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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INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BZD, COC, MET1000, MOR2000, THC
ALFA SCIENTIFIC DESIGNS, INC.
03-3762
In Commercial Distribution

  • 10796918001266 ()
  • 00796918001269 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BAR, BZD, COC, MET1000, MOR2000, THC
ALFA SCIENTIFIC DESIGNS, INC.
03-3761
In Commercial Distribution

  • 10796918001259 ()
  • 00796918001252 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, COC, MET, MOR/OPI300, THC, XT
ALFA SCIENTIFIC DESIGNS, INC.
03-3627
In Commercial Distribution

  • 10796918001068 ()
  • 00796918001061 ()


  • 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
10 DRUG MINICUP THC/COC150/METH500/OPI300/AMP500/PCP/BAR/BZO/TCA/MDMA500
AMERICAN BIO MEDICA CORPORATION
10-10MBZ3TM-030
In Commercial Distribution

  • 10694644500360 ()
  • 10694644550365 ()
10-10MBZ3TM-030

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
RDS bulk pack THC/COC/OPI300/METH/MDMA/PCP/OXY/AMP/BZO/MTD
AMERICAN BIO MEDICA CORPORATION
10-10SPB-177
In Commercial Distribution

  • 10694644300731 ()
  • 10694644350736 ()
10-10SPB-177

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
DOA 2 in 1 Test Dip Card, 25Pcs/Box, CLIA Waived MDMA/THC
W.H.P.M. INC.
W1924
In Commercial Distribution

  • 00841824104129 ()
  • 00841824104136 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 3 in 1 Test Dipcard, 25Pcs/Box Clia Waived BZO/mAMP/THC
W.H.P.M. INC.
W2334
In Commercial Distribution

  • 00841824103320 ()
  • 00841824103337 ()
W2334

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 3 in 1 Test Dipcard, 25Pcs/Box Clia Waived AMP/MDMA/THC
W.H.P.M. INC.
W1834
In Commercial Distribution

  • 00841824102422 ()
  • 00841824100244 ()
W1834

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 3 in 1 Test Dipcard, 25Pcs/Box Clia Waived AMP/COC/THC
W.H.P.M. INC.
W334
In Commercial Distribution

  • 00841824102408 ()
  • 00841824100220 ()
W334

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 3 in 1 Test Dipcard, 25Pcs/Box Clia Waived COC/mAMP/THC
W.H.P.M. INC.
W234
In Commercial Distribution

  • 00841824102392 ()
  • 00841824100213 ()
W234

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 3 in 1 Test Dipcard, 25Pcs/Box Clia Waived COC/OPI/THC
W.H.P.M. INC.
W134
In Commercial Distribution

  • 00841824102385 ()
  • 00841824100206 ()
W134

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 3 in 1 Test Cup, 25Pcs/Box Clia Waived AMP/OPI/THC
W.H.P.M. INC.
WCUP1434
In Commercial Distribution

  • 00841824101937 ()
  • 00841824101265 ()
WCUP1434

  • 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
Drugs of Abuse Test Card, (COC/THC)+AMP+BZO+BUP+MET+OPI300+OXY
Instant Technologies, Inc.
PSD-8BUP
Not in Commercial Distribution

  • 00817405020744 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Urine Drug Screen Card for detection of Marijuana (THC) single drug, CLIA Waived
Instant Technologies, Inc.
IS1 THC-DX
In Commercial Distribution

  • 00817405020133 ()
IS1 THC-DX

  • Cannabinoid/cannabinoid metabolite 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
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