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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7-Panel Chemtrue DOA Cup, AMP/COC/MET500/OPI300/OXY/PCP/THC + (Cr/SG/Ox)(Ni/pH/Gl)
CHEMTRON BIOTECH INC
712G07A-CT
In Commercial Distribution

  • 00812203030483 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
14-Panel DOA Cup, THC/COC150/MOR/MET500/AMP500/BZO/BAR/MTD/BUP/TCA/MDMA/OXY/PCP/PPX
CHEMTRON BIOTECH INC
PCA-14MP3-LC
In Commercial Distribution

  • 00812203030315 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
14-Panel DOA Cup, THC/COC150/MOR/MET500/AMP500/BZO/BAR/MTD/BUP/TCA/MDMA/OXY/PCP/PPX
CHEMTRON BIOTECH INC
712N04-G
In Commercial Distribution

  • 00812203030186 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DrugSmart Cup 11, THC/COC/MOR/MET/AMP/BZO/BAR/MTD/BUP/MDMA/OXY, 25 tests/kit
CHEMTRON BIOTECH INC
C-61130D
In Commercial Distribution

  • 00812203030063 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel DOA Cup, AMP/COC/MET/OPI2000/THC /A-Strip (Cr/SG/Bl/Ni/pH/Gl), 25tests/kit
CHEMTRON BIOTECH INC
712E04A
In Commercial Distribution

  • 00812203030018 ()


  • 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
AMP/BAR/BUP/BZO/COC/MDMA/MAMP/MTD/PCP/PPX/OXY/TCA/THC/OPI2000/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARDA14021 ()
  • B115ABCARDA14020 ()
ABCardA-14-02

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

  • B115ABCARDA14011 ()
  • B115ABCARDA14010 ()
ABCardA-14-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP/BAR/BUP/BZO/COC/MDMA/MET/MTD/PCP/PPX/OXY/TCA/THC/OPI2000/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCUPA14021 ()
  • B115ABCUPA14020 ()
ABCupA-14-02

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

  • B115ABCUPA14011 ()
  • B115ABCUPA14010 ()
ABCupA-14-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
"Identify® Diagnostics Drug Test Cups 6-Panel Drug Screening Test Cup AMP/BZO/COC/MOP/OXY/THC"
MEDICAL DISTRIBUTION GROUP INC
ID-CP6-AZ10
In Commercial Distribution

  • 20850721007970 ()
  • 10850721007973 ()
  • 00850721007976 ()
ID-CP6-AZ10

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Identify® Diagnostics Drug Test Cards 6 Panel Drug Test Card THC/COC/MOP/OXY/MET/BZO
MEDICAL DISTRIBUTION GROUP INC
ID-CP6-DIP-AZ25
In Commercial Distribution

  • 20850721007703 ()
  • 10850721007706 ()
  • 00850721007709 ()
ID-CP6-DIP-AZ25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Identify®Diagnostics Drug Test Cups 6-Panel Drug Screening Test Cup AMP/BZO/COC/MOP/OXY/THC
MEDICAL DISTRIBUTION GROUP INC
ID-CP6-AZ5
In Commercial Distribution

  • 20850721007802 ()
  • 10850721007805 ()
  • 00850721007808 ()
  • 30850721007809 ()
ID-CP6-AZ5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Identify®Diagnostics Drug Test Cups 6-Panel Drug Screening Test Cup AMP/BZO/COC/MOP/OXY/THC
MEDICAL DISTRIBUTION GROUP INC
ID-CP6-AZ5
In Commercial Distribution

  • 20850721007741 ()
  • 10850721007744 ()
  • 00850721007747 ()
ID-CP6-AZ5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Identify® Diagnostics Drug Test Cards 6 Panel Drug Test Card THC/COC/MOP/OXY/MET/BZO
MEDICAL DISTRIBUTION GROUP INC
ID-CP6-DIP-AZ10
In Commercial Distribution

  • 20850721007628 ()
  • 10850721007621 ()
  • 00850721007624 ()
ID-CP6-DIP-AZ10

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Identify® Diagnostics Drug Test Cups 6-Panel Drug Screening Test Cup AMP/BZO/COC/MOP/OXY/THC
MEDICAL DISTRIBUTION GROUP INC
ID-CP6-AZ10
In Commercial Distribution

  • 00850013035106 ()
  • 10850013035103 ()
  • 20850013035100 ()
ID-CP6-AZ10

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Identify® Diagnostics Drug Test Cups 6-Panel Drug Screening Test Cup AMP/BZO/COC/MOP/OXY/THC
MEDICAL DISTRIBUTION GROUP INC
ID-CP6-AZ5
In Commercial Distribution

  • 20850013035063 ()
  • 10850013035066 ()
  • 00850013035069 ()
ID-CP6-AZ5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
UScreen with 10 Panel Drug Screen for (THC/COC/OPI300/AMP/MET/BAR/BZO/MDMA/MTD/OXY)
Instant Technologies, Inc.
USSCup-10MMO300
Not in Commercial Distribution

USSCup-10MMO300

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Card, (MET1000/OPI2000)+AMP+COC+PCP+THC with Cr, Ni, pH, Bl, S.G.
Instant Technologies, Inc.
PSDA-6MP
Not in Commercial Distribution

  • 00817405020812 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Cup, CLIA Waived, AMP/COC/MET1000/OPI2000/THC with Cr, Ni, pH, Bl, S.G.
Instant Technologies, Inc.
PSCupA-5M-W
Not in Commercial Distribution

  • 00817405020591 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel T-Cup Compact; AMP,BAR,BZO,COC,mAMP,MDMA,MTD,OPI,PCP,THC with CR/pH/S.G.
WONDFO USA CO., LTD.
CDOA-3104A3
In Commercial Distribution

  • 10816862026570 ()
  • 00816862026573 ()
  • 00816862026566 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
14-Panel T-Cup Compact; AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MTD,OPI,OXY,PCP,PPX,TCA,THC
WONDFO USA CO., LTD.
CDOA-1144
In Commercial Distribution

  • 10816862026518 ()
  • 00816862026511 ()
  • 00816862026504 ()


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

  • 00816862025842 ()
TDOA-6125V

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel T-Cup; AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MOP,MTD,OXY,PCP,THC with 3 AD*
WONDFO USA CO., LTD.
TDOA-6125A3
In Commercial Distribution

  • 00816862025262 ()
TDOA-6125A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel T-Cup; AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MTD,OPI,OXY,PCP,THC with 3 AD*
WONDFO USA CO., LTD.
TDOA-6124A3
In Commercial Distribution

  • 00816862025248 ()
TDOA-6124A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel Card: AMP,BAR,BZO,COC,mAMP,MDMA,MOP,MTD,OXY,PCP,TCA,THC,5 per box
WONDFO USA CO., LTD.
DWDOA-7125-5BX-A
In Commercial Distribution

  • 10816862024439 ()
  • 00816862024432 ()
  • 00816862024449 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
14-Panel T-Cup Compact; AMP1000,BAR,BUP,BZO,COC300,EDDP,mAMP1000,MDMA,MOP,MTD,OXY,PCP,TCA,THC
WONDFO USA CO., LTD.
CDOA-2145
In Commercial Distribution

  • 10816862024200 ()
  • 00816862024203 ()
  • 00816862024210 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel T-Square with indicator; 25 per box; AMP,BAR,COC,MDMA,MET,MTD,OPI,OXY,PCP,THC
WONDFO USA CO., LTD.
DQODOA-10106EUO-I-25BX-A
In Commercial Distribution

  • 10816862023845 ()
  • 00816862023848 ()
  • 00816862023855 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
14-Panel Preview Cup; AMP, BAR, BUP, BZO, COC, EDDP, mAMP, MDMA, MTD, OPI, OXY, PCP, TCA, THC
WONDFO USA CO., LTD.
PRE-PDOA-4144
In Commercial Distribution

  • 10816862021841 ()
  • 00816862021844 ()
  • 00816862021851 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel T-Cup; AMP,BAR,BZO,COC,mAMP,MDMA,MOP,MTD,OXY,PCP,TCA,THC with 3 AD*
WONDFO USA CO., LTD.
TDOA-7125A3
In Commercial Distribution

  • 00816862025323 ()
TDOA-7125A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel T-Cup,2 per box;AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MOP,MTD,OXY,PCP,THC
WONDFO USA CO., LTD.
DTDOA-6125-2BX-A
In Commercial Distribution

  • 10816862023746 ()
  • 00816862023749 ()
  • 00816862023756 ()


  • 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 with 3AD
WONDFO USA CO., LTD.
CDOA-L6125A3
In Commercial Distribution

  • 10816862023630 ()
  • 00816862023633 ()
  • 00816862023640 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel T-Cup,2 per box;AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MOP,MTD,OXY,PCP,THC
WONDFO USA CO., LTD.
DTDOA-6125-2BX-A
In Commercial Distribution

  • 10816862023562 ()
  • 00816862023565 ()
  • 00816862023572 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 panel test cup, AMP/COC/MET1000/OPI2000/THC with Cr, Ni, pH, Bl, S.G. adulteration tests
AMEDITECH INC.
IMCA-5M
Not in Commercial Distribution

  • 00816565020229 ()
IMCA-5M

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC, COC, OPI300, AMP, MET, PCP, MDMA, BAR, BZO, MTD, TCA, OXY Drugs of Abuse Test Cup
AMEDITECH INC.
C-C1202A
Not in Commercial Distribution

  • 00816565020588 ()
C-C1202A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC, COC, OPI, AMP, MET, MDMA, BAR, BZO, MTD, OXY with Adulteration Screen for OX/SG/PH
AMEDITECH INC.
C-C1012A-3A
Not in Commercial Distribution

  • 00816565020557 ()
C-C1012A-3A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 panel test cup, AMP/COC/OPI2000/PCP/THC with Cr, Ni, pH, Bl, S.G. adulteration tests
AMEDITECH INC.
IMCA-5P
Not in Commercial Distribution

  • 00816565020236 ()
IMCA-5P

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC, COC, OPI, AMP, MET, MDMA, BAR, BZO, MTD, OXY with Adulteration Screen for OX/SG/PH
BRANAN MEDICAL CORPORATION
C-C1012A-3A
Not in Commercial Distribution

  • 00816555020260 ()
C-C1012A-3A

  • 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 with 3AD
WONDFO USA CO., LTD.
TDOA-3135A3
In Commercial Distribution

  • 10816862020912 ()
  • 00816862020915 ()
  • 00816862029918 ()
TDOA-3135A3

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

  • 10816862020844 ()
  • 00816862020847 ()
  • 00816862029840 ()
TDOA-6125V

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel T-Cup; AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MOP,MTD,OXY,PCP,THC with 3 AD*
WONDFO USA CO., LTD.
TDOA-6125A3
In Commercial Distribution

  • 10816862020264 ()
  • 00816862020267 ()
  • 00816862029260 ()
TDOA-6125A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel T-Cup; AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MTD,OPI,OXY,PCP,THC with 3 AD*
WONDFO USA CO., LTD.
TDOA-6124A3
In Commercial Distribution

  • 10816862020240 ()
  • 00816862020243 ()
  • 00816862029246 ()
TDOA-6124A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Drug Test Cup for (BZO/BAR)+(COC/THC)+(MET1000/OPI2000)+(MTD/TCA)+(OXY/MDMA)+(PCP/AMP)
Cliawaived, Inc.
CLIA-RDTC-12-02
In Commercial Distribution

  • 00816610020662 ()
CLIA-RDTC-12-02

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: COC / M-AMP / OPI / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7110-22
In Commercial Distribution

  • M90107RD7110220 ()

  • Length: 74 Millimeter
07RD7110-22

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: COC / M-AMP / OPI / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7063-02
In Commercial Distribution

  • M90107RD7063021 ()
  • M90107RD7063020 ()

  • Length: 75 Millimeter
07RD7063-02

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / COC / OPI / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7063-01
In Commercial Distribution

  • M90107RD7063011 ()
  • M90107RD7063010 ()

  • Length: 75 Millimeter
07RD7063-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: COC / M-AMP / OPI / THC
RAPID DIAGNOSTICS INC
07RD-7110-22
In Commercial Distribution

  • 00817830022818 ()

  • Length: 75 Millimeter
07RD-7110-22

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP 10 Panel Test Cup, AMP/BAR/BZO/COC/mAMP/MTD/OPI/PCP/PPX/THC), 25Pcs/Box
MICRO DISTRIBUTING, L.C
SCP-31107-0
In Commercial Distribution

  • 00816036027160 ()
  • 00816036026668 ()
SCP-31107-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP 5 Panel Test Cup w/Adulterants, BZO/COC/mAMP/MOR/THC + CR,OX,pH , 25Pcs/Box
MICRO DISTRIBUTING, L.C
SCP-6157-0-A
In Commercial Distribution

  • 00816036027092 ()
  • 00816036026590 ()
SCP-6157-0-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel STATDIP CLIA WAIVED Dipcard, AMP/BAR/BZO/COC/MAMP/MDMA/MOR/MTD/OXY/THC, 25Pcs/Box
MICRO DISTRIBUTING, L.C
SDP-9104-0
In Commercial Distribution

  • 00816036025890 ()
  • 00816036026378 ()
SDP-9104-0

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