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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STAT DOA 6 in 1 CLIA Waived Test Cup,25Pcs/Box AMP/BZO/COC/mAMP/OPI/THC
MICRO DISTRIBUTING, L.C
SCP-2167
In Commercial Distribution

  • 00816036021298 ()
  • 00816036021472 ()
SCP-2167

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT II DOA 5 in 1 CLIA Waived Test Cup, 25Pcs/Box AMP/COC/mAMP/OPI/THC
MICRO DISTRIBUTING, L.C
STATⅡ-1257
In Commercial Distribution

  • 00816036020802 ()
  • 00816036021014 ()
STATⅡ-1257

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT II DOA 5 in 1 CLIA Waived Test Cup, 25Pcs/Box BZO/COC/mAMP/OPI/THC
MICRO DISTRIBUTING, L.C
STATⅡ-6257
In Commercial Distribution

  • 00816036020796 ()
  • 00816036021007 ()
STATⅡ-6257

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT DOA 6 in 1 CLIA Waived Test Dipcard, 25Pcs/Box AMP/COC/mAMP/OPI/PCP/THC
MICRO DISTRIBUTING, L.C
SDP-164
In Commercial Distribution

  • 00816036020260 ()
  • 00816036020642 ()
SDP-164

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
ACCUTEST - 5 Drug Test Cup *CLIA-Waived* AMP (1000), COC (300), OPI (2000), PCP (25), and THC (50)
JANT PHARMACAL CORPORATION
DS86S625
In Commercial Distribution

  • 10763924086532 ()
  • 00763924086535 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 tests kit;12-Panel T-Cup;AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/TCA/THC/PCP
EASY HEALTHCARE CORPORATION
ECDOA-7124
In Commercial Distribution

  • 30810038631364 ()
  • 00810038631363 ()
  • 10810038631360 ()
ECDOA-7124-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
25 tests kit;12-Panel T-Cup;AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/TCA/THC/PCP
EASY HEALTHCARE CORPORATION
ECDOA-7124
In Commercial Distribution

  • 10810038631353 ()
  • 00810038631356 ()
  • 30810038631357 ()
ECDOA-7124-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 tests per kit;10-Panel Dip Card; AMP/BAR/BZO/COC/MTD/OPI/MET/THC/PCP/MDMA
EASY HEALTHCARE CORPORATION
EDOAP-3104
In Commercial Distribution

  • 10810038630622 ()
  • 00810038630625 ()
  • 30810038630626 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
25-pack 10 panel drug test urine cup (THC/COC/MOP/AMP/MAMP/PCP/ BAR/BZO/MTD/OXY)
IDUN SOLUTIONS LLC
12511105000034
In Commercial Distribution

  • 90857275007813 ()


  • Oxycodone IVD, kit, rapid ICT, clinical
  • Methadone IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
  • Amphetamine-specific IVD, kit, rapid ICT, clinical
  • Morphine/morphine metabolite IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
1 Test/Kit;12 Panel;AMP,BAR,BUP,BZO,COC,MDMA,MET,MOP,MTD,OXY,PCP,THC
Eterbio, Inc.
ETG004001
In Commercial Distribution

  • 06977469280011 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Tests/Kit;12 Panel;AMP,BAR,BUP,BZO,COC,MDMA,MET,MOP,MTD,OXY,PCP,THC
Eterbio, Inc.
ETG004005
In Commercial Distribution

  • 06977469280004 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
SAFElife 10-Panel T-Cup Compact; 25 per box; AMP,BUP,BZO,COC,MDMA,MET,MOP,MTD,OXY,THC
WONDFO USA CO., LTD.
DCDOA-8105-25BX-A
In Commercial Distribution

  • 10816862027362 ()
  • 00816862027365 ()
  • 00816862027358 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
SAFElife 10-Panel T-Cup Compact; 25 per box; AMP,BUP,BZO,COC,MDMA,MET,MOP,MTD,OXY,THC
WONDFO USA CO., LTD.
DCDOA-564-5BX-A
In Commercial Distribution

  • 10816862026655 ()
  • 00816862026658 ()
  • 00816862026641 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Response Multi Drug Test Panel (AMP/BAR/BZO/COC/MET/MTD/OPI/PCP/TCA/THC) - 25 tests/ kit are for qualitative detection of Amphetamine, Barbiturates, Benzodiazepines, Methadone, Opiates, Phencyclidine, Tricyclic Antidepressant, Cocaine and THC metabolites in urine.
BTNX Inc
D10.1-1P29-25
In Commercial Distribution

  • 00722066000847 ()
  • 00722066004029 ()
D10.1-1P29-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Response Multi Drug Test Panels (COC/AMP/MET/THC/MTD/OPI/OXY/BAR/BZO/BUP) - 25 tests/ kit are for the qualitative detection of Amphetamine, Methamphetamine, Methadone, Opiates, Oxycodone, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine and THC metabolites in urine.
BTNX Inc
D10.12-1P29-25
In Commercial Distribution

  • 00722066003657 ()
  • 00722066004036 ()
D10.12-1P29-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Chemtrue 10-Panel DOA Dip Card, AMP/BAR/BZO/COC/MET/MTD/OPI2000/OXY/PCP/THC, 25 tests/kit
CHEMTRON BIOTECH INC
711J10-CT
In Commercial Distribution

  • 00850019007732 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel DOA Cup Test- AMP/BAR/BUP/BZO/COC/MDMA/MET/MTD/OPI300/OXY/PCP/THC, 25tests/kit
CHEMTRON BIOTECH INC
712L01G
In Commercial Distribution

  • 00850019007671 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Lateral flow immunoassay for the detection of drugs of abuse in urine: Cocaine (COC), Methamphetamine (mAMP), Marijuana (THC),
GERMAINE LABORATORIES, INC
40325
In Commercial Distribution

  • 00695684403256 ()
  • 00695684403251 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
Lateral flow immunoassay for the detection of drugs of abuse in urine: Cocaine 300 (COC 300) & Marijuana (THC).
GERMAINE LABORATORIES, INC
40225
In Commercial Distribution

  • 00695684402259 ()
  • 00695684402251 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
THC, COC, OPI300, AMP, MET, PCP, MDMA, BAR, BZO, MTD, OXY drugs of abuse test cup (CLIA WAIVED)
Twin Spirit Inc.
C-61103D
Not in Commercial Distribution

  • 00859144006047 ()
C-61103D

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Cup, CLIA Waived, AMP/COC/MET1000/OPI2000/PCP/THC with Cr, Ni, pH, Bl, S.G.
Instant Tech Subsidiary Acquisition
PSCupA-6MP-W
Not in Commercial Distribution

  • 00858998006609 ()
PSCupA-6MP-W

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
U-Screen Squared Integrated CLIA Waived Cup 7 Panel Drug Screen for (THC/COC/OPI300/AMP/BUP/BZO/OXY)
Instant Tech Subsidiary Acquisition
USSCup-7BO CLIA
Not in Commercial Distribution

  • 00858998006050 ()
USSCup-7BO CLIA

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Cup, CLIA Waived, AMP/BZO/COC/MET1000/OPI2000/THC with Cr, Ni, pH, Bl, S.G.
Instant Tech Subsidiary Acquisition
PSCupA-6MB-W
Not in Commercial Distribution

  • 00858998006593 ()
PSCupA-6MB-W

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
2 tests kit;12-Panel Dip Card;BUP/THC/COC/MOP/MET/OXY/AMP/BAR/BZO/MTD/MDMA/PCP
EASY HEALTHCARE CORPORATION
EDOAP-6125B
In Commercial Distribution

  • 10850253007939 ()
  • 00850253007932 ()
  • 30850253007933 ()
EDOAP-6125B-2

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
25 tests kit;12 Panel-T cup; AMP/BAR/BZO/BUP/COC/MDMA/MET/MTD/MOP/OXY/THC/PCP
EASY HEALTHCARE CORPORATION
ECDOA-6125B
In Commercial Distribution

  • 10850253007588 ()
  • 00850253007581 ()
  • 30850253007582 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 tests kit;12 Panel-T cup; AMP/BAR/BZO/BUP/COC/MDMA/MET/MTD/MOP/OXY/THC/PCP
EASY HEALTHCARE CORPORATION
ECDOA-6125B
In Commercial Distribution

  • 10850253007571 ()
  • 00850253007574 ()
  • 30850253007575 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
25 tests kit;12-Panel Dip Card;BUP/THC/COC/MOP/MET/OXY/AMP/BAR/BZO/MTD/MDMA/PCP
EASY HEALTHCARE CORPORATION
EDOAP-6125B
In Commercial Distribution

  • 10850253007526 ()
  • 00850253007529 ()
  • 30850253007520 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Six Panel PreScreen Plus Cup With Adulterants (CLIA Waived) Drug Combo: AMP | BZO | COC | MET | OPI | THC +AD
MERGERS MARKETING, INC.
PSC-DOA-264AD
In Commercial Distribution

  • 10850557007499 ()
  • 00850557007492 ()
  • 00850557007485 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Eight Panel PreScreen Plus Dip Card (CLIA Waived) Drug Combo: AMP | BZO | COC | MET | MOR | MTD | OXY | THC
MERGERS MARKETING, INC.
PS-DOA-284
In Commercial Distribution

  • 00850557007201 ()
  • 00850557007218 ()
  • 10850557007215 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived Drug Test Cup (THC/COC/MOP/AMP/MET/PCP/BZO/BAR/MDMA/MTD/OXY/BUP/TCA)
Medical Disposables Corp
MDC-1135
In Commercial Distribution

  • 00851721007874 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived Drug Test Cup (THC/COC/MOP/AMP/MET/PCP/BZO/BAR/MDMA/MTD/OXY/BUP/TCA)
Medical Disposables Corp
MDC-1135
In Commercial Distribution

  • 00851721007843 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived Drug Test Cup (THC/COC/MOP/AMP/MET/PCP/BZO/BAR/MDMA/MTD/OXY/BUP/TCA)
Medical Disposables Corp
MDC-1135
In Commercial Distribution

  • 00851721007829 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
(BZO/BAR)+(COC/THC)+(MET/OPI)+(OXY/MDMA)+(PCP/AMP)+BUP+MTD with Cr, Ni, pH, Bl, S.G.
Wolfe & Associates Inc
RC12TCA
Not in Commercial Distribution

  • 00868401000254 ()
RC12TCA

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 panel drug test urine cup (THC/COC/MOP/AMP/MAMP/PCP/BAR/BZO/MTD/MDMA/OXY/BUP)
IDUN SOLUTIONS LLC
12511315000034
In Commercial Distribution

  • 00857275007797 ()


  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Buprenorphine IVD, kit, enzyme immunoassay (EIA)
  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Morphine/morphine metabolite IVD, kit, rapid ICT, clinical
  • Amphetamine-specific IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, kit, rapid ICT, clinical
  • Methadone IVD, kit, rapid ICT, clinical
  • Oxycodone IVD, kit, rapid ICT, clinical
DOA 5 in 1 Test Dip card, 25Pcs/Box; First Sign for Hemosure AMP/COC/MTD/OPI/THC
HEMOSURE INC.
FSCW4854
In Commercial Distribution

  • 00857338006880 ()
  • 00841824102781 ()
FSCW4854

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 5 in 1 Test Dip card, 25Pcs/Box; First Sign for Hemosure BZO/COC/mAMP/OPI/THC
HEMOSURE INC.
FSCW654
In Commercial Distribution

  • 00857338006422 ()
  • 00841824100367 ()
FSCW654

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 5 in 1 Test Dip card, 25Pcs/Box; First Sign for Hemosure COC/mAMP/OPI/PCP/THC
HEMOSURE INC.
FSCW354
In Commercial Distribution

  • 00857338006415 ()
  • 00841824100343 ()
FSCW354

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 5 in 1 Test Dip card, 25Pcs/Box; First Sign for Hemosure AMP/COC/mAMP/OPI/THC
HEMOSURE INC.
FSCW254
In Commercial Distribution

  • 00857338006408 ()
  • 00841824100329 ()
FSCW254

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 5 in 1 Test Dip card, 25Pcs/Box; First Sign for Hemosure AMP/COC/OPI/PCP/THC
HEMOSURE INC.
FSCW154
In Commercial Distribution

  • 00857338006392 ()
  • 00841824100312 ()
FSCW154

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 6 in 1 Test Dipcard, 25Pcs/Box; First Sign for Hemosure, AMP/COC/MTD/OPI/OXY/THC
HEMOSURE INC.
FSCW5964
In Commercial Distribution

  • 00857338006286 ()
  • 00857338006873 ()
FSCW5964

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 6 in 1 Test ECO II Cup, 25Pcs/Box, CLIA Waived, AMP500/COC150/mAMP500/OPI/PCP/THC
W.H.P.M. INC.
ECOII-7064
In Commercial Distribution

  • 00841824104549 ()
  • 00841824104556 ()
ECOII-7064P

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 6 in 1 Test ECO II Cup, 25Pcs/Box, CLIA Waived, AMP/COC/mAMP/OPI/PCP/THC
W.H.P.M. INC.
ECOII-164
In Commercial Distribution

  • 00841824104501 ()
  • 00841824104518 ()
ECOII-164P

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 6 in 1 Test ECO III Cup, 25Pcs/Box, CLIA Waived, AMP/BZO/COC/mAMP/OPI/THC
W.H.P.M. INC.
ECOIII-264
In Commercial Distribution

  • 00841824104396 ()
  • 00841824104389 ()
ECOIII-264P

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 6 in 1 Test ECO V Cup, 25Pcs/Box, CLIA Waived, AMP/COC/mAMP/MOR/PCP/THC
W.H.P.M. INC.
ECOV-3464
In Commercial Distribution

  • 00841824104372 ()
  • 00182532000250 ()
ECOV-3564P

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 6 in 1 Test ECO II Cup, 25Pcs/Box, CLIA Waived, AMP/BUP/BZO/COC/OPI/THC
W.H.P.M. INC.
ECOII-6964
In Commercial Distribution

  • 00841824104310 ()
  • 00841824104303 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 6 in 1 Test ECO II Cup, 25Pcs/Box, CLIA Waived AMP/COC/mAMP/OPI/OXY/THC
W.H.P.M. INC.
ECOII-1064
In Commercial Distribution

  • 00841824103801 ()
  • 00841824103825 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 4 in 1 Test Dip Card Cassette with Pipette, Sealed Pouch, CLIA Waived AMP/COC/OPI/THC
W.H.P.M. INC.
WDCA244
In Commercial Distribution

  • 00841824103634 ()
  • 00841824103641 ()
WDCA244

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 6 in 1 Test ECO V Cup, 25Pcs/Box, CLIA Waived AMP/BZO/COC/mAMP/OPI/THC
W.H.P.M. INC.
ECOV-264
In Commercial Distribution

  • 00841824102996 ()
  • 00841824103672 ()
ECOV-264

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 8 in 1 Test Dipcard, 25Pcs/Box Clia Waived BARB/BZO/COC/mAMP/MOR/MTD/OXY/THC
W.H.P.M. INC.
W384
In Commercial Distribution

  • 00841824102880 ()
  • 00841824100671 ()
W384

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 8 in 1 Test Dipcard, 25Pcs/Box Clia Waived AMP/BARB/BZO/COC/mAMP/OPI/PCP/THC
W.H.P.M. INC.
W184
In Commercial Distribution

  • 00841824102873 ()
  • 00841824100664 ()
W184

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