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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Rapid Response Multi Drug Test Panel (COC/AMP/MET/THC/MTD/MDMA/MOP/OXY/PPX/BAR/BZO/BUP) - 25 tests/ kit are for the qualitative detection of Amphetamine, Methamphetamine, Methadone, 3,4-Methylenedioxy-Methamphetamine, Morphine, Oxycodone, Propoxyphene, Barbiturate, Benzodiazepines, Buprenorphine, Cocaine and THC metabolites in urine.
BTNX Inc
D12.1-1P29-25
In Commercial Distribution

  • 00722066003541 ()
  • 00722066004067 ()
D12.1-1P29-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Response Multi Drug Test Panels (COC/AMP/MET/MDMA/THC/MTD/MOPI/OXY/BAR/BZO/PCP/PPX) - 25 tests/ kit are for the qualitative detection of Amphetamine, Methamphetamine, Methadone, Opiates, Oxycodone, Barbiturates, Benzodiazepines, Cocaine, THC, Phencyclidine and Propoxyphene metabolites in urine.
BTNX Inc
D12.8.1-1P29-25
In Commercial Distribution

  • 00722066005361 ()
  • 10722066005368 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 6 in 1  Test ECO II Cup, 25Pcs/Box; First Sign for Hemosure AMP/BZO/COC/mAMP/OPI/THC
HEMOSURE INC.
FSCECOII-264
In Commercial Distribution

  • 00857338006859 ()
  • 00857338006866 ()
FSCECOII-264

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 7 in 1 Test Dip card, 25Pcs/Box; First Sign for Hemosure AMP/BUP/BZO/COC/mAMP/MOR/THC
HEMOSURE INC.
FSCW2974
In Commercial Distribution

  • 00857338006781 ()
  • 00841824102026 ()
FSCW2974

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 6 in 1 Test ECO II Cup, 25Pcs/Box; First Sign for Hemosure AMP/COC/mAMP/MOR/PCP/THC
HEMOSURE INC.
FSCECOII-3464
In Commercial Distribution

  • 00857338006644 ()
  • 00857338006736 ()
FSCECOII-3464

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 6 in 1 Test ECO II Cup, 25Pcs/Box; First Sign for Hemosure BZO/COC/mAMP/OPI/OXY/THC
HEMOSURE INC.
FSCECOII-564
In Commercial Distribution

  • 00857338006637 ()
  • 00857338006729 ()
FSCECOII-564

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 7 in 1 Test Dip card, 25Pcs/Box; First Sign for Hemosure AMP/BZO/COC/mAMP/OPI/PCP/THC
HEMOSURE INC.
FSCW874
In Commercial Distribution

  • 00857338006354 ()
  • 00841824101845 ()
FSCW874

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 7 in 1 Test Dip card, 25Pcs/Box; First Sign for Hemosure AMP/BZO/COC/mAMP/OPI/OXY/THC
HEMOSURE INC.
FSCW174
In Commercial Distribution

  • 00857338006293 ()
  • 00841824102019 ()
FSCW174

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PCP/AMP/THC/COC150/MET500/BAR/BZO/OPI300/OXY/MDMA with adulteration pH/CR/OX drugs of abuse test cup
Twin Spirit Inc.
61093D-3C
Not in Commercial Distribution

  • 00859144006214 ()
61093D-3C

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Cup, (COC/THC)+(MET1000/OPI2000)+(OXY/MDMA)+(PCP/AMP)+BAR+BZO with Cr, Ni, pH, Bl, S.G.
Instant Tech Subsidiary Acquisition
PSCupA-10OM
Not in Commercial Distribution

  • 00858998006982 ()
PSCupA-10OM

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Cup, (COC/THC)+(MET1000/OPI2000)+(OXY/MDMA)+AMP+BAR+BZO+MTD With Cr, Ni, pH, Bl, S.G.
Instant Tech Subsidiary Acquisition
PSCupA-10MA
Not in Commercial Distribution

  • 00858998006272 ()
PSCupA-10MA

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
U-Screen Squared Integrated Cup with Adulterants (CR,SG,OX) 6 Panel Drug Screen for (THC/COC/OPI2000/AMP/MET/BZO)
Instant Tech Subsidiary Acquisition
USSCupA-6MB
Not in Commercial Distribution

  • 00858998006159 ()
USSCupA-6MB

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Cup, (BZO/BAR)+(COC/THC)+(MET1000/OPI2000)+(OXY/MDMA)+(PCP/AMP) with Cr, Ni, pH, Bl, S.G.
Instant Tech Subsidiary Acquisition
PSCupA-10MO
Not in Commercial Distribution

  • 00858998006661 ()
PSCupA-10MO

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Cup, (BZO/BAR)+(COC/THC)+(MET1000/OPI2000)+AMP+MTD+OXY+PPX with Cr, Ni, pH, Bl, S.G.
Instant Tech Subsidiary Acquisition
PSCupA-10MBO
Not in Commercial Distribution

  • 00858998006654 ()
PSCupA-10MBO

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Cup, (BZO/BAR)+(COC/THC)+(MET1000/OPI2000)+(OXY/MDMA)+AMP+MTD with Cr, Ni, pH, Bl, S.G.
Instant Tech Subsidiary Acquisition
PSCupA-10AM
Not in Commercial Distribution

  • 00858998006647 ()
PSCupA-10AM

  • 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) Opiates (OPI).
GERMAINE LABORATORIES, INC
40425
In Commercial Distribution

  • 00695684404253 ()
  • 00695684404251 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
Ten Panel PreScreen Plus Dip Card (CLIA Waived) Drug Combo: AMP | BAR | BZO | COC | MET | MTD | OPI | OXY | PCP | THC
MERGERS MARKETING, INC.
PS-DOA-4104
In Commercial Distribution

  • 10850557007277 ()
  • 00850557007270 ()
  • 00850557007263 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Ten Panel PreScreen Plus Dip Card (CLIA Waived) Drug Combo: AMP | BAR | BZO | COC | MDMA | MET | MTD | OPI | PCP | THC
MERGERS MARKETING, INC.
PS-DOA-3104
In Commercial Distribution

  • 10850557007239 ()
  • 00850557007232 ()
  • 00850557007225 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Ten Panel PreScreen Plus Dip Card (CLIA Waived) Drug Combo: AMP | BAR | BUP | BZO | COC | MET | MOR | MTD | OXY | THC
MERGERS MARKETING, INC.
PS-DOA-1104-051
In Commercial Distribution

  • 00850557007041 ()
  • 00850557007058 ()
  • 10850557007055 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Ten Panel PreScreen Plus Dip Card (CLIA Waived) Drug Combo: AMP | BAR | BZO | COC | MET | MTD | OPI | PCP | TCA | THC
MERGERS MARKETING, INC.
PS-DOA-1104
In Commercial Distribution

  • 00850557007027 ()
  • 00850557007034 ()
  • 10850557007031 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CSI Cup - CLIA Screen In-Vitro 6 Panel Drug Test, Click Seal Cap, AMP, BZO, COC, MET, MOP, THC, 25/BX
TRANSMED CO, LLC
CSI-CUP-265
In Commercial Distribution

  • 00850798007633 ()
  • 00850798007640 ()
  • 00850798007657 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Ten Panel PreScreen Plus Mini Cup (CLIA Waived) Drug Combo: AMP|BAR|BZO|COC300|MET500|MTD|OPI|OXY|PCP|THC
MERGERS MARKETING, INC.
PSC-DOA-4104M
In Commercial Distribution

  • 00851000007199 ()
  • 00851000007182 ()
  • 00851000007175 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
11-Panel DOA Cup, AMP/BAR/BZO/BUP/COC/MET/MTD/MOR300/OXY/PCP/THC/A-Strip (Cr/SG/Bl), 25tests/kit
CHEMTRON BIOTECH INC
712K02A
In Commercial Distribution

  • 00850019007923 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DrugSmart Cup 14 CLIA-Waived, AMP/BAR/BUP/BZO/COC/MET/MDMA/MTD/OPI300/OXY/PCP/PPX/TCA/THC, 25tests/kit
CHEMTRON BIOTECH INC
C-61403D
In Commercial Distribution

  • 00850019007657 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DrugSmart Cup 13 CLIA-Waived Test, AMP/OPI300/COC/THC/MET/PCP/BAR/BZO/MTD/MDMA/OXY/TCA/BUP, 25tests/kit
CHEMTRON BIOTECH INC
C-61313D
In Commercial Distribution

  • 00850019007626 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
OSTS 12-Panel Drug Screen Cup Tests, AMP/BAR/BUP/BZO/COC/MDMA/MET/MTD/MOR300/OXY/PCP/THC, 25pcs/kit
CHEMTRON BIOTECH INC
712L01OS
In Commercial Distribution

  • 00850019007411 ()
712L01OS

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Chemtrue® 10-Panel Drug Screen Dip Card Tests, AMP/BAR/BZO/COC/MDMA/MET/MTD/MOR300/PCP/ THC, 25pcs/kit
CHEMTRON BIOTECH INC
711J06CT
In Commercial Distribution

  • 00850019007381 ()
711J06CT

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
OSTS 12-Panel Drug Screen Cup Tests, AMP/BAR/BUP/BZO/COC/MDMA/MET/MTD/MOR300/OXY/ PCP/THC, 25pcs/kit
CHEMTRON BIOTECH INC
712L01OS
In Commercial Distribution

  • 00850019007008 ()
712L01OS

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
BluRapids CLIA Waived Drug Cup; 13 Panel AMP/BAR/BUP/BZO/COC/MET/MDMA/OPI-300/MTD/OXY/PCP/TCA/THC
MERCEDES MEDICAL, LLC
TNR CDOA2135
In Commercial Distribution

  • 00850011007105 ()
  • 10850011007102 ()
  • 20850011007109 ()
TNR CDOA2135

  • Amphetamine-specific IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Methadone IVD, kit, rapid ICT, clinical
  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
  • Morphine/morphine metabolite IVD, kit, rapid ICT, clinical
  • Oxycodone IVD, kit, rapid ICT, clinical
  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
  • Buprenorphine IVD, kit, enzyme immunoassay (EIA)
  • Tricyclic antidepressant IVD, kit, rapid ICT, clinical
  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
DOA 9 in 1 Test Dip Card, 25Pcs/Box, CLIA Waived AMP/BARB/BUP/BZO/COC/MTD/OPI/OXY/THC
W.H.P.M. INC.
W4494
In Commercial Distribution

  • 00841824105454 ()
  • 00841824105461 ()
W4494

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 7 in 1 Test Dipcard W/AD, 25Pcs/Box Clia Waived AMP/BZO/COC/mAMP/OPI/OXY/THC/PH-SG-OX
W.H.P.M. INC.
W174 W/AD
In Commercial Distribution

  • 00841824103153 ()
  • 00841824103160 ()
W174 W/AD

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 10 in 1 Test Dipcard, 25Pcs/Box, Clia Waived AMP/BARB/BUP/BZO/COC/mAMP/MTD/OPI/OXY/THC
W.H.P.M. INC.
CW12104
In Commercial Distribution

  • 00841824103054 ()
  • 00841824100824 ()
CW12104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 10 in 1 Test Dipcard, 25Pcs/Box Clia Waived AMP/BARB/BZO/COC/mAMP/MOR/MTD/OXY/PCP/THC
W.H.P.M. INC.
W6104
In Commercial Distribution

  • 00841824103030 ()
  • 00841824100817 ()
W6104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 10 in 1 Test Dipcard, 25Pcs/Box Clia Waived AMP/BARB/BZO/COC/mAMP/MDMA/MOR/MTD/OXY/THC
W.H.P.M. INC.
W14104
In Commercial Distribution

  • 00841824103009 ()
  • 00841824100787 ()
W14104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 10 in 1 Test Dipcard, 25Pcs/Box Clia Waived AMP/BARB/BZO/COC/mAMP/MTD/OPI/OXY/PCP/THC
W.H.P.M. INC.
W4104
In Commercial Distribution

  • 00841824102989 ()
  • 00841824100770 ()
W4104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 10 in 1 Test Dipcard, 25Pcs/Box Clia Waived AMP/BARB/BZO/COC/mAMP/MDMA/MTD/OPI/PCP/THC
W.H.P.M. INC.
W3104
In Commercial Distribution

  • 00841824102972 ()
  • 00841824100763 ()
W3104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 10 in 1 Test Dipcard, 25Pcs/Box Clia Waived AMP/BARB/BZO/COC/mAMP/MOR/MTD/PCP/TCA/THC
W.H.P.M. INC.
W2104
In Commercial Distribution

  • 00841824102965 ()
  • 00841824100756 ()
W2104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 10 in 1 Test Dipcard, 25Pcs/Box Clia Waived AMP/BARB/BZO/COC/mAMP/MTD/OPI/PCP/TCA/THC
W.H.P.M. INC.
W1104
In Commercial Distribution

  • 00841824102941 ()
  • 00841824100732 ()
W1104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 10 in 1 Test Dipcard, 25Pcs/Box Clia Waived AMP/BARB/BZO/COC/mAMP/MTD/OPI/OXY/PCP/THC
W.H.P.M. INC.
CW4104
In Commercial Distribution

  • 00841824102934 ()
  • 00841824100770 ()
CW4104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 10 in 1 Test Dipcard, 25Pcs/Box Clia Waived BARB/BZO/COC/mAMP/MDMA/MTD/OPI/OXY/PCP/THC
W.H.P.M. INC.
W8104
In Commercial Distribution

  • 00841824102927 ()
  • 00841824100718 ()
W8104

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