  • 10850253007397 ()
  • 00850253007390 ()
  • 30850253007391 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 tests kit; 6-Panel Dip Card; THC/COC/OPI/OXY/MET/BZO
EASY HEALTHCARE CORPORATION
EDOAP-564
In Commercial Distribution

  • 10855944007007 ()
  • 00855944007000 ()
  • 30855944007001 ()
EDOAP-564-10

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