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, MTD, PCP, THC
ALFA SCIENTIFIC DESIGNS, INC.
03-3997
In Commercial Distribution

  • 10796918001464 ()
  • 00796918001467 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
INSTANT-VIEW Multi-Drugs of Abuse Urine Test AMP300, COC150, MET500, MOR300 PCP, THC, XTC w/ADU
ALFA SCIENTIFIC DESIGNS, INC.
03-3701
In Commercial Distribution

  • 10796918001242 ()
  • 00796918001245 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drug Test Cup 5 for visual qualitative detection of THC, COC, AMP, BZO and OPI300
JANT PHARMACAL CORPORATION
DS93S625
In Commercial Distribution

  • 10763924935632 ()
  • 00763924935635 ()
DS93S625

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
U-Screen Squared Integrated Cup with 5 Panel Drug Screen for (THC/COC/OPI2000/AMP/MET)
Instant Technologies, Inc.
USSCup-5M
In Commercial Distribution

USSCup-5M

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Card, (COC/THC)+(MET1000/OPI2000)+(PCP/AMP)+BAR+BZO+MDMA+MTD
Instant Technologies, Inc.
PSD-10MD
Not in Commercial Distribution

  • 00817405020881 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Card, (COC/THC)+(MET1000/OPI2000)+(OXY/MDMA)+AMP+BZO+MTD+PPX
Instant Technologies, Inc.
PSD-10MOX
Not in Commercial Distribution

  • 00817405020768 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Card, (COC/THC)+(MET1000/OPI2000)+(OXY/MDMA)+AMP+BZO+BUP+MTD
Instant Technologies, Inc.
PSD-10MOB
Not in Commercial Distribution

  • 00817405020751 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel T-Cup Compact; AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MTD,OPI,OXY,PCP,THC
WONDFO USA CO., LTD.
CDOA-6124
In Commercial Distribution

  • 10816862026471 ()
  • 00816862026474 ()
  • 00816862026467 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
13-Panel T-Cup; AMP500,BAR,BUP,BZO,COC150,mAMP500,MDMA,MOP,MTD,OXY,PCP,TCA,THC
WONDFO USA CO., LTD.
TDOA-3135
In Commercial Distribution

  • 00816862025927 ()
TDOA-3135

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel Bsure Cup; AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MOP,MTD,OXY,PCP,THC
WONDFO USA CO., LTD.
CDOA-6125
In Commercial Distribution

  • 00816862025859 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel T-Cup; BAR,BUP,BZO,COC,mAMP,MTD,OPI,OXY,TCA,THC with 3 AD*
WONDFO USA CO., LTD.
TDOA-7104A3
In Commercial Distribution

  • 00816862025309 ()
TDOA-7104A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel T-Cup; AMP,BAR,BZO,COC,mAMP,MDMA,MTD,OPI,PCP,THC with 3 AD*
WONDFO USA CO., LTD.
TDOA-3104A3
In Commercial Distribution

  • 00816862025187 ()
TDOA-3104A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
13-Panel T-Cup;AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MOP,MTD,OXY,PCP,TCA,THC
WONDFO USA CO., LTD.
TDOA-2135
In Commercial Distribution

  • 00816862025101 ()
TDOA-2135

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Prime Screen® Multi-Panel Urine Test (5-Panel Card: AMP, COC, mAMP, OPI, THC), 5T/Bo
WONDFO USA CO., LTD.
DWDOA-254-5BX-A
In Commercial Distribution

  • 10816862023982 ()
  • 00816862023985 ()
  • 00816862023992 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Prime Screen® 5-Panel T-Square with indicator; 5 per Box; AMP, COC, MET, OPI, THC
WONDFO USA CO., LTD.
DQODOA-256EUO-I-5BX-A
In Commercial Distribution

  • 10816862023906 ()
  • 00816862023909 ()
  • 00816862023916 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel T-Cup Compact;AMP500,BAR,BUP,BZO,COC150,MDMA,MET500,MOP,MTD,OXY,PCP,THC
WONDFO USA CO., LTD.
CDOA-L6125
In Commercial Distribution

  • 10816862023616 ()
  • 00816862023619 ()
  • 00816862023626 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9-Panel T-Square no THC with Indicator; AMP,BAR,COC,MDMA,MET,MTD,OPI,OXY,PCP
WONDFO USA CO., LTD.
QODOA-496NTEUO-I
In Commercial Distribution

  • 10816862023456 ()
  • 00816862023459 ()
  • 00816862023466 ()
QODOA-496NTEUO-I

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel T-Cup Compact; AMP,BAR,BUP,BZO,COC,MDMA,MTD,OPI,OXY,PCP,TCA,THC
WONDFO USA CO., LTD.
CDOA-3124
In Commercial Distribution

  • 10816862021537 ()
  • 00816862021530 ()
  • 00816862028539 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel T-Cup Compact; AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MOP,MTD,OXY,PCP,THC
WONDFO USA CO., LTD.
CDOA-6125
In Commercial Distribution

  • 00816862021219 ()
  • 00816862028218 ()
  • 10816862021216 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel Preview Cup; AMP,BAR,BZO,COC,MDMA,MET,MOP,MTD,OXY,PCP,TCA,THC
WONDFO USA CO., LTD.
PRE-PDOA-7125
In Commercial Distribution

  • 10816862021186 ()
  • 00816862021189 ()
  • 00816862028188 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel Preview Cup; AMP,BAR,BUP,BZO,COC,MDMA,MET,MOP,MTD,OXY,PCP,THC
WONDFO USA CO., LTD.
PRE-PDOA-6125
In Commercial Distribution

  • 10816862021179 ()
  • 00816862021172 ()
  • 00816862028171 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
11-Panel Dip Drug Screen (THC/COC/MOP/AMP/MET/PCP/BAR/BZO/MDMA/MTD/OXY)
WONDFO USA CO., LTD.
WD-11MT
In Commercial Distribution

  • 10816862020370 ()
  • 00816862020373 ()
  • 00816862029376 ()
WD-11MT

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel T-Cup; BAR,BUP,BZO,COC,mAMP,MTD,OPI,OXY,TCA,THC with 3 AD*
WONDFO USA CO., LTD.
TDOA-7104A3
In Commercial Distribution

  • 10816862020301 ()
  • 00816862020304 ()
  • 00816862029307 ()
TDOA-7104A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Prime Screen® 7-Panel T-Cup; 25 per box; AMP,BZO,COC,MET,OPI,OXY,THC
WONDFO USA CO., LTD.
DTDOA-274-25BX-A
In Commercial Distribution

  • 10816862024910 ()
  • 00816862024913 ()
  • 00816862024906 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel T-Cup Flat; AMP, BAR, BUP, BZO, COC, mAMP, MDMA, MOP, MTD, OXY, PCP, THC
WONDFO USA CO., LTD.
FDOA-6125
In Commercial Distribution

  • 00816862022407 ()
  • 00816862022384 ()
  • 00816862022391 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel Card for Cup; AMP,COC,mAMP,OPI,THC with 3 AD (OX,SG,pH)
WONDFO USA CO., LTD.
WDOA-254A-A3
In Commercial Distribution

  • 10816862021315 ()
  • 00816862021318 ()
  • 00816862028317 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel T-Cup; AMP,BAR,BZO,COC,mAMP,MOP,MTD,OXY,PCP,THC with 3 AD
WONDFO USA CO., LTD.
TDOA-4105A3
In Commercial Distribution

  • 10816862020998 ()
  • 00816862020991 ()
  • 00816862029994 ()
TDOA-4105A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
13-Panel T-Cup; AMP500,BAR,BUP,BZO,COC150,mAMP500,MDMA,MOP,MTD,OXY,PCP,TCA,THC
WONDFO USA CO., LTD.
TDOA-3135
In Commercial Distribution

  • 10816862020929 ()
  • 00816862020922 ()
  • 00816862025927 ()
TDOA-3135

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel T-Cup; AMP,BAR,BZO,COC,mAMP,MDMA,MTD,OPI,PCP,THC with 3 AD*
WONDFO USA CO., LTD.
TDOA-3104A3
In Commercial Distribution

  • 10816862020189 ()
  • 00816862020182 ()
  • 00816862029185 ()
TDOA-3104A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
13-Panel T-Cup;AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MOP,MTD,OXY,PCP,TCA,THC
WONDFO USA CO., LTD.
TDOA-2135
In Commercial Distribution

  • 10816862020103 ()
  • 00816862020106 ()
  • 00816862029109 ()
TDOA-2135

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
RTCII 1ST GEN THC/COC/METH/OPI300/AMP/BZO/ OXY/BAR/MTD/PCP/PPX/SVT
AMERICAN BIO MEDICA CORPORATION
10-11SPX2A-516
In Commercial Distribution

  • 10694644200482 ()
  • 10694644250487 ()
10-11SPX2A-516

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
12 Drug MINICUP OPI300/METH500/COOC150/THC/BAR/BZO/PCP/AMP500/MTD/OXY/BUP/MDMA500
AMERICAN BIO MEDICA CORPORATION
10-12BOX3-030
In Commercial Distribution

  • 10694644500278 ()
  • 10694644550273 ()
10-12BOX3-030

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
10 Panel Dip Card - CLIA - AMP/THC/COC/OPI/PCP/BZO/BARB/MTD/mAMP/OXY
CONFIRM BIOSCIENCES, INC.
CB-HE-4104
In Commercial Distribution

  • 00895330002783 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel Dip Card - CLIA COC,THC,OPI,BZO,mAMP,TCA,OXY,BUP,BAR,MTD
CONFIRM BIOSCIENCES, INC.
CB-HE-7104
In Commercial Distribution

  • 00895330002622 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel Drug Screening Test Cup AMP/BAR/BZO/COC/MET/MTD/MOP/PCP/OXY/THC
MEDICAL DISTRIBUTION GROUP INC
ID-CP10-AZ5
In Commercial Distribution

  • 20850721007352 ()
  • 10850721007355 ()
  • 00850721007358 ()
ID-CP10-AZ5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel Drug Screening Test Cup AMP/BAR/BZO/COC/MET/MTD/MOP/PCP/OXY/THC
MEDICAL DISTRIBUTION GROUP INC
ID-CP10
In Commercial Distribution

  • 20850721007307 ()
  • 10850721007300 ()
  • 00850721007303 ()
ID-CP10

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel Drug Screening Test Cup AMP/BAR/BZO/COC/MET/MTD/MOP/PCP/OXY/THC
MEDICAL DISTRIBUTION GROUP INC
ID-CP10
In Commercial Distribution

  • 20850721007260 ()
  • 10850721007263 ()
  • 00850721007266 ()
ID-CP10

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel Drug Screening Test Cup AMP/BAR/BZO/COC/MET/MTD/MOP/PCP/OXY/THC
MEDICAL DISTRIBUTION GROUP INC
ID-CP10-AZ5
In Commercial Distribution

  • 20850721007239 ()
  • 10850721007232 ()
  • 00850721007235 ()
ID-CP10-AZ5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel Drug Screening Test Cup AMP/BAR/BZO/COC/MET/MTD/MOP/PCP/OXY/THC
MEDICAL DISTRIBUTION GROUP INC
ID-CP10
In Commercial Distribution

  • 20850721007208 ()
  • 10850721007201 ()
  • 00850721007204 ()
ID-CP10

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel Drug Test Cup AMP/BAR/BZO/COC/MET/MTD/OPI/PCP/PPX/THC
UCP BIOSCIENCES, INC.
U-CUP-13104
In Commercial Distribution

  • 00817038022252 ()
  • 10817038022259 ()
  • 20817038022256 ()
U-CUP-13104

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

  • 20817038022102 ()
  • 10817038022105 ()
  • 00817038022108 ()
U-MCUP-154

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
UCP Compact Drug Test Cards 6-Panel Drug Test Card COC/OPI/MTD/BZO/OXY/THC
UCP BIOSCIENCES, INC.
U-DOA-764L
In Commercial Distribution

  • 20817038021761 ()
  • 10817038021764 ()
  • 00817038021767 ()
U-DOA-764L

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel Drug Test Cup AMP/BUP/BZO/COC/MET/MDMA/MTD/MOP/OXY/THC
UCP BIOSCIENCES, INC.
U-CUP-9104
In Commercial Distribution

  • 20817038021341 ()
  • 10817038021344 ()
  • 00817038021347 ()
U-CUP-9104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel Drug Test Cup AMP/BUP/BZO/COC/MET/MDMA/MTD/OPI/OXY/THC
UCP BIOSCIENCES, INC.
U-CUP-8104
In Commercial Distribution

  • 20817038021129 ()
  • 10817038021122 ()
  • 00817038021125 ()
U-CUP-8104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: COC / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7108-01
In Commercial Distribution

  • M90107RD7108010 ()

  • Length: 74 Millimeter
07RD7108-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: MAMP / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7061-03
In Commercial Distribution

  • M90107RD7061031 ()
  • M90107RD7061030 ()

  • Length: 75 Millimeter
07RD7061-03

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: COC / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7061-01
In Commercial Distribution

  • M90107RD7061011 ()
  • M90107RD7061010 ()

  • Length: 75 Millimeter
07RD7061-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: THC / COC
RAPID DIAGNOSTICS INC
07RD7108-01
In Commercial Distribution

  • 00817830022559 ()

  • Height: 74 Millimeter
07RD7108-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel Drug Test Cup – AMP, BZO, BUP, COC, MET, MTD, MDMA, OPI, OXY, THC
DEUS VULT, LLC
P33-10-MET
Not in Commercial Distribution

  • 00860004081661 ()
  • 00860004081654 ()
  • 00860004081647 ()
P33-10-MET

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Five Panel PreScreen Plus Mini Cup (CLIA Waived) Drug Combo: COC|AMP|MAMP|THC|OPI
MERGERS MARKETING, INC.
PSC-DOA-254M
In Commercial Distribution

  • 20851000007162 ()
  • 10851000007165 ()
  • 00851000007168 ()


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