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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Immunoassay for the detection of the following drug substance(s) in human urine: COC / M-AMP / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7062-02
In Commercial Distribution

  • M90107RD7062021 ()
  • M90107RD7062020 ()

  • Length: 75 Millimeter
07RD7062-02

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

  • 00817405020775 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
u-Card TM Drug Test Screen 7 panel Test Card COC/AMP/MET/THC/OPI/BZO/OXY
UCP BIOSCIENCES, INC.
U-DOA-374L
In Commercial Distribution

  • 10817038022013 ()
  • 00817038022016 ()
  • 20817038022010 ()
U-DOA-374L

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
U-Cup TM Drug Test Screen 6 Panel Drug Test Cup THC/BZO/OXY/OPI/COC/MET
UCP BIOSCIENCES, INC.
U-CUP-564
In Commercial Distribution

  • 20817038021945 ()
  • 10817038021948 ()
  • 00817038021941 ()
U-CUP-564

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 panel Test Card AMP/BAR/BUP/BZO/COC/MET/MDMA/MTD/OPI/OXY/PCP/THC
UCP BIOSCIENCES, INC.
U-DOA-6124L
In Commercial Distribution

  • 20817038021358 ()
  • 10817038021351 ()
  • 00817038021354 ()
U-DOA-6124L

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel Drug Test Cup AMP/COC/MET/OPI/THC with Adulteration strip(S.G.,CRE, pH)
UCP BIOSCIENCES, INC.
U-DUD-254
In Commercial Distribution

  • 20817038021280 ()
  • 10817038021283 ()
  • 00817038021286 ()
U-DUD-254

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel Drug Test Cup COC/THC/MOP/AMP/MET/PCP/BZO/BAR/MTD/OXY/MDMA/BUP
UCP BIOSCIENCES, INC.
UCC-12-1ML-CLIA
In Commercial Distribution

  • 20817038021051 ()
  • 10817038021054 ()
  • 00817038021057 ()
UCC-12-1ML-CLIA

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel Drug Test Cup COC/THC/MOP/AMP/MET/PCP/BZO/BAR/MTD/OXY/MDMA/BUP
UCP BIOSCIENCES, INC.
UCC-12-1ML-CLIA
In Commercial Distribution

  • 20817038020962 ()
  • 10817038020965 ()
  • 00817038020968 ()
UCC-12-1ML-CLIA

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel Drug Test Cup COC/THC/MOP/AMP/MET/PCP/BZO/BAR/MTD/OXY/MDMA/BUP
UCP BIOSCIENCES, INC.
UCC-12-1ML-CLIA
In Commercial Distribution

  • 20817038020955 ()
  • 10817038020958 ()
  • 00817038020951 ()
UCC-12-1ML-CLIA

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel Drug Test Cup BZO/BAR/COC/THC/MET/MOP/MTD/OXY/MDMA/PCP/AMP/BUP
UCP BIOSCIENCES, INC.
UCC-12-1M-CLIA
In Commercial Distribution

  • 20817038020924 ()
  • 10817038020927 ()
  • 00817038020920 ()
UCC-12-1M-CLIA

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel Drug Test Cup BZO/BAR/COC/THC/MET/MOP/MTD/TCA/OXY/MDMA/PCP/AMP
UCP BIOSCIENCES, INC.
UCC-12-2M-CLIA
In Commercial Distribution

  • 20817038020900 ()
  • 10817038020903 ()
  • 00817038020906 ()
UCC-12-2M-CLIA

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel Drug Test Cup BZO/BAR/COC/THC/MET/MOP/MTD/OXY/MDMA/PCP/AMP/BUP
UCP BIOSCIENCES, INC.
UCC-12-1M-CLIA
In Commercial Distribution

  • 20817038020894 ()
  • 10817038020897 ()
  • 00817038020890 ()
UCC-12-1M-CLIA

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel Drug Test Card COC/THC/OPI/AMP/MET/PCP/BZO/BAR/MTD/OXY/MDMA/BUP
UCP BIOSCIENCES, INC.
UCD-12-1-CLIA
In Commercial Distribution

  • 20817038020832 ()
  • 10817038020835 ()
  • 00817038020838 ()
UCD-12-1-CLIA

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel Drug Test Card COC/THC/MOP/AMP/MET/PCP/BZO/BAR/MTD/OXY/MDMA/TCA
UCP BIOSCIENCES, INC.
UCD-12-2M-CLIA
In Commercial Distribution

  • 20817038020818 ()
  • 10817038020811 ()
  • 00817038020814 ()
UCD-12-2M-CLIA

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel Drug Test Cup AMP/BAR/BZO/BUP/COC/MDMA/MET/MTD/MOP/OXY/PCP/THC
UCP BIOSCIENCES, INC.
U-CUP-8124-RCLN
In Commercial Distribution

  • 20817038020726 ()
  • 10817038020729 ()
  • 00817038020722 ()
U-CUP-8124-RCLN

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel Drug Test Cup BZO/BAR/COC/THC/MET/MOP/MTD/OXY/MDMA/AMP/PPX/BUP
UCP BIOSCIENCES, INC.
U-CUP-2124-RCLN
In Commercial Distribution

  • 20817038020702 ()
  • 10817038020705 ()
  • 00817038020708 ()
U-CUP-2124-RCLN

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
One Step Drug Screen Test Card (COC/AMP/mAMP/THC/MTD/MDMA/OPI/PCP/BAR/BZO)
ALERE SAN DIEGO, INC.
DOA-3104
In Commercial Distribution

  • 10815845020864 ()
  • 00815845020867 ()
4026020099

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 12 COC/THC/OPI300/AMP/MAMP/PCP/BZO/BAR/MTD/MDMA/OXY/BUP WITH SVT ???
REDWOOD TOXICOLOGY LABORATORY, INC.
011020188
In Commercial Distribution

  • 10858904006430 ()
  • 00858904006433 ()
DOA-1124-081

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Identify® Diagnostics Drug Test Cards 5 Panel Drug Test Card AMP/COC/THC/MET/MOP
MEDICAL DISTRIBUTION GROUP INC
ID-CP5-DIP-AZ25
In Commercial Distribution

  • 20850721007673 ()
  • 10850721007676 ()
  • 00850721007679 ()
ID-CP5-DIP-AZ25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Identify® Diagnostics Drug Test Cups 5-Panel Drug Screening Test Cup BUP/BZO/MOP/OXY/THC
MEDICAL DISTRIBUTION GROUP INC
ID-CP5-BUP
In Commercial Distribution

  • 20850721007666 ()
  • 10850721007669 ()
  • 00850721007662 ()
ID-CP5-BUP

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Identify® Diagnostics Drug Test Cards 5 Panel Drug Test Card AMP/COC/THC/MET/MOP
MEDICAL DISTRIBUTION GROUP INC
ID-CP5-DIP-AZ10
In Commercial Distribution

  • 20850721007611 ()
  • 10850721007614 ()
  • 00850721007617 ()
ID-CP5-DIP-AZ10

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Identify ®Diagnostics Drug Test Cups 5-Panel Drug Screening Test Cup THC/OXY/MOP/BZO/COC
MEDICAL DISTRIBUTION GROUP INC
ID-CP5
In Commercial Distribution

  • 20850721007567 ()
  • 10850721007560 ()
  • 00850721007563 ()
ID-CP5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Identify® Diagnostics Drug Test Cards 5 panel Drug Test Card AMP/COC/THC/MET/MOP
MEDICAL DISTRIBUTION GROUP INC
ID-CP5-DIP-AZ5
In Commercial Distribution

  • 20850721007505 ()
  • 10850721007508 ()
  • 00850721007501 ()
ID-CP5-DIP-AZ5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel Drug Test Cup AMP/BAR/BUP/BZO/COC/EDDP/MDMA/MET/MOP/MTD/OXY/THC
MEDICAL DISTRIBUTION GROUP INC
ID-CP12-EDDP
In Commercial Distribution

  • 20850721007383 ()
  • 10850721007386 ()
  • 00850721007389 ()
ID-CP12-EDDP

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel Drug Screening Test Cup BZO/BAR/COC/THC/MET/OPI300/MTD/OXY/PCP/AMP
MEDICAL DISTRIBUTION GROUP INC
U-CUP-6104-RCN
In Commercial Distribution

  • 20850721007055 ()
  • 10850721007058 ()
  • 00850721007051 ()
U-CUP-6104-RCN

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Syva® RapidTest d.a.u.® 10 mAMP/OPI/COC/THC/PCP/BZO/BAR/MDN/TCA/AMP
Siemens Healthcare Diagnostics Inc.
10445363
In Commercial Distribution

  • 00842768001345 ()
  • 00630414013978 ()
6A289UL

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

  • B115ABCUPA13051 ()
  • B115ABCUPA13050 ()
ABCupA-13-05

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

  • B115ABCUPA13011 ()
  • B115ABCUPA13010 ()
ABCupA-13-01

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

  • B115ABCARDA13051 ()
  • B115ABCARDA13050 ()
ABCardA-13-05

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

  • B115ABCARDA13011 ()
  • B115ABCARDA13010 ()
ABCardA-13-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
13-Panel DOA Cup, AMP500/BAR/BUP/BZO/COC150/FYL5/MDMA/MET500/MTD/MOR/OXY/PCP/THC
CHEMTRON BIOTECH INC
712M09-G
In Commercial Distribution

  • 00812203030797 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DrugSmart Cup 7, AMP500/COC150/MET500/MDMA/THC/OXY/OPI + (Cr/SG/Ox)(Ni/pH/Gl)
CHEMTRON BIOTECH INC
60775D-6AB
In Commercial Distribution

  • 00812203030599 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel Cup, AMP500/BAR/BZO/COC150/MET500/MTD/OPI300/PCP/PPX/THC(Ox/pH/SG)
CHEMTRON BIOTECH INC
PCA-10X3X-ALT
In Commercial Distribution

  • 00812203030506 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel DOA Cup, AMP500/BAR/BZO/COC150/MET500/MTD/MOR/PCP/PPX/THC(Cr/Ox/pH)
CHEMTRON BIOTECH INC
712J10A-G
In Commercial Distribution

  • 00812203030254 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel DOA Cup, AMP/BAR/BZO/COC/MET/MTD/OPI300/PCP/PPX/THC(Cr/SG/Bl)
CHEMTRON BIOTECH INC
712J09A-G
In Commercial Distribution

  • 00812203030209 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
3-Panel DOA Cup, COC/THC/OPI2000/A-Strip (Cr/SG/Bl/Ni/pH/Gl), 25 tests/kit
CHEMTRON BIOTECH INC
712C04A
In Commercial Distribution

  • 00812203030001 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9-Panel STATDIP CLIA WAIVED Dipcard, AMP/BAR/BZO/COC/MAMP/MTD/OPI/PCP/THC, 25Pcs/Box
MICRO DISTRIBUTING, L.C
SDP-194-0
In Commercial Distribution

  • 00816036025821 ()
  • 00816036026309 ()
SDP-194-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP II 6 Panel CLIA Waived Test Cup, 25Pcs/Box AMP/COC/mAMP/OPI/PCP/THC
MICRO DISTRIBUTING, L.C
STATII-4267-0
In Commercial Distribution

  • 00816036025388 ()
  • 00816036025395 ()
STATII-4267-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP II 5 Panel Test Cup W/AD, AMP/COC/mAMP/OPI/THC + pH-CR-OX, 25Pcs/Box
MICRO DISTRIBUTING, L.C
STATⅡ-1257-0-A
In Commercial Distribution

  • 00816036025012 ()
  • 00816036025180 ()
STATⅡ-1257-0-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT DOA 5 in 1 CLIA Waived Test Cup, 25Pcs/Box BZO/COC/mAMP/MOR/THC
MICRO DISTRIBUTING, L.C
SCP-6157
In Commercial Distribution

  • 00816036021274 ()
  • 00816036021458 ()
SCP-6157

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

  • 00816036021250 ()
  • 00816036021434 ()
SCP-1257

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT DOA 8 in1 Test Dipcard, 25Pcs/Box BAR/BZO/COC/mAMP/MOR/MTD/OXY/THC
MICRO DISTRIBUTING, L.C
SDP-384
In Commercial Distribution

  • 00816036020314 ()
  • 00816036020703 ()
SDP-384

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT DOA 6 in1 CLIA Waived Test Dipcard, 25Pcs/Box BZO/COC/mAMP/MOR/OXY/THC
MICRO DISTRIBUTING, L.C
SDP-364
In Commercial Distribution

  • 00816036020291 ()
  • 00816036020673 ()
SDP-364

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT DOA 6 in1 CLIA Waived Test Dipcard, 25Pcs/Box AMP/BZO/COC/mAMP/MOR/THC
MICRO DISTRIBUTING, L.C
SDP-264
In Commercial Distribution

  • 00816036020284 ()
  • 00816036020666 ()
SDP-264

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT DOA 5 in1 Test Dipcard W/AD, 25Pcs/Box AMP/COC/mAMP/OPI/THC/PH-SG-OX
MICRO DISTRIBUTING, L.C
SDP-254-A
In Commercial Distribution

  • 00816036020239 ()
  • 00816036020611 ()
SDP-254-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT DOA 5 in 1 CLIA Waived Test Dipcard, 25Pcs/Box COC/BZO/mAMP/MOR/THC
MICRO DISTRIBUTING, L.C
SDP-654
In Commercial Distribution

  • 00816036020208 ()
  • 00816036020581 ()
SDP-654

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
MultiDrug Test Cup 12; AMP,BAR,BZO,COC,mAMP,MDMA,MOP,MTD,OXY,PCP,TCA, THC
JANT PHARMACAL CORPORATION
DS932
In Commercial Distribution

  • 10763924932631 ()
  • 00763924932634 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
MultiDrug Test Cup 12; AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MOP,MTD,OXY,PCP,THC
JANT PHARMACAL CORPORATION
DS930
In Commercial Distribution

  • 10763924930637 ()
  • 00763924930630 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Dip Test Card 12: AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MOP,MTD,OXY,PCP,THC.
JANT PHARMACAL CORPORATION
DS712
In Commercial Distribution

  • 10763924712639 ()
  • 00763924712632 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drug Test Cup 5 for visual qualitative detection of THC, COC, AMP, BZO, OPI300 (CLIA Waived)
JANT PHARMACAL CORPORATION
DS93S624
In Commercial Distribution

  • 10763924093639 ()
  • 00763924093632 ()
DS93S624

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