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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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
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
8 Panel OralTox - AMP/COC/MET/MTD/OPI/OXY/PCP/THC
PREMIER BIOTECH, INC
OT80807
Not in Commercial Distribution

  • B313OT808071 ()
  • B313OT808070 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATSWABII saliva device, 25Pcs/Box BZO/COC/mAMP/OPI/OXY/THC
MICRO DISTRIBUTING, L.C
SWABII-368
In Commercial Distribution

  • 00816036029102 ()
  • 00816036028600 ()
SWABII-368

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATSWABII saliva device, 25Pcs/Box AMP/COC/mAMP/OPI/PCP/THC
MICRO DISTRIBUTING, L.C
SWABII-168
In Commercial Distribution

  • 00816036029096 ()
  • 00816036028594 ()
SWABII-168

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATSWAB saliva device, 25Pcs/Box AMP/COC/mAMP/OPI/PCP/THC
MICRO DISTRIBUTING, L.C
SSB-168
In Commercial Distribution

  • 00816036029041 ()
  • 00816036028549 ()
SSB-168

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATSWAB3, SS3-158 6-Panel SWAB (AMP/COC/MAMP/OPI/THC, 25Pcs/Box
MICRO DISTRIBUTING, L.C
SS3-158
In Commercial Distribution

  • 00816036028013 ()
  • 00816036027511 ()
SS3-158

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
4-Panel STATDIP CLIA WAIVED Dipcard, COC/MAMP/OPI/THC, 25Pcs/Box
MICRO DISTRIBUTING, L.C
SDP-144-0
In Commercial Distribution

  • 00816036025678 ()
  • 00816036026156 ()
SDP-144-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 tests kit;5-Panel Dip Card;AMP/BZO/COC/OPI/THC
EASY HEALTHCARE CORPORATION
EDOAP-754
In Commercial Distribution

  • 40810038636434 ()
  • 00810038636436 ()
  • 20810038636430 ()
EDOAP-754-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 tests kit;5-Panel Dip Card; AMP/BZO/COC/OPI/THC
EASY HEALTHCARE CORPORATION
EDOAP-754
In Commercial Distribution

  • 30810038631685 ()
  • 00810038631684 ()
  • 10810038631681 ()
EDOAP-754-10

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
25 tests kit;5-Panel Dip Card;AMP/BZO/COC/OPI/THC
EASY HEALTHCARE CORPORATION
EDOAP-754
In Commercial Distribution

  • 10810038631384 ()
  • 00810038631387 ()
  • 30810038631388 ()
EDOAP-754-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 tests kit;5-Panel Dip Card;AMP/BZO/COC/OPI/THC
EASY HEALTHCARE CORPORATION
EDOAP-754
In Commercial Distribution

  • 30810038630589 ()
  • 00810038630588 ()
  • 10810038630585 ()
EDOAP-754-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 tests kit;5-Panel Dip Card;THC/COC/OPI/AMP/MET
EASY HEALTHCARE CORPORATION
EDOAP-254
In Commercial Distribution

  • 30810038630572 ()
  • 00810038630571 ()
  • 10810038630578 ()
EDOAP-254-5

  • 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
5-Panel DOA Dip Card, AMP/COC/MET/OPI2000/THC, 25 tests/kit
CHEMTRON BIOTECH INC
711E04
In Commercial Distribution

  • 00850019007824 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DrugSmart Cup 6, AMP/BZO/COC/MET/OPI2K/THC, 25 tests/kit
CHEMTRON BIOTECH INC
60600D
In Commercial Distribution

  • 00850019007725 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7-Panel DOA Cup, AMP300/BZO200/COC150/MET300/OPI300/OXY/THC - 25tests/kit
CHEMTRON BIOTECH INC
712G01
In Commercial Distribution

  • 00850019007633 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
4-Panel Drug Screen Dip Card Tests, COC/THC/MET/AMP, 25pcs/kit
CHEMTRON BIOTECH INC
711D02JAJ
In Commercial Distribution

  • 00850019007565 ()
711D02JAJ

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6-Panel DOA Dip Card, THC/COC/BAR/AMP/OPI2000/MDMA, 25pcs/kit
CHEMTRON BIOTECH INC
711F03
In Commercial Distribution

  • 00850019007350 ()
711F03

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
4-Panel Drug Screen Dip Card Tests, THC/COC/MOR300/MET, 25pcs/kit
CHEMTRON BIOTECH INC
711D01
In Commercial Distribution

  • 00850019007299 ()
711D01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Chemtrue® 2-Panel Drug Screen Dip Card Tests, COC/THC, 25pcs/kit
CHEMTRON BIOTECH INC
711B01CT
In Commercial Distribution

  • 00850019007268 ()
711B01CT

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DrugSmart Dip 7 BUP/BZO/COC/MTD/MOR300/OXY/THC, 25pcs/kit
CHEMTRON BIOTECH INC
30723D
In Commercial Distribution

  • 00850019007107 ()
30723D

  • 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
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
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
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)+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, (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
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