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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RTC II cup with SVT/AMP/BZO/THC/COC/METH/OPI/BAR/MDMA in Bulk RTC II 1st Generation with SVT/AMP/BZO/THC/COC/METH/OPI/BAR/MDMA
AMERICAN BIO MEDICA CORPORATION
10-8MZX2AB-030
In Commercial Distribution

  • 10694644200475 ()
  • 10694644250470 ()
10-8MZX2AB-030

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
TOX/See Drug Screen Test AMP, BAR, BZO, COC, MTD, OPI2000, PCP, THC
BIO-RAD LABORATORIES, INC.
194-5183
In Commercial Distribution

  • 00847817000799 ()
1945183

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
TOX/See Drug Screen Test AMP, BAR, BZO, COC, MTD, OPI, PCP, THC
BIO-RAD LABORATORIES, INC.
194-5209
In Commercial Distribution

  • 00847817000607 ()
1945209

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
TOX/See Drug Screen Test AMP, BAR, BZO, COC, MET, MTD, OPI, THC
BIO-RAD LABORATORIES, INC.
194-5182
In Commercial Distribution

  • 00847817000348 ()
1945182

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7-Panel DOA Dip Card THC/COC/MOR300/AMP/MET/BZO/MDMA, 25pcs/kit
CHEMTRON BIOTECH INC
711G02JAJ
In Commercial Distribution

  • 00850019007572 ()
711G02JAJ

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel Drug Screen Dip Card Tests, AMP/COC/OPI2000/PCP/THC, 25pcs/kit
CHEMTRON BIOTECH INC
711E06
In Commercial Distribution

  • 00850019007329 ()
711E06

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel Drug Screen Dip Card Tests, AMP/COC/MET/MOR300/THC, 25pcs/kit
CHEMTRON BIOTECH INC
711E03
In Commercial Distribution

  • 00850019007305 ()
711E03

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Chemtrue® 3-Panel Drug Screen Dip Card Tests, COC/MET/THC, 25pcs/kit
CHEMTRON BIOTECH INC
711C02CT
In Commercial Distribution

  • 00850019007282 ()
711C02CT

  • Y-piece breathing circuit connector, reusable
6-Panel Drug Screen Cup Tests, AMP/BZO/COC/MET/MOR300/THC, 25pcs/kit
CHEMTRON BIOTECH INC
712F01
In Commercial Distribution

  • 00850019007039 ()
712F01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DrugSmart Cup 6 CLIA-Waived, THC/COC/OPI2K/MET/BZO/OXY, 25 tests/kit
CHEMTRON BIOTECH INC
C-60650D
In Commercial Distribution

  • 00850019007756 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
BlueRapids CLIA Waived Drug Cup; 6 Panel AMP/BZO/COC/MET/OPI2000/THC
MERCEDES MEDICAL, LLC
TNR CDOA261
In Commercial Distribution

  • 20850011007031 ()
  • 10850011007034 ()
  • 00850011007037 ()
TNR CDOA261

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Morphine/morphine metabolite IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, kit, rapid ICT, clinical
  • Amphetamine-specific IVD, kit, rapid ICT, clinical
Four Drug PreScreen Plus (CLIA Waived) Dip Card Combo: COC|MET|THC|OPI
MERGERS MARKETING, INC.
PS-DOA-144
In Commercial Distribution

  • 10851000007295 ()
  • 00851000007298 ()
  • 00851000007281 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC, COC, OPI, MET, BZO, OXY drugs of abuse test cup (CLIA WAIVED)
Twin Spirit Inc.
C-60650D
Not in Commercial Distribution

  • 00859144006009 ()
C-60650D

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel Multi-Drug Screen Test ; THC,COC,OPI,AMP,PCP (25 tests kit)
EASY HEALTHCARE CORPORATION
EDOAP-154
In Commercial Distribution

  • 10855944007632 ()
  • 00855944007635 ()
  • 30855944007636 ()
EDOAP-154-25

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

  • 00858998006913 ()
PSD-8P

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Card, (COC/THC)+AMP+BZO+BUP+MET+OPI300+OXY
Instant Tech Subsidiary Acquisition
PSD-8BUP
Not in Commercial Distribution

  • 00858998006906 ()
PSD-8BUP

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC, COC, AMP, PCP, OPI, MET drugs of abuse test cup (CLIA WAIVED)
NEXSCREEN, LLC
C-60610N
In Commercial Distribution

  • 00858984006101 ()
C-60610N

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 3 in 1 Test Dipcard, 25Pcs/Box Clia Waived AMP/MDMA/THC
W.H.P.M. INC.
W1834
In Commercial Distribution

  • 00841824102422 ()
  • 00841824100244 ()
W1834

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 3 in 1 Test Dipcard, 25Pcs/Box Clia Waived COC/OPI/THC
W.H.P.M. INC.
W134
In Commercial Distribution

  • 00841824102385 ()
  • 00841824100206 ()
W134

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 3 in 1 Test Cup, 25Pcs/Box Clia Waived AMP/OPI/THC
W.H.P.M. INC.
WCUP1434
In Commercial Distribution

  • 00841824101937 ()
  • 00841824101265 ()
WCUP1434

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 2 in 1 Test Dip Card, 25Pcs/Box, CLIA Waived MDMA/THC
W.H.P.M. INC.
W1924
In Commercial Distribution

  • 00841824104129 ()
  • 00841824104136 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 3 in 1 Test Dipcard, 25Pcs/Box Clia Waived BZO/mAMP/THC
W.H.P.M. INC.
W2334
In Commercial Distribution

  • 00841824103320 ()
  • 00841824103337 ()
W2334

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 3 in 1 Test Dipcard, 25Pcs/Box Clia Waived AMP/COC/THC
W.H.P.M. INC.
W334
In Commercial Distribution

  • 00841824102408 ()
  • 00841824100220 ()
W334

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 3 in 1 Test Dipcard, 25Pcs/Box Clia Waived COC/mAMP/THC
W.H.P.M. INC.
W234
In Commercial Distribution

  • 00841824102392 ()
  • 00841824100213 ()
W234

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

  • B115ABCUP13051 ()
  • B115ABCUP13050 ()
ABCup-13-05

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

  • B115ABCUP13011 ()
  • B115ABCUP13010 ()
ABCup-13-01

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

  • B115ABCARDA10191 ()
  • B115ABCARDA10190 ()
ABCardA-10-19

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

  • B115ABCARDA10101 ()
  • B115ABCARDA10100 ()
ABCardA-10-10

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

  • B115ABCARDA10091 ()
  • B115ABCARDA10090 ()
ABCardA-10-09

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

  • B115ABCARDA10061 ()
  • B115ABCARDA10060 ()
ABCardA-10-06

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

  • B115ABCARD13051 ()
  • B115ABCARD13050 ()
ABCard-13-05

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

  • B115ABCARDA10201 ()
  • B115ABCARDA10200 ()
ABCardA-10-20

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

  • B115ABCARDA10161 ()
  • B115ABCARDA10160 ()
ABCardA-10-16

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

  • B115ABCARD13011 ()
  • B115ABCARD13010 ()
ABCard-13-01

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

  • B115ABCUPA10201 ()
  • B115ABCUPA10200 ()
ABCupA-10-20

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

  • B115ABCUPA10161 ()
  • B115ABCUPA10160 ()
ABCupA-10-16

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

  • B115ABCUPA10101 ()
  • B115ABCUPA10100 ()
ABCupA-10-10

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

  • B115ABCUPA10091 ()
  • B115ABCUPA10090 ()
ABCupA-10-09

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

  • B115ABCUPA10191 ()
  • B115ABCUPA10190 ()
ABCupA-10-19

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

  • B115ABCUPA10061 ()
  • B115ABCUPA10060 ()
ABCupA-10-06

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Identify Diagnostics USA Drug Test Dip Card- THC (50) Cannabinoids 50 ng/ml
MEDICAL DISTRIBUTION GROUP INC
ID-US1-DIP-THC
In Commercial Distribution

  • 00850013035137 ()
  • 10850013035134 ()
ID-US1-DIP-THC

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Card, (COC/THC)+AMP+BZO+BUP+MET+OPI300+OXY
Instant Technologies, Inc.
PSD-8BUP
Not in Commercial Distribution

  • 00817405020744 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Urine Drug Screen Card for detection of Marijuana (THC) single drug, CLIA Waived
Instant Technologies, Inc.
IS1 THC-DX
In Commercial Distribution

  • 00817405020133 ()
IS1 THC-DX

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
10-Panel T-Cup Compact; AMP,BUP,BZO,COC,mAMP,MDMA,MTD,OPI,OXY,THC
WONDFO USA CO., LTD.
CDOA-8104
In Commercial Distribution

  • 10816862026556 ()
  • 00816862026559 ()
  • 00816862026542 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel Key Cup; BAR,BZO,BUP,COC,mAMP,MTD,OPI,OXY,TCA,THC
WONDFO USA CO., LTD.
KDOA-7104
In Commercial Distribution

  • 00816862025040 ()
KDOA-7104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel Key Cup; AMP,BAR,BZO,COC,mAMP,MDMA,MTD,OPI,PCP,THC
WONDFO USA CO., LTD.
KDOA-3104
In Commercial Distribution

  • 00816862025033 ()
KDOA-3104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Prime Screen® 6-Panel T-Square with indicator: AMP, COC, MET, OPI, PCP, THC
WONDFO USA CO., LTD.
DQODOA-166EUO-I-25BX-A
In Commercial Distribution

  • 10816862024187 ()
  • 00816862024180 ()
  • 00816862024197 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel Preview Cup; AMP,BUP,BZO,COC,MDMA,MET,MOP,MTD,OXY,THC
WONDFO USA CO., LTD.
PRE-PDOA-8105
In Commercial Distribution

  • 00816862021370 ()
  • 00816862028379 ()
  • 10816862021377 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel T-Cup Compact; AMP,BUP,BZO,COC,mAMP,MDMA,MOP,MTD,OXY,THC
WONDFO USA CO., LTD.
CDOA-8105
In Commercial Distribution

  • 00816862021233 ()
  • 00816862028232 ()
  • 10816862021230 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel T-Cup Compact; AMP,BUP,BZO,COC,mAMP,MDMA,MTD,OPI,OXY,THC
WONDFO USA CO., LTD.
CDOA-8104
In Commercial Distribution

  • 10816862021223 ()
  • 00816862021226 ()
  • 00816862028225 ()


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