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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AYDMED Rapid Multi-Drug Test Dip Card (AMP/BZO/COC/MDMA/MTD/OPI/THC)
UCP BIOSCIENCES, INC.
DOA-3174-061
In Commercial Distribution

  • 20817038022096 ()
  • 10817038022099 ()
  • 00817038022092 ()
DOA-3174-061

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
u-CardTM Drug Test Screen 5 Panel Test Card AMP/COC/THC/MET/BZO
UCP BIOSCIENCES, INC.
U-DOA-654
In Commercial Distribution

  • 20817038022058 ()
  • 10817038022051 ()
  • 00817038022054 ()
U-DOA-654

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AIDTEQ Rapid Multi-Drug Test Dip Card (AMP/BZO/COC/MDMA/MTD/OPI/THC)
UCP BIOSCIENCES, INC.
DOA-3174-061
In Commercial Distribution

  • 10817038022020 ()
  • 00817038022023 ()
  • 20817038022027 ()
DOA-3174-061

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
u-Card Drug Test Screen 5 panel Test Card(AMP/COC/OPI/PCP/THC)
UCP BIOSCIENCES, INC.
U-DOA-154L
In Commercial Distribution

  • 20817038021853 ()
  • 10817038021856 ()
  • 00817038021859 ()
U-DOA-154L

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
8 Panel Drug Test Cup AMP/BUP/BZO/COC/MET/MOP/OXY/THC
UCP BIOSCIENCES, INC.
U-CUP-284
In Commercial Distribution

  • 10817038021337 ()
  • 00817038021330 ()
  • 20817038021334 ()
U-CUP-284

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
8 Panel Drug Test Cup AMP/BZO/COC/MET/MTD/OPI/OXY/THC
UCP BIOSCIENCES, INC.
U-CUP-184
In Commercial Distribution

  • 20817038021327 ()
  • 10817038021320 ()
  • 00817038021323 ()
U-CUP-184

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 11 COC150/AMP300/MAMP500/BAR/BZO/OPI300/MDMA/OXY/PCP/MTD/THC
REDWOOD TOXICOLOGY LABORATORY, INC.
011020187
In Commercial Distribution

  • 10858904006454 ()
  • 00858904006457 ()
DOA-1114-131

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 11 COC/THC/OPI300/AMP/MAMP/BAR/BZO/MTD/OXY/PPX/BUP
REDWOOD TOXICOLOGY LABORATORY, INC.
011020186
In Commercial Distribution

  • 10858904006447 ()
  • 00858904006440 ()
DOA-1114-121

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Identify Diagnostics USA Drug Test Dip Card- THC (50) Cannabinoids 50 ng/ml
MEDICAL DISTRIBUTION GROUP INC
ID-US1-DIP-THC
In Commercial Distribution

  • 00850013035137 ()
  • 10850013035134 ()
ID-US1-DIP-THC

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
TOX/See Drug Screen Test AMP, BAR, BZO, COC, MTD, OPI2000, PCP, THC
BIO-RAD LABORATORIES, INC.
194-5183
In Commercial Distribution

  • 00847817000799 ()
1945183

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
TOX/See Drug Screen Test AMP, BAR, BZO, COC, MTD, OPI, PCP, THC
BIO-RAD LABORATORIES, INC.
194-5209
In Commercial Distribution

  • 00847817000607 ()
1945209

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
TOX/See Drug Screen Test AMP, BAR, BZO, COC, MET, MTD, OPI, THC
BIO-RAD LABORATORIES, INC.
194-5182
In Commercial Distribution

  • 00847817000348 ()
1945182

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/BUP10/BZO300/COC150/MDMA/MET500/MOR300/MTD/OXY/THC/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCUPA10201 ()
  • B115ABCUPA10200 ()
ABCupA-10-20

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/BAR300/BZO300/COC150/MDMA/MET500/MOR300/MTD/OXY/THC/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCUPA10191 ()
  • B115ABCUPA10190 ()
ABCupA-10-19

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/BAR300/BZO300/COC150/MET500/MOR300/MTD/OXY/PCP/THC/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCUPA10161 ()
  • B115ABCUPA10160 ()
ABCupA-10-16

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
(AMP500/OPI2000)/(COC/THC)/(MET/PCP)/BAR300/BZO300/MTD/PPX/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCUPA10101 ()
  • B115ABCUPA10100 ()
ABCupA-10-10

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/BAR300/BUP10/BZO300/COC150/MET500/MOR300/MTD/OXY/THC/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCUPA10091 ()
  • B115ABCUPA10090 ()
ABCupA-10-09

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP/BAR/BZO/COC/MET/MTD/OPI/PCP/PPX/THC/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCUPA10061 ()
  • B115ABCUPA10060 ()
ABCupA-10-06

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

  • B115ABCUP13051 ()
  • B115ABCUP13050 ()
ABCup-13-05

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

  • B115ABCUP13011 ()
  • B115ABCUP13010 ()
ABCup-13-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/BUP10/BZO300/COC150/MDMA/MET500/MOR300/MTD/OXY/THC/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARDA10201 ()
  • B115ABCARDA10200 ()
ABCardA-10-20

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/BAR300/BZO300/COC150/MDMA/MET500/MOR300/MTD/OXY/THC/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARDA10191 ()
  • B115ABCARDA10190 ()
ABCardA-10-19

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/BAR300/BZO300/COC150/MET500/MOR300/MTD/OXY/PCP/THC/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARDA10161 ()
  • B115ABCARDA10160 ()
ABCardA-10-16

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
(AMP500/OPI2000)/(COC/THC)/(MET/PCP)/BAR300/BZO300/MTD/PPX/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARDA10101 ()
  • B115ABCARDA10100 ()
ABCardA-10-10

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/BAR300/BUP10/BZO300/COC150/MET500/MOR300/MTD/OXY/THC/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARDA10091 ()
  • B115ABCARDA10090 ()
ABCardA-10-09

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP/BAR/BZO/COC/MET/MTD/OPI/PCP/PPX/THC/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARDA10061 ()
  • B115ABCARDA10060 ()
ABCardA-10-06

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

  • B115ABCARD13051 ()
  • B115ABCARD13050 ()
ABCard-13-05

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

  • B115ABCARD13011 ()
  • B115ABCARD13010 ()
ABCard-13-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATSWAB saliva device, 25Pcs/Box AMP/BZO/COC/mAMP/OPI/OXY/PCP/THC
MICRO DISTRIBUTING, L.C
SSB-188
In Commercial Distribution

  • 00816036029133 ()
  • 00816036028631 ()
SSB-188

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6-Panel STATDIP CLIA WAIVED Dipcard, BUP/BZO/COC/MOR/MTD/THC, 25Pcs/Box
MICRO DISTRIBUTING, L.C
SDP-464-0
In Commercial Distribution

  • 00816036025777 ()
  • 00816036026255 ()
SDP-464-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6-Panel STATDIP CLIA WAIVED Dipcard, BZO/COC/MAMP/MOR/OXY/THC, 25Pcs/Box
MICRO DISTRIBUTING, L.C
SDP-364-0
In Commercial Distribution

  • 00816036025760 ()
  • 00816036026248 ()
SDP-364-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6-Panel STATDIP CLIA WAIVED Dipcard, BZO/AMP/COC/MAMP/MOR/THC, 25Pcs/Box
MICRO DISTRIBUTING, L.C
SDP-264-0
In Commercial Distribution

  • 00816036025753 ()
  • 00816036026231 ()
SDP-264-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6-Panel STATDIP CLIA WAIVED Dipcard, AMP/COC/MAMP/OPI/PCP/THC, 25Pcs/Box
MICRO DISTRIBUTING, L.C
SDP-164-0
In Commercial Distribution

  • 00816036025746 ()
  • 00816036026224 ()
SDP-164-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP II 5 Panel Test Cup, 25Pcs/Box BZO/COC/mAMP/MOR/THC
MICRO DISTRIBUTING, L.C
STATII-6357-0
In Commercial Distribution

  • 00816036025029 ()
  • 00816036025197 ()
STATII-6357-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP II 5 Panel Test Cup, 25Pcs/Box AMP/COC/mAMP/OPI/THC
MICRO DISTRIBUTING, L.C
STATⅡ-1257-0
In Commercial Distribution

  • 00816036025005 ()
  • 00816036025173 ()
STATⅡ-1257-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT DOA 4 in 1 Test Cassette, 25Pcs/Box COC/mAMP/MOR/THC
MICRO DISTRIBUTING, L.C
SCS-2145
In Commercial Distribution

  • 00816036020383 ()
  • 00816036020772 ()
SCS-2145

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT DOA 5 in1 Test Dipcard, 25Pcs/Box COC/mAMP/MDMA/OPI/THC
MICRO DISTRIBUTING, L.C
SDP-1554
In Commercial Distribution

  • 00816036020222 ()
  • 00816036020604 ()
SDP-1554

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT DOA 5 in1 Test Dipcard, 25Pcs/Box AMP/COC/OPI/PCP/THC
MICRO DISTRIBUTING, L.C
SDP-154
In Commercial Distribution

  • 00816036020185 ()
  • 00816036020567 ()
SDP-154

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT DOA 4 in 1 Test Dipcard, 25Pcs/Box COC/mAMP/OPI/THC
MICRO DISTRIBUTING, L.C
SDP-144
In Commercial Distribution

  • 00816036020178 ()
  • 00816036020550 ()
SDP-144

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT 3 in 1 CLIA Waived Test Dipcard, 25Pcs/Box COC/mAMP/THC
MICRO DISTRIBUTING, L.C
SDP-234
In Commercial Distribution

  • 00816036020161 ()
  • 00816036020543 ()
SDP-234

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT DOA 2 in 1 CLIA Waived Test Dipcard, 25Pcs/Box COC/THC
MICRO DISTRIBUTING, L.C
SDP-124
In Commercial Distribution

  • 00816036020154 ()
  • 00816036020536 ()
SDP-124

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Accutest MultiDrug Screen-10 (AMP/BARB/BZD/COC/MTDN/M-AMP/OPI /PCP/TCA/THC)
JANT PHARMACAL CORPORATION
DS100
In Commercial Distribution

  • 10763924100627 ()
  • 00763924100620 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
ACCUTEST Multi-Drug Screen 5-Panel Cassette Format *CLIA Waived* (MAMP, COC, THC, AMP, OPI)
JANT PHARMACAL CORPORATION
DS51
In Commercial Distribution

  • 10763924051424 ()
  • 00763924051427 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DDS 5 Test COC 300, MET 1000, OPI 300, TCA 1000, THC 50
SYNTRON BIORESEARCH, INC.
30539
In Commercial Distribution

  • 20748349000360 ()
  • 10748349000363 ()
  • 00748349000366 ()


  • Drug/toxicology screen adulteration IVD, kit, rapid spectrophotometry, clinical
No Description
Microgenics Corporation
1661086
In Commercial Distribution

  • 00884883004863 ()


  • Cannabinoid/cannabinoid metabolite IVD, control
No Description
Microgenics Corporation
1661060
In Commercial Distribution

  • 00884883004870 ()


  • Cannabinoid/cannabinoid metabolite IVD, control
No Description
Microgenics Corporation
1661078
In Commercial Distribution

  • 00884883001954 ()


  • Cannabinoid/cannabinoid metabolite IVD, control
No Description
Safecare Biotech (Hangzhou) Co., Ltd.
7 tests
In Commercial Distribution

  • 06974246461762 ()
THC-1014

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
No Description
Safecare Biotech (Hangzhou) Co., Ltd.
15 tests
In Commercial Distribution

  • 06974246461755 ()
THC-1014

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
Pointe Cannabinoids (THC) Control (18.75 ng/mL) 1 x 5 mL The Pointe Cannabinoids (THC) Controls are for use as assayed quality control materials to monitor the precision of the Pointe Cannabinoids (THC) Reagent Set (Ref# 60-CA0140-100/60-CA0140-1L) on a number of automated clinical chemistry analyzers.
POINTE SCIENTIFIC, INC.
60-TH0012-5
In Commercial Distribution

  • 00811727017314 ()
60-TH0012-5

  • Cannabinoid/cannabinoid metabolite IVD, control
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