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, 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
ACCUTEST MD-9lCOC/AMP/M-AMP/THC/MTD/OPI/PCP/BAR/BZO
JANT PHARMACAL CORPORATION
DS74AC425
In Commercial Distribution

  • 10763924074423 ()
  • 00763924074426 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
accutest MultiDrug Screen 6-panel (AMP/COC/MET/OPI/PCP/THC)
JANT PHARMACAL CORPORATION
DS60AC425
In Commercial Distribution

  • 10763924060426 ()
  • 00763924060429 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
accutest MultiDrug Screen- 5 panel (AMP/COC/MET/THC/OPI)
JANT PHARMACAL CORPORATION
DS01AC425
In Commercial Distribution

  • 10763924001429 ()
  • 00763924001422 ()


  • 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
5-Panel T-Cup; BZO,COC,mAMP,OPI,THC with 3 AD*
WONDFO USA CO., LTD.
TDOA-654A3
In Commercial Distribution

  • 00816862025286 ()
TDOA-654A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel T-Cup; AMP,COC,mAMP,OPI,THC with 3 AD*
WONDFO USA CO., LTD.
TDOA-254A3
In Commercial Distribution

  • 00816862025132 ()
TDOA-254A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7-Panel Key Cup; AMP,BZO,COC,mAMP,OPI,OXY,THC
WONDFO USA CO., LTD.
KDOA-274
In Commercial Distribution

  • 00816862025026 ()
KDOA-274

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6-Panel Card without THC; BUP,BZO,COC,MOP,MTD,OXY
WONDFO USA CO., LTD.
WDOA-865NT
In Commercial Distribution

  • 10816862023654 ()
  • 00816862023657 ()
  • 00816862023664 ()
WDOA-865NT

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6-Panel T-Square no THC; AMP,COC,MET,OPI,OXY,PCP
WONDFO USA CO., LTD.
QODOA-066NTEUO
In Commercial Distribution

  • 10816862023524 ()
  • 00816862023527 ()
  • 00816862023534 ()
QODOA-066NTEUO

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel T-Cup; BZO,COC,mAMP,OPI,THC with 3 AD*
WONDFO USA CO., LTD.
TDOA-654A3
In Commercial Distribution

  • 10816862020288 ()
  • 00816862020281 ()
  • 00816862029284 ()
TDOA-654A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
1-Panel Card; 25 per box; One Step THC Urine Test
WONDFO USA CO., LTD.
DWDTH-114-25BX-A
In Commercial Distribution

  • 10816862023760 ()
  • 00816862023763 ()
  • 00816862023770 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel Card; 5 per box; AMP,BZO,COC,OPI,THC
WONDFO USA CO., LTD.
DWDOA-754-5BX-A
In Commercial Distribution

  • 10816862023678 ()
  • 00816862023671 ()
  • 00816862023688 ()
DWDOA-754-5BX-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6-Panel T-Square with Indicator; AMP/BAR/COC/OPI/PCP/THC
WONDFO USA CO., LTD.
QODOA-966EUO-I
In Commercial Distribution

  • 10816862023371 ()
  • 00816862023374 ()
  • 00816862023381 ()
QODOA-966EUO-I

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6-Panel T-Square with indicator; AMP,COC,MET,OPI,PCP,THC
WONDFO USA CO., LTD.
QODOA-166EUO-I
In Commercial Distribution

  • 10816862022893 ()
  • 00816862022896 ()
  • 00816862022902 ()
QODOA-166EUO-I

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6-Panel T-Square with indicator; AMP,COC,MET,OPI,OXY,THC
WONDFO USA CO., LTD.
QODOA-666EUO-I
In Commercial Distribution

  • 10816862022879 ()
  • 00816862022872 ()
  • 00816862022889 ()
QODOA-666EUO-I

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7-Panel Preview Cup; AMP,BZO,COC,mAMP,OPI,OXY,THC
WONDFO USA CO., LTD.
PRE-PDOA-274
In Commercial Distribution

  • 10816862021438 ()
  • 00816862021431 ()
  • 00816862028430 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel T-Cup; AMP,COC,mAMP,OPI,THC with 3 AD*
WONDFO USA CO., LTD.
TDOA-254A3
In Commercial Distribution

  • 10816862020134 ()
  • 00816862020137 ()
  • 00816862029130 ()
TDOA-254A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7-Panel Key Cup; AMP,BZO,COC,mAMP,OPI,OXY,THC
WONDFO USA CO., LTD.
KDOA-274
In Commercial Distribution

  • 10816862020028 ()
  • 00816862020021 ()
  • 00816862029024 ()
KDOA-274

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