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, BZD, MOR2000, THC
ALFA SCIENTIFIC DESIGNS, INC.
03-3459QW
In Commercial Distribution

  • 10796918000870 ()
  • 00796918000873 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, COC, MOR2000, THC
ALFA SCIENTIFIC DESIGNS, INC.
03-3458
In Commercial Distribution

  • 10796918000863 ()
  • 00796918000866 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
INSTANT-VIEW Multi-Drugs of Abuse Urine Test BZD, COC, MET1000, THC
ALFA SCIENTIFIC DESIGNS, INC.
03-3457
In Commercial Distribution

  • 10796918000856 ()
  • 00796918000859 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
INSTANT-VIEW Multi-Drugs of Abuse Urine Test COC, MET500, MOR300, THC
ALFA SCIENTIFIC DESIGNS, INC.
03-3445
In Commercial Distribution

  • 10796918000849 ()
  • 00796918000842 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
INSTANT-VIEW Multi-Drugs of Abuse Urine Test COC, MET1000, THC, XTC
ALFA SCIENTIFIC DESIGNS, INC.
03-3438
In Commercial Distribution

  • 10796918000832 ()
  • 00796918000835 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, COC, MOR300, THC
ALFA SCIENTIFIC DESIGNS, INC.
03-3425
In Commercial Distribution

  • 10796918000818 ()
  • 00796918000811 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP, COC, THC, XTC
ALFA SCIENTIFIC DESIGNS, INC.
03-3420
In Commercial Distribution

  • 10796918000801 ()
  • 00796918000804 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
INSTANT-VIEW Multi-Drugs of Abuse Urine Test COC, MOR/OPI300, THC
ALFA SCIENTIFIC DESIGNS, INC.
03-3377
In Commercial Distribution

  • 10796918000788 ()
  • 00796918000781 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
4 Panel Home Drug Test Kit THC COC OPI MET
CONFIRM BIOSCIENCES, INC.
RO-DRC004
In Commercial Distribution

  • 00895330002370 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
INSTANT-VIEW Multi-Drugs of Abuse Urine Test COC, MET1000, MOR300, THC
ALFA SCIENTIFIC DESIGNS, INC.
03-3462
In Commercial Distribution

  • 10796918002171 ()
  • 00796918002174 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP300, COC150, MOR300, THC
ALFA SCIENTIFIC DESIGNS, INC.
03-6471
In Commercial Distribution

  • 10796918001617 ()
  • 00796918001610 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
INSTANT-VIEW Multi Drugs of Abuse Dip Test COC, OPI, THC
ALFA SCIENTIFIC DESIGNS, INC.
03-6373
In Commercial Distribution

  • 10796918001594 ()
  • 00796918001597 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Card, AMP/COC/OPI2000/PCP/THC
Instant Technologies, Inc.
PSD-5N
Not in Commercial Distribution

  • 00817405020706 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Card, AMP/COC/MET1000/OPI2000/THC
Instant Technologies, Inc.
PSD-5M
Not in Commercial Distribution

  • 00817405020690 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Cup, CLIA-Waived, AMP/COC/MET1000/OPI2000/THC
Instant Technologies, Inc.
PSCup-5M-W
Not in Commercial Distribution

  • 00817405020584 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
RTCII MINICUP THC/COC150/METH500/OPI300/BUP/OXY/MTD/MDMA500
AMERICAN BIO MEDICA CORPORATION
10-8MOX3-030
In Commercial Distribution

  • 10694644500339 ()
  • 10694644550334 ()
10-8MOX3-030

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
INCUP AMP/BAR/BZO/COC/MTD/OPI2K/PCP/TCA/THC
AMERICAN BIO MEDICA CORPORATION
10-9SPC-250
In Commercial Distribution

  • 10694644400684 ()
  • 10694644450689 ()
10-9SPC-250

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
RDS Kit with AMP/COC/MDMA/OPI300/OXY/PCP/THC
AMERICAN BIO MEDICA CORPORATION
10-7SP-307
In Commercial Distribution

  • 10694644350774 ()
  • 10694644300779 ()
10-7SP-307

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
RDS Kit AMP/BZO/COC/MDMA/METH/OPI300/PCP/THC
AMERICAN BIO MEDICA CORPORATION
10-8SP1-123
In Commercial Distribution

  • 10694644300724 ()
  • 10694644350729 ()
10-8SP1-123

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
5 Pan RDS Single Cup AMP/BAR/BZO/Opi300/THC
AMERICAN BIO MEDICA CORPORATION
10-5SP-343
In Commercial Distribution

  • 10694644300670 ()
  • 10694644350675 ()
10-5SP-343

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
5 Pan w/COC/THC/AMP/BZO/BAR pack Bulk
AMERICAN BIO MEDICA CORPORATION
10-5SPB-139
In Commercial Distribution

  • 10694644300403 ()
  • 10694644350408 ()
10-5SPB-139

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
RTCII with THC/COC/METH/OPI300/BAR/BZO/MDMA/SVT
AMERICAN BIO MEDICA CORPORATION
10-7MX2A-030
In Commercial Distribution

  • 10694644200451 ()
  • 10694644250456 ()
10-7MX2A-030

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
5 Panel Drug Test Cup AMP/COC/OPI/THC/PCP
UCP BIOSCIENCES, INC.
U-CUP-154
In Commercial Distribution

  • 20817038022287 ()
  • 10817038022280 ()
  • 00817038022283 ()
U-CUP-154

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel Drug Test Cup AMP/COC/OPI/PCP/THC
UCP BIOSCIENCES, INC.
U-CUP-154
In Commercial Distribution

  • 20817038021273 ()
  • 10817038021276 ()
  • 00817038021279 ()
U-CUP-154

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

  • 20817038021150 ()
  • 10817038021153 ()
  • 00817038021156 ()
U-DOA-264L

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel Drug Test Cup AMP/COC/MET/OPI/THC
UCP BIOSCIENCES, INC.
U-CUP-254
In Commercial Distribution

  • 20817038021112 ()
  • 10817038021115 ()
  • 00817038021118 ()
U-CUP-254

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6-Panel Drug Test Card COC/OPI/MTD/BZO/OXY/THC
UCP BIOSCIENCES, INC.
UCD-6-1-CLIA
In Commercial Distribution

  • 20817038020788 ()
  • 10817038020781 ()
  • 00817038020784 ()
UCD-6-1-CLIA

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6-Panel Drug Test Cup COC/THC/MET/OPI/ PCP/AMP
UCP BIOSCIENCES, INC.
U-CUP-264-RCLN
In Commercial Distribution

  • 20817038020696 ()
  • 10817038020699 ()
  • 00817038020692 ()
U-CUP-264-RCLN

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 08 COC/THC/OPI300/AMP/MAMP/PCP/BZO/OXY
REDWOOD TOXICOLOGY LABORATORY, INC.
011020179
In Commercial Distribution

  • 10858904006362 ()
  • 00858904006365 ()
DOA-184-521

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Panel 08 COC/ THC/AMP/MAMP/OPI2/MDMA/OXY/BZO
REDWOOD TOXICOLOGY LABORATORY, INC.
011020169
In Commercial Distribution

  • 10858904006300 ()
  • 00858904006303 ()
DOA-184-471

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel Drug Screening Test Cup BUP/BZO/MOP/OXY/THC
MEDICAL DISTRIBUTION GROUP INC
ID-CP5-BUP
In Commercial Distribution

  • 20850721007178 ()
  • 10850721007171 ()
  • 00850721007174 ()
ID-CP5-BUP

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel Drug Test Card AMP/COC/THC/MET/MOP
MEDICAL DISTRIBUTION GROUP INC
ID-CP5-DIP
In Commercial Distribution

  • 20850721007376 ()
  • 10850721007379 ()
  • 00850721007372 ()
ID-CP5-DIP

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel Drug Screening Test Cup BUP/BZO/MOP/OXY/THC
MEDICAL DISTRIBUTION GROUP INC
ID-CP5-BUP
In Commercial Distribution

  • 20850721007321 ()
  • 10850721007324 ()
  • 00850721007327 ()
ID-CP5-BUP

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel Drug Screening Test Cup THC/OXY/MOP/BZO/COC
MEDICAL DISTRIBUTION GROUP INC
ID-CP5
In Commercial Distribution

  • 20850721007161 ()
  • 10850721007164 ()
  • 00850721007167 ()
ID-CP5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
TOX/See Drug Screen Test AMP, COC, OPI, PCP, THC
BIO-RAD LABORATORIES, INC.
194-5200
In Commercial Distribution

  • 00847817000591 ()
1945200

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
TOX/See Drug Screen Test AMP, BZO, COC, OPI, THC
BIO-RAD LABORATORIES, INC.
194-5216
In Commercial Distribution

  • 00847817000379 ()
1945216

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Syva® RapidTest d.a.u.® 4 THC / OPI / COC/ mAMP
Siemens Healthcare Diagnostics Inc.
10445364
In Commercial Distribution

  • 00842768001352 ()
  • 00630414013985 ()
6A339UL

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Syva® RapidTest d.a.u.® 4 THC / OPI / COC / AMP
Siemens Healthcare Diagnostics Inc.
10445359
In Commercial Distribution

  • 00842768001307 ()
  • 00630414013923 ()
6A199UL

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
BUP10/BZO300/COC150/MOR300/OPI2000/OXY/THC/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCUPA07141 ()
  • B115ABCUPA07140 ()
ABCupA-07-14

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

  • B115ABCUPA07091 ()
  • B115ABCUPA07090 ()
ABCupA-07-09

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/BZO300/COC150/MET500/OPI2000/PCP/THC/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCUPA07071 ()
  • B115ABCUPA07070 ()
ABCupA-07-07

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/BZO300/COC150/MET500/OPI2000/OXY/THC/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCUPA07061 ()
  • B115ABCUPA07060 ()
ABCupA-07-06

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

  • B115ABCUPA07041 ()
  • B115ABCUPA07040 ()
ABCupA-07-04

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

  • B115ABCUPA07031 ()
  • B115ABCUPA07030 ()
ABCupA-07-03

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

  • B115ABCUP10201 ()
  • B115ABCUP10200 ()
ABCup-10-20

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

  • B115ABCUP10191 ()
  • B115ABCUP10190 ()
ABCup-10-19

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

  • B115ABCUP10161 ()
  • B115ABCUP10160 ()
ABCup-10-16

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

  • B115ABCUP10101 ()
  • B115ABCUP10100 ()
ABCup-10-10

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

  • B115ABCUP10091 ()
  • B115ABCUP10090 ()
ABCup-10-09

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

  • B115ABCUP10061 ()
  • B115ABCUP10060 ()
ABCup-10-06

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