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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Immunoassay for the detection of the following drug substance(s) in human urine: COC / M-AMP / OPI / THC
RAPID DIAGNOSTICS INC
07RD-7110-22
In Commercial Distribution

  • 00817830022818 ()

  • Length: 75 Millimeter
07RD-7110-22

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: COC / THC / OPI / M-AMP
RAPID DIAGNOSTICS INC
07RD7063-14
In Commercial Distribution

  • 00817830021217 ()

  • Length: 75 Millimeter
07RD7063-14

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BZD / BUP / OPI-II/ THC
RAPID DIAGNOSTICS INC
07RD7063-13A
In Commercial Distribution

  • 00817830021200 ()

  • Length: 75 Millimeter
07RD7063-13A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BZD / BUP / OPI / THC
RAPID DIAGNOSTICS INC
07RD7063-13
In Commercial Distribution

  • 00817830021194 ()

  • Length: 75 Millimeter
07RD7063-13

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BUP / M-AMP / OPI / THC
RAPID DIAGNOSTICS INC
07RD7110-19
In Commercial Distribution

  • 00817830020302 ()

  • Height: 74 Millimeter
07RD7110-19

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: COC / M-AMP / OPI / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7063-02
In Commercial Distribution

  • M90107RD7063021 ()
  • M90107RD7063020 ()

  • Length: 75 Millimeter
07RD7063-02

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / COC / OPI / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7063-01
In Commercial Distribution

  • M90107RD7063011 ()
  • M90107RD7063010 ()

  • Length: 75 Millimeter
07RD7063-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: COC / M-AMP / OPI / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7110-22
In Commercial Distribution

  • M90107RD7110220 ()

  • Length: 74 Millimeter
07RD7110-22

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
UScreen with 10 Panel Drug Screen for (THC/COC/OPI300/AMP/MET/BAR/BZO/MDMA/MTD/OXY)
Instant Technologies, Inc.
USSCup-10MMO300
Not in Commercial Distribution

USSCup-10MMO300

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Card, (MET1000/OPI2000)+AMP+COC+PCP+THC with Cr, Ni, pH, Bl, S.G.
Instant Technologies, Inc.
PSDA-6MP
Not in Commercial Distribution

  • 00817405020812 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Cup, CLIA Waived, AMP/COC/MET1000/OPI2000/THC with Cr, Ni, pH, Bl, S.G.
Instant Technologies, Inc.
PSCupA-5M-W
Not in Commercial Distribution

  • 00817405020591 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
14 Drug MINICUP THC/COC150/METH500/OPI300/AMP500/PCP/BZO/BAR/BUP/OXY/MTD/MDMA500/K2/ETG
AMERICAN BIO MEDICA CORPORATION
10-14BOX3KE-030
In Commercial Distribution

  • 10694644500377 ()
  • 10694644550372 ()
10-14BOX3KE-030

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
UCP Home Drug Screening Test Cups 5 Panel Drug Screening Test Cup BZO/COC/THC/OPI300/OXY
UCP BIOSCIENCES, INC.
U-CUP-1254-RCN
In Commercial Distribution

  • 20817038021587 ()
  • 10817038021580 ()
  • 00817038021583 ()
U-CUP-1254-RCN

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel Drug Test Cup AMP/BAR/BUP/BZO/COC/MET/MTD/OPI/OXY/PCP/PPX/THC
UCP BIOSCIENCES, INC.
U-CUP-4124
In Commercial Distribution

  • 20817038021303 ()
  • 10817038021306 ()
  • 00817038021309 ()
U-CUP-4124

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel Drug Test Cup AMP/BAR/BUP/BZO/COC/MET/MDMA/MTD/OPI/OXY/PCP/THC
UCP BIOSCIENCES, INC.
U-CUP-6124
In Commercial Distribution

  • 20817038021174 ()
  • 10817038021177 ()
  • 00817038021170 ()
U-CUP-6124

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel Drug Test Cup AMP/BAR/BZO/COC/MET/MDMA/MTD/MOP/OXY/PCP/TCA/THC
UCP BIOSCIENCES, INC.
U-CUP-3124
In Commercial Distribution

  • 20817038021136 ()
  • 10817038021139 ()
  • 00817038021132 ()
U-CUP-3124

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel Drug Test Cup AMP/BAR/BUP/BZO/COC/MET/MDMA/MTD/MOP/OXY/PCP/THC
UCP BIOSCIENCES, INC.
U-CUP-20124
In Commercial Distribution

  • 20817038021099 ()
  • 10817038021092 ()
  • 00817038021095 ()
U-CUP-20124

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel Drug Test Mini Cup BZO/BAR/COC/THC/MET/OPI300/MTD/OXY/MDMA/AMP/TCA/BUP
UCP BIOSCIENCES, INC.
U-MCUP-10124-POC
In Commercial Distribution

  • 20817038020757 ()
  • 10817038020750 ()
  • 00817038020753 ()
U-MCUP-10124-POC

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
13-Panel Drug Test Cup BZO/BAR/COC/THC/MET/MOP/MTD/TCA/OXY/MDMA/PCP/AMP/BUP
UCP BIOSCIENCES, INC.
U-CUP-1134-RCL
In Commercial Distribution

  • 20817038020689 ()
  • 10817038020682 ()
  • 00817038020685 ()
U-CUP-1134-RCL

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
13-Panel Drug Test Cup BZO/BAR/COC/THC/MET/MOP/MTD/TCA/OXY/MDMA/PCP/AMP/BUP
UCP BIOSCIENCES, INC.
U-CUP-1134-RCLN
In Commercial Distribution

  • 20817038020672 ()
  • 10817038020675 ()
  • 00817038020678 ()
U-CUP-1134-RCLN

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel Drug Test Card BZO/BAR/COC/THC/mAMP/MOP/MTD/TCA/OXY/MDMA/PCP/AMP
UCP BIOSCIENCES, INC.
U-DOA-3124
In Commercial Distribution

  • 20817038020498 ()
  • 10817038020491 ()
  • 00817038020494 ()
U-DOA-3124

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
"Identify® Diagnostics Drug Test Cups 6-Panel Drug Screening Test Cup AMP/BZO/COC/MOP/OXY/THC"
MEDICAL DISTRIBUTION GROUP INC
ID-CP6-AZ10
In Commercial Distribution

  • 20850721007970 ()
  • 10850721007973 ()
  • 00850721007976 ()
ID-CP6-AZ10

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

  • 20850721007802 ()
  • 10850721007805 ()
  • 00850721007808 ()
  • 30850721007809 ()
ID-CP6-AZ5

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

  • 20850721007741 ()
  • 10850721007744 ()
  • 00850721007747 ()
ID-CP6-AZ5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Identify® Diagnostics Drug Test Cards 6 Panel Drug Test Card THC/COC/MOP/OXY/MET/BZO
MEDICAL DISTRIBUTION GROUP INC
ID-CP6-DIP-AZ25
In Commercial Distribution

  • 20850721007703 ()
  • 10850721007706 ()
  • 00850721007709 ()
ID-CP6-DIP-AZ25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Identify® Diagnostics Drug Test Cards 6 Panel Drug Test Card THC/COC/MOP/OXY/MET/BZO
MEDICAL DISTRIBUTION GROUP INC
ID-CP6-DIP-AZ10
In Commercial Distribution

  • 20850721007628 ()
  • 10850721007621 ()
  • 00850721007624 ()
ID-CP6-DIP-AZ10

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Identify® Diagnostics Drug Test Cards 6 panel Drug Test Card THC/COC/MOP/OXY/MET/BZO
MEDICAL DISTRIBUTION GROUP INC
ID-CP6-DIP-AZ5
In Commercial Distribution

  • 20850721007543 ()
  • 10850721007546 ()
  • 00850721007549 ()
ID-CP6-DIP-AZ5

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

  • 20850721007512 ()
  • 10850721007515 ()
  • 00850721007518 ()
ID-CP6

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel Drug Screening Test Cup THC/COC/MOP/AMP/MET/PCP/MDMA/BAR/BZO/MTD/BUP/OXY
MEDICAL DISTRIBUTION GROUP INC
ID-CP12-AZ5
In Commercial Distribution

  • 20850721007345 ()
  • 10850721007348 ()
  • 00850721007341 ()
ID-CP12-AZ5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel Drug Screening Test Cup THC/COC/MOP/AMP/MET/PCP/MDMA/BAR/BZO/MTD/BUP/OXY
MEDICAL DISTRIBUTION GROUP INC
ID-CP12-BUP
In Commercial Distribution

  • 20850721007291 ()
  • 10850721007294 ()
  • 00850721007297 ()
ID-CP12-BUP

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel Drug Screening Test Cup THC/COC/MOP/AMP/MET/PCP/MDMA/BAR/BZO/MTD/BUP/OXY
MEDICAL DISTRIBUTION GROUP INC
ID-CP12-AZ5
In Commercial Distribution

  • 20850721007246 ()
  • 10850721007249 ()
  • 00850721007242 ()
ID-CP12-AZ5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel Drug Screening Test Cup THC/COC/MOP/AMP/MET/PCP/MDMA/BAR/BZO/MTD/BUP/OXY
MEDICAL DISTRIBUTION GROUP INC
ID-CP12-BUP
In Commercial Distribution

  • 20850721007147 ()
  • 10850721007140 ()
  • 00850721007143 ()
ID-CP12-BUP

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel Drug Screening Test Cup THC/COC/MOP/AMP/MET/PCP/MDMA/BAR/BZO/MTD/TCA/OXY
MEDICAL DISTRIBUTION GROUP INC
ID-CP12
In Commercial Distribution

  • 20850721007086 ()
  • 10850721007089 ()
  • 00850721007082 ()
ID-CP12

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel Drug Screening Test Cup THC/COC/MOP/AMP/MET/PCP/MDMA/BAR/BZO/MTD/BUP/OXY
MEDICAL DISTRIBUTION GROUP INC
ID-CP12-BUP
In Commercial Distribution

  • 20850721007062 ()
  • 10850721007065 ()
  • 00850721007068 ()
ID-CP12-BUP

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Identify® Diagnostics Drug Test Cups 6-Panel Drug Screening Test Cup AMP/BZO/COC/MOP/OXY/THC
MEDICAL DISTRIBUTION GROUP INC
ID-CP6-AZ10
In Commercial Distribution

  • 00850013035106 ()
  • 10850013035103 ()
  • 20850013035100 ()
ID-CP6-AZ10

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

  • 20850013035063 ()
  • 10850013035066 ()
  • 00850013035069 ()
ID-CP6-AZ5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
TOX/See Drug Screen Test AMP, BAR, BZO, COC, MDMA, MET, MTD, OPI, OXY, PCP, TCA, THC
BIO-RAD LABORATORIES, INC.
194-5221
In Commercial Distribution

  • 00847817000386 ()
1945221

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP/BAR/BUP/BZO/COC/MDMA/MET/MTD/PCP/PPX/OXY/TCA/THC/OPI2000/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCUPA14021 ()
  • B115ABCUPA14020 ()
ABCupA-14-02

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

  • B115ABCUPA14011 ()
  • B115ABCUPA14010 ()
ABCupA-14-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP/BAR/BUP/BZO/COC/MDMA/MAMP/MTD/PCP/PPX/OXY/TCA/THC/OPI2000/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARDA14021 ()
  • B115ABCARDA14020 ()
ABCardA-14-02

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