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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6 Panel Dip Card - CLIA - COC/AMP/mAMP/THC/OPI/BZO
CONFIRM BIOSCIENCES, INC.
CB-HE-264
In Commercial Distribution

  • 00895330002653 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AccuSign® DOA 2 THC/COC card; 10 Test kit; CE
PRINCETON BIOMEDITECH CORPORATION
DOA-221-10-02
In Commercial Distribution

  • 10743816000266 ()
DOA-221-10-02

  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
AccuSign® DOA 2 THC/COC card; 35 Test kit; CE
PRINCETON BIOMEDITECH CORPORATION
DOA-221-35-02
In Commercial Distribution

  • 10743816000259 ()
DOA-221-35-02

  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, BZD, COC, MOR300, THC
ALFA SCIENTIFIC DESIGNS, INC.
03-3551
In Commercial Distribution

  • 10796918002188 ()
  • 00796918002181 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
INSTANT-VIEW Multi-Drugs of Abuse Dip Test AMP, COC, MET, MOR, THC
ALFA SCIENTIFIC DESIGNS, INC.
03-6577
In Commercial Distribution

  • 10796918001631 ()
  • 00796918001634 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
INSTANT-VIEW Multi-Drugs of Abuse Dip Test AMP, BZD, COC, MOR, THC
ALFA SCIENTIFIC DESIGNS, INC.
03-6533
In Commercial Distribution

  • 10796918001624 ()
  • 00796918001627 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
INSTANT-VIEW Multi-Drugs of Abuse Urine Test BZD, COC, MOR300, MTD, THC
ALFA SCIENTIFIC DESIGNS, INC.
03-5051
In Commercial Distribution

  • 10796918001549 ()
  • 00796918001542 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Card, (MET1000/OPI2000)+BZO+COC+OXY+THC
Instant Technologies, Inc.
PSD-6MBO
Not in Commercial Distribution

  • 00817405020720 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Card, (MET1000/OPI2000)+AMP+BZO+COC+THC
Instant Technologies, Inc.
PSD-6MB
Not in Commercial Distribution

  • 00817405020713 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
8 DRUG MINICUP THC/COC150/METH500/OPI300/BAR/BZO/PCP/AMP500
AMERICAN BIO MEDICA CORPORATION
10-8MBZ3-030
In Commercial Distribution

  • 10694644500322 ()
  • 10694644550327 ()
10-8MBZ3-030

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
Incup with AMP/BZO/BUP/COC/MTD/METH/OPI300/OXY/THC
AMERICAN BIO MEDICA CORPORATION
10-9SPC-350
In Commercial Distribution

  • 10694644400691 ()
  • 10694644450696 ()
10-9SPC-350

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
RDS bulk card with AMP/BZO/COC/METH/MDMA/OPI300/THC
AMERICAN BIO MEDICA CORPORATION
10-7SPB-258
In Commercial Distribution

  • 10694644300700 ()
  • 10694644350705 ()
10-7SPB-258

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
RTCII with THC/COC/METH/OPI300/AMP/BAR/BZO/MDMA/SVT
AMERICAN BIO MEDICA CORPORATION
10-8MZX2A-030
In Commercial Distribution

  • 10694644200468 ()
  • 10694644250463 ()
10-8MZX2A-030

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
Number One 5-Panel Drug Test Cup OPI/COC/MET/AMP/THC
UCP BIOSCIENCES, INC.
N1T-1105-P
In Commercial Distribution

  • 20817038022195 ()
  • 10817038022198 ()
  • 00817038022191 ()
N1T-1105-P

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
OEM 81-13 Drug Test 3 Panel Dip Card AMP/COC/THC
UCP BIOSCIENCES, INC.
U-DOA-134
In Commercial Distribution

  • 20817038022126 ()
  • 10817038022129 ()
  • 00817038022122 ()
U-DOA-134

  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
6-Panel Drug Test Mini Cup BZO/COC/THC/OXY/OPI300/AMP
UCP BIOSCIENCES, INC.
U-MCUP-664-POC
In Commercial Distribution

  • 20817038020740 ()
  • 10817038020743 ()
  • 00817038020746 ()
U-MCUP-664-POC

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel Drug Screening Test Cup BZO/THC/OPI300/OXY/BUP
UCP BIOSCIENCES, INC.
U-CUP-1454-RCN
In Commercial Distribution

  • 20817038020610 ()
  • 10817038020613 ()
  • 00817038020616 ()
U-CUP-1454-RCN

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6 Panel Drug Test Card COC/AMP/mAMP/THC/OPI/BZO
UCP BIOSCIENCES, INC.
U-DOA-264
In Commercial Distribution

  • 20817038020481 ()
  • 10817038020484 ()
  • 00817038020487 ()
U-DOA-264

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
One Step Drug Screen Test Card (COC/AMP/mAMP/THC/OPI)
ALERE SAN DIEGO, INC.
DOA-254
In Commercial Distribution

  • 10815845020642 ()
  • 00815845020645 ()
4012110099

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 09 COC150/AMP300/BZO/MAMP500/MDMA/OPI300/OXY/PCP/THC
REDWOOD TOXICOLOGY LABORATORY, INC.
011020181
In Commercial Distribution

  • 10858904006386 ()
  • 00858904006389 ()
DOA-194-291

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 09 COC/THC/OPI300/AMP/MAMP/PCP/BZO/OXY/BUP
REDWOOD TOXICOLOGY LABORATORY, INC.
011020180
In Commercial Distribution

  • 10858904006379 ()
  • 00858904006372 ()
DOA-194-281

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6-Panel Drug Screening Test Cup AMP/BZO/COC/MOP/OXY/THC
MEDICAL DISTRIBUTION GROUP INC
ID-CP6
In Commercial Distribution

  • 20850721007338 ()
  • 10850721007331 ()
  • 00850721007334 ()
ID-CP6

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6-Panel Drug Screening Test Cup AMP/BZO/COC/MOP/OXY/THC
MEDICAL DISTRIBUTION GROUP INC
ID-CP6-AZ5
In Commercial Distribution

  • 20850721007222 ()
  • 10850721007225 ()
  • 00850721007228 ()
ID-CP6-AZ5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6-Panel Drug Screening Test Cup AMP/BZO/COC/MOP/OXY/THC
MEDICAL DISTRIBUTION GROUP INC
ID-CP6
In Commercial Distribution

  • 20850721007130 ()
  • 10850721007133 ()
  • 00850721007136 ()
ID-CP6

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel Drug Screening Test Cup BZO/COC/THC/OPI300/OXY
MEDICAL DISTRIBUTION GROUP INC
U-CUP-1254-RCN
In Commercial Distribution

  • 20850721007109 ()
  • 10850721007102 ()
  • 00850721007105 ()
U-CUP-1254-RCN

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6-Panel Drug Screening Test Cup AMP/BZO/COC/MOP/OXY/THC
MEDICAL DISTRIBUTION GROUP INC
ID-CP6
In Commercial Distribution

  • 20850721007093 ()
  • 10850721007096 ()
  • 00850721007099 ()
ID-CP6

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Syva® RapidTest d.a.u.® 5 mAMP / OPI / COC / THC / PCP
Siemens Healthcare Diagnostics Inc.
10445360
In Commercial Distribution

  • 00842768001314 ()
  • 00630414013947 ()
6A259UL

  • 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
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
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