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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10-Panel Preview Dip Card; AMP,BAR,BZO,COC,mAMP,MTD,OPI,PCP,TCA,THC
WONDFO USA CO., LTD.
PRE-WDOA-1104
In Commercial Distribution

  • 00816862021943 ()
  • 00816862021950 ()
  • 10816862021940 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel Preview Dip Card; AMP,BAR,BUP,BZO,COC,mAMP,MTD,OPI,OXY,THC
WONDFO USA CO., LTD.
PRE-WDOA-9104
In Commercial Distribution

  • 10816862021476 ()
  • 00816862021479 ()
  • 00816862028478 ()


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

  • 10816862020738 ()
  • 00816862020731 ()
  • 00816862029734 ()
WDOA-7125

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

  • 10816862020691 ()
  • 00816862020694 ()
  • 00816862029697 ()
WDOA-6125

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

  • 10816862020684 ()
  • 00816862020687 ()
  • 00816862029680 ()
WDOA-6124

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

  • 10816862020615 ()
  • 00816862020618 ()
  • 00816862029611 ()
WDOA-3124

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel Card; AMP,BAR,BZO,COC,mAMP,MDMA,MOP,MTD,OXY,PCP,PPX,THC
WONDFO USA CO., LTD.
WDOA-1125
In Commercial Distribution

  • 10816862020516 ()
  • 00816862020519 ()
  • 00816862029512 ()
WDOA-1125

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Incup with AMP/BZO/BAR/COC/MTD/METH/OPI3/OXY/PCP/BUP/THC/MDMA
AMERICAN BIO MEDICA CORPORATION
10-12SPC-350
In Commercial Distribution

  • 10694644400707 ()
  • 10694644450702 ()
10-12SPC-350

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
9 Panel Drug Test Card BZO/COC/THC/mAMP/MOP/MTD/OXY/AMP/BUP
MEDICAL DISTRIBUTION GROUP INC
U-DOA-394
In Commercial Distribution

  • 10850721007010 ()
  • 00850721007013 ()
  • 20850721007017 ()
U-DOA-394

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
OEM 81-13 Drug Test 6 Panel Test Cup AMP/COC/THC/MET/BZO/OPI
UCP BIOSCIENCES, INC.
U-CUP-264
In Commercial Distribution

  • 20817038022232 ()
  • 10817038022235 ()
  • 00817038022238 ()
U-CUP-264

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
OEM 81-13 Drug Test 6 Panel Dip Card AMP/COC/THC/MET/BZO/OPI
UCP BIOSCIENCES, INC.
U-DOA-264
In Commercial Distribution

  • 20817038022157 ()
  • 10817038022150 ()
  • 00817038022153 ()
U-DOA-264

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 panel Test Card AMP/BAR/BZO/COC/MET/MTD/OPI/OXY/PCP/THC
UCP BIOSCIENCES, INC.
U-DOA-4104L
In Commercial Distribution

  • 20817038021167 ()
  • 10817038021160 ()
  • 00817038021163 ()
U-DOA-4104L

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel Drug Test Cup COC/THC/OPI/AMP/MET/BZO/MTD/OXY/MDMA/BUP
UCP BIOSCIENCES, INC.
UCC-10-1
In Commercial Distribution

  • 20817038021082 ()
  • 10817038021085 ()
  • 00817038021088 ()
UCC-10-1

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel Drug Test Cup COC/THC/OPI/AMP/MET/BZO/MTD/OXY/MDMA/BUP
UCP BIOSCIENCES, INC.
UCC-10-1L
In Commercial Distribution

  • 20817038021075 ()
  • 10817038021078 ()
  • 00817038021071 ()
UCC-10-1L

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel Drug Test Cup COC/THC/MOP/AMP/MET/BZO/MTD/OXY/MDMA/BUP
UCP BIOSCIENCES, INC.
UCC-10-1ML-CLIA
In Commercial Distribution

  • 20817038021037 ()
  • 10817038021030 ()
  • 00817038021033 ()
UCC-10-1ML-CLIA

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel Drug Test Cup COC/THC/MOP/AMP/MET/BZO/MTD/OXY/MDMA/BUP
UCP BIOSCIENCES, INC.
UCC-10-1ML-CLIA
In Commercial Distribution

  • 20817038020986 ()
  • 10817038020989 ()
  • 00817038020982 ()
UCC-10-1ML-CLIA

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel Drug Test Cup BZO/COC/THC/MET/MOP/MTD/OXY/MDMA/AMP/BUP
UCP BIOSCIENCES, INC.
UCC-10-1M-CLIA
In Commercial Distribution

  • 20817038020917 ()
  • 10817038020910 ()
  • 00817038020913 ()
UCC-10-1M-CLIA

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel Drug Test Cup BZO/COC/THC/MET/MOP/MTD/OXY/MDMA/AMP/BUP
UCP BIOSCIENCES, INC.
UCC-10-1M-CLIA
In Commercial Distribution

  • 20817038020887 ()
  • 10817038020880 ()
  • 00817038020883 ()
UCC-10-1M-CLIA

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel Drug Test Card COC/THC/MOP/AMP/MET/BZO/BAR/MTD/OXY/BUP
UCP BIOSCIENCES, INC.
UCD-10-2M-CLIA
In Commercial Distribution

  • 20817038020856 ()
  • 10817038020859 ()
  • 00817038020852 ()
UCD-10-2M-CLIA

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel Drug Test Card COC/THC/OPI/AMP/MET/PCP/BZO/BAR/MTD/OXY
UCP BIOSCIENCES, INC.
UCD-10-1-CLIA
In Commercial Distribution

  • 20817038020801 ()
  • 10817038020804 ()
  • 00817038020807 ()
UCD-10-1-CLIA

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA Single Test Dip card, 25Pcs/Box; First Sign for Hemosure; CLIA Waived THC
HEMOSURE INC.
FSCDIPTH-25
In Commercial Distribution

  • 00817763020837 ()
  • 00817763021544 ()
FSCDIPTH-25

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: THC
RAPID DIAGNOSTICS INC
07RD7060-10
In Commercial Distribution

  • 00817830020753 ()

  • Length: 75 Millimeter
07RD7060-10

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA WAIVED (THC/COC/OPI300/AMP/MET/PCP/BZO/BAR/MDMA/MTD/OXY/BUP)
Medical Disposables Corp
ODTC-6125
In Commercial Distribution

  • 00850041101798 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA WAIVED (THC/COC/OPI300/AMP/MET/PCP/BZO/BAR/MDMA/MTD/OXY/BUP)
Medical Disposables Corp
ODTC-6125
In Commercial Distribution

  • 00850041101781 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA WAIVED (THC/COC/OPI300/AMP/MET/PCP/BZO/BAR/MDMA/MTD/OXY/BUP)
Medical Disposables Corp
ODTC-6125
In Commercial Distribution

  • 00850041101750 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Five Panel PreScreen Plus Cup (CLIA Waived) Drug Combo: AMP | COC | OPI | PCP | THC
MERGERS MARKETING, INC.
PSC-DOA-154
In Commercial Distribution

  • 10851000007141 ()
  • 00851000007144 ()
  • 00851000007137 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Five Panel Clear Scan Drug Test Cup Drug Combo: BZO | COC | MET | MOR | THC
MERGERS MARKETING, INC.
CSC-654
In Commercial Distribution

  • 10850557007871 ()
  • 00850557007874 ()
  • 00850557007867 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Five Panel Clear Scan Drug Test Cup Drug Combo: AMP | COC | MET | OPI | THC
MERGERS MARKETING, INC.
CSC-254
In Commercial Distribution

  • 10850557007833 ()
  • 00850557007836 ()
  • 00850557007829 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Five Panel PreScreen Plus Cup (CLIA Waived) Drug Combo: BZO | COC | MET | MOR | THC
MERGERS MARKETING, INC.
PSC-DOA-654
In Commercial Distribution

  • 00850557007546 ()
  • 10850557007550 ()
  • 00850557007553 ()


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

  • 00850557007423 ()
  • 00850557007430 ()
  • 10850557007437 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
TOX/See Drug Screen Test AMP, BAR, BZO, COC, MET, OPI, PCP, TCA, THC
BIO-RAD LABORATORIES, INC.
194-5230
In Commercial Distribution

  • 00847817000393 ()
1945230

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
1 Panel urine cup that tests for THC (Marijuana) which includes a Lab Confirmation.
ALLSOURCE SCREENING SOLUTIONS, LLC
ALLTHCR
In Commercial Distribution

  • 00861272000392 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
1 Panel urine cup that tests for THC (Marijuana) which includes a Lab Confirmation.
ALLSOURCE SCREENING SOLUTIONS, LLC
ALLTHCR
In Commercial Distribution

  • 00861272000361 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
1 Panel urine cup that tests for THC (Marijuana) which includes a Lab Confirmation.
ALLSOURCE SCREENING SOLUTIONS, LLC
ALLTHCR
In Commercial Distribution

  • 00861272000309 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Card, (COC/THC)+(MET1000/OPI2000)+(PCP/AMP)+BAR+BZO+MTD
Instant Tech Subsidiary Acquisition
PSD-9CT
Not in Commercial Distribution

  • 00858998006623 ()
PSD-9CT

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Cup, (BAR/BZO)+(COC/THC)+(OXY/MDMA)+AMP+MET1000+MTD+OPI300
Instant Tech Subsidiary Acquisition
PSCup-10MMO300
Not in Commercial Distribution

  • 00858998006562 ()
PSCup-10MMO300

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Cup, (BZO/BAR)+(MET1000/OPI2000)+(PCP/AMP)+COC+MDMA+MTD+THC
Instant Tech Subsidiary Acquisition
PSCup-10M
Not in Commercial Distribution

  • 00858998006555 ()
PSCup-10M

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Cup, (BZO/BAR)+(COC/THC)+(MET/OPI)+(OXY/MDMA)+AMP+BUP
Instant Tech Subsidiary Acquisition
PSCup-10AB
Not in Commercial Distribution

  • 00858998006548 ()
PSCup-10AB

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Cup, CLIA Waived, (MET1000/OPI2000)+AMP+BAR+BZO+COC+PCP+THC
Instant Tech Subsidiary Acquisition
PSCup-8P-W
Not in Commercial Distribution

  • 00858998006531 ()
PSCup-8P-W

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
U-Screen Squared Integrated Cup 5 Panel Drug Screen for (THC/COC/OPI2000/MET/BZO)
Instant Tech Subsidiary Acquisition
USSCup-5MB
Not in Commercial Distribution

  • 00858998006043 ()
USSCup-5MB

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC/COC/OPI/AMP/MET/BZO/MTD/OXY/BUP drugs of abuse test cup
Twin Spirit Inc.
60960D
Not in Commercial Distribution

  • 00859144006153 ()
60960D

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Cup, (COC/THC)+(MET1000/OPI2000)+(PCP/AMP)+BAR+BZO+MDMA+MTD
Instant Tech Subsidiary Acquisition
PSCup-10CT
Not in Commercial Distribution

  • 00858998006975 ()
PSCup-10CT

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Card, (BZO/BAR)+(COC/THC)+(MET1000/OPI2000)+(PCP/AMP)+MTD
Instant Tech Subsidiary Acquisition
PSD-9P
Not in Commercial Distribution

  • 00858998006920 ()
PSD-9P

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Cup, (COC/THC)+(MET1000/OPI2000)+(OXY/MDMA)+AMP+BAR+BZO+BUP
Instant Tech Subsidiary Acquisition
PSCup-10BUP
Not in Commercial Distribution

  • 00858998006760 ()
PSCup-10BUP

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC, COC, OPI, AMP, MET, PCP, BZO, BAR, MTD drugs of abuse test cup
NEXSCREEN, LLC
60925N
Not in Commercial Distribution

  • 00858984006033 ()
60925N

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
8-Panel DOA Cup, BUP/BZO/COC/MET/MTD/MOR/OXY/THC, 25 tests/kit
CHEMTRON BIOTECH INC
712H01D
In Commercial Distribution

  • 00850019007985 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9-Panel DOA Cup, AMP/BZO/COC/MET/MTD/MOR300/OXY/PCP/THC, 25tests/kit
CHEMTRON BIOTECH INC
712I01
In Commercial Distribution

  • 00850019007916 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9-Panel DOA Cup, AMP/BAR/BZO/COC/MET/MTD/OPI2000/PCP/THC, 25tests/kit
CHEMTRON BIOTECH INC
KCUR920077
In Commercial Distribution

  • 00850019007886 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DrugSmart Cup 8, AMP/OPI2K/THC/COC/MET/BZO/MTD/OXY, CLIA-Waived, 25tests/kit
CHEMTRON BIOTECH INC
C-60820D
In Commercial Distribution

  • 00850019007794 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DrugSmart Cup 9, AMP/BAR/BZO/COC/MTD/OPI2K/PCP/PPX/THC, 25tests/kit
CHEMTRON BIOTECH INC
60980D
In Commercial Distribution

  • 00850019007589 ()


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