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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INSTANT-VIEW Multi-Drugs of Abuse Dip Test AMP, COC, THC
ALFA SCIENTIFIC DESIGNS, INC.
03-6375QW
In Commercial Distribution

  • 10796918001600 ()
  • 00796918001603 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
INSTANT-VIEW Multi Drugs of Abuse Dip Test COC, THC
ALFA SCIENTIFIC DESIGNS, INC.
03-6270QW
In Commercial Distribution

  • 10796918001570 ()
  • 00796918001573 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
INSTANT-VIEW Multi Drugs of Abuse Dip Test COC, THC
ALFA SCIENTIFIC DESIGNS, INC.
03-6270
In Commercial Distribution

  • 10796918001563 ()
  • 00796918001566 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
INSTANT-VIEW Multi Drugs of Abuse Dip Test COC150, THC
ALFA SCIENTIFIC DESIGNS, INC.
03-6260
In Commercial Distribution

  • 10796918001556 ()
  • 00796918001559 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of THC in human urine
LUMIQUICK DIAGNOSTICS, INC.
07RD7010
In Commercial Distribution

  • M90107RD70101 ()
  • M90107RD70100 ()

  • Length: 75 Millimeter
07RD7010

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of THC in human urine
LUMIQUICK DIAGNOSTICS, INC.
07RD7009
In Commercial Distribution

  • M90107RD70091 ()
  • M90107RD70090 ()

  • Length: 75 Millimeter
07RD7009

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC (Cannabinoid) 50 ng/mL 2 x 500 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
DT410
In Commercial Distribution

  • 00817302021950 ()

  • Total Volume: 46.5 Milliliter
  • Kit contains 2 R1 and 2 R2 bottles and 1 package insert
DT410

  • Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
THC (Cannabinoid) 50 ng/mL 2 x 100 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
BL410A
In Commercial Distribution

  • 00817302021752 ()

  • Kit contains 2 R1 and 2 R2 bottles and 1 package insert
  • Total Volume: 8 Milliliter
  • Total Volume: 20 Milliliter
BL410A

  • Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
THC (Cannabinoid) 50 ng/mL 2 x 100 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
MR410A
In Commercial Distribution

  • 00817302021738 ()

  • Total Volume: 20 Milliliter
  • Kit contains 2 R1 and 2 R2 bottles and 1 package insert
  • Total Volume: 10 Milliliter
MR410A

  • Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
Home Drug Test 4 Panel COC/OPI/mAMP/THC
RITE AID CORPORATION
8024510
In Commercial Distribution

  • 00011822001663 ()


  • Cocaine/cocaine metabolite IVD, reagent
  • Opiate/opiate metabolite IVD, reagent
  • Methamphetamine-specific IVD, reagent
  • Cannabinoid/cannabinoid metabolite IVD, reagent
6 DRUG MINICUP THC/COC150/METH500/OPI300/AMP500/BUP
AMERICAN BIO MEDICA CORPORATION
10-6ABX3-030
In Commercial Distribution

  • 10694644500315 ()
  • 10694644550310 ()
10-6ABX3-030

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
InCup with THC/OPI300/METH/BZO/MDMA/COC/BAR
AMERICAN BIO MEDICA CORPORATION
10-7SPC-283
In Commercial Distribution

  • 10694644450726 ()
  • 10694644400721 ()
10-7SPC-283

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
Incup with THC/COC/OPI300/METH/BAR/MDMA/SVT
AMERICAN BIO MEDICA CORPORATION
10-6SPCA-308
In Commercial Distribution

  • 10694644400714 ()
  • 10694644450719 ()
10-6SPCA-308

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
3 Pan InCup/Thc,coc,opi 2K, safe seal
AMERICAN BIO MEDICA CORPORATION
10-3OC-200-S
In Commercial Distribution

  • 10694644400639 ()
  • 10694644450634 ()
10-3OC-200-S

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
5w/AMP/COC/THC/OPI2K/BAR BULK PACK 50
AMERICAN BIO MEDICA CORPORATION
10-5SPB-110
In Commercial Distribution

  • 10694644300663 ()
  • 10694644350668 ()
10-5SPB-110

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
RDS AMP/BZO/THC/COC/MTD/OPI300/OXY/BUP
AMERICAN BIO MEDICA CORPORATION
10-8SPB-301
In Commercial Distribution

  • 10694644300632 ()
  • 10694644350637 ()
10-8SPB-301

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
5/Thc,Bzo,Mtd,Coc,Opi 3 BULK P
AMERICAN BIO MEDICA CORPORATION
10-5SPB-168
In Commercial Distribution

  • 10694644300410 ()
  • 10694644350415 ()
10-5SPB-168

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
5 panel RapidTox with THC/COC/OPI2000/AMP/BZO
AMERICAN BIO MEDICA CORPORATION
10-5ZT-200
In Commercial Distribution

  • 10694644150459 ()
  • 10694644100454 ()
10-5ZT-200

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
5 panel Test Card AMP/COC/MET/OPI/THC
UCP BIOSCIENCES, INC.
U-DOA-254L
In Commercial Distribution

  • 20817038021143 ()
  • 10817038021146 ()
  • 00817038021149 ()
U-DOA-254L

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel Drug Test Card COC/THC/OPI/AMP/BZO
UCP BIOSCIENCES, INC.
UCD-5-1-CLIA
In Commercial Distribution

  • 20817038020795 ()
  • 10817038020798 ()
  • 00817038020791 ()
UCD-5-1-CLIA

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel Drug Test Cup COC/THC/MET/OPI/AMP
UCP BIOSCIENCES, INC.
U-CUP-254-RCLN
In Commercial Distribution

  • 20817038020719 ()
  • 10817038020712 ()
  • 00817038020715 ()
U-CUP-254-RCLN

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
One Step Drug Screen Test Card (COC/mAMP/THC)
ALERE SAN DIEGO, INC.
DOA-234
In Commercial Distribution

  • 10815845020581 ()
  • 00815845020584 ()
4012090099

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC One Step Marijuana Single Drug Test (Urine) (THC50)
ALERE SAN DIEGO, INC.
DTH-114
In Commercial Distribution

  • 10815845020314 ()
  • 00815845020317 ()
4012390099

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 07 COC150/AMP/MAMP500/OPI300/MDMA/OXY/THC
REDWOOD TOXICOLOGY LABORATORY, INC.
011020177
In Commercial Distribution

  • 10858904006355 ()
  • 00858904006358 ()
DOA-174-721

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
PANEL 07 COC150/BZO/MAMP500/OPI300/MDMA/OXY/THC
REDWOOD TOXICOLOGY LABORATORY, INC.
011020176
In Commercial Distribution

  • 10858904006348 ()
  • 00858904006341 ()
DOA-174-711

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Syva® RapidTest d.a.u.® 3 THC / COC / OPI
Siemens Healthcare Diagnostics Inc.
10445358
In Commercial Distribution

  • 00842768001291 ()
  • 00630414013916 ()
6A179UL

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP1000/BAR300/BZO300/COC300/MET1000/THC/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCUPA06111 ()
  • B115ABCUPA06110 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
BZO300/COC150/MET500/OPI2000/OXY/THC/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCUPA06091 ()
  • B115ABCUPA06090 ()
ABCupA-06-09

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/COC150/MDMA/OPI2000/PCP/THC/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCUPA06081 ()
  • B115ABCUPA06080 ()
ABCupA-06-08

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

  • B115ABCUPA06041 ()
  • B115ABCUPA06040 ()
ABCupA-06-04

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

  • B115ABCUPA06011 ()
  • B115ABCUPA06010 ()
ABCupA-06-01

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

  • B115ABCUP09031 ()
  • B115ABCUP09030 ()
ABCup-09-03

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP1000/BAR300/BZO300/COC300/MET1000/THC/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARDA06111 ()
  • B115ABCARDA06110 ()
ABCardA-06-11

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
BZO300/COC150/MET500/OPI2000/OXY/THC/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARDA06091 ()
  • B115ABCARDA06090 ()
ABCardA-06-09

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/COC150/MDMA/OPI2000/PCP/THC/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARDA06081 ()
  • B115ABCARDA06080 ()
ABCardA-06-08

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

  • B115ABCARDA06041 ()
  • B115ABCARDA06040 ()
ABCardA-06-04

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

  • B115ABCARDA06011 ()
  • B115ABCARDA06010 ()
ABCardA-06-01

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

  • B115ABCARD09031 ()
  • B115ABCARD09030 ()
ABCard-09-03

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
OralTox 6 Panel - COC/MET/OPI/OXY/PCP/THC
PREMIER BIOTECH, INC
OT80622
Not in Commercial Distribution

  • B313OT806221 ()
  • B313OT806220 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6 Panel OralTox - AMP/COC/MET/OPI/OXY/THC
PREMIER BIOTECH, INC
OT80605
Not in Commercial Distribution

  • B313OT806051 ()
  • B313OT806050 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6 Panel OralTox - AMP/COC/MET/OPI/PCP/THC
PREMIER BIOTECH, INC
OT80602
Not in Commercial Distribution

  • B313OT806021 ()
  • B313OT806020 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel OralTox Device - COC/MET/OPI/OXY/THC
PREMIER BIOTECH, INC
OT80509
Not in Commercial Distribution

  • B313OT805091 ()
  • B313OT805090 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATSWAB saliva device, 25Pcs/Box COC/mAMP/OPI/THC
MICRO DISTRIBUTING, L.C
SSB-148
In Commercial Distribution

  • 00816036029003 ()
  • 00816036028501 ()
SSB-148

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
2-Panel STATDIP CLIA WAIVED Dipcard, COC/THC, 25Pcs/Box
MICRO DISTRIBUTING, L.C
SDP-124-0
In Commercial Distribution

  • 00816036025654 ()
  • 00816036026132 ()
SDP-124-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
accutest MultiDrug Screen-5 COC/M-AMP/MOP(300)/BZO/THC
JANT PHARMACAL CORPORATION
DS134AC425
In Commercial Distribution

  • 10763924134424 ()
  • 00763924134427 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
accutest MultiDrug Screen 5-panel (AMP/COC/PCP/OPI/THC)
JANT PHARMACAL CORPORATION
DS61AC425
In Commercial Distribution

  • 10763924061423 ()
  • 00763924061426 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Multi Drug Screen Test -THC,COT(15tests one kit)
EASY HEALTHCARE CORPORATION
EDOAP-124
In Commercial Distribution

  • 10810038634118 ()
  • 00810038634111 ()
  • 30810038634112 ()
EDOAP-124-15

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
No Description
Co-Innovation Biotech Co., Ltd
THC Strip/3.0mm
In Commercial Distribution

  • 06970429840614 ()
  • 06970429840607 ()
  • 06970429840508 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
No Description
MASIMO CORPORATION
1775
In Commercial Distribution

  • 10843997000489 ()
  • 00843997000482 ()


  • Pulse oximeter probe, single-use
No Description
MASIMO CORPORATION
1777
In Commercial Distribution

  • 10843997000472 ()
  • 00843997000475 ()


  • Pulse oximeter probe, single-use
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