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 Urine Test MET500, MOR300, THC
ALFA SCIENTIFIC DESIGNS, INC.
03-3311
In Commercial Distribution

  • 10796918000696 ()
  • 00796918000699 ()


  • 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
Rapid Response Saliva Drug Test (COT/THC) - THC40, COT30
BTNX Inc
D2.12-2FC1
In Commercial Distribution

  • 00722066008362 ()
  • 10722066008369 ()


  • Cotinine IVD, kit, rapid ICT, clinical
7-Panel Card; AMP,BZO,COC,mAMP,OPI,OXY,THC
WONDFO USA CO., LTD.
WDOA-274
In Commercial Distribution

  • 00816862025583 ()
WDOA-274

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6-Panel Key Cup; AMP,BZO,COC,mAMP,OPI,THC
WONDFO USA CO., LTD.
KDOA-264
In Commercial Distribution

  • 00816862025019 ()
KDOA-264

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel T-Square with indicator; AMP, COC, MET, OPI, THC
WONDFO USA CO., LTD.
QODOA-256EUO-I
In Commercial Distribution

  • 10816862022855 ()
  • 00816862022858 ()
  • 00816862022865 ()
QODOA-256EUO-I

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel T-Square with indicator; AMP, COC, MET, OPI, THC
WONDFO USA CO., LTD.
DQODOA-256EUO-I-25BX-A
In Commercial Distribution

  • 10816862022657 ()
  • 00816862022650 ()
  • 00816862023602 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6-Panel T-Cup Compact; BZO,COC,mAMP,OPI,OXY,THC
WONDFO USA CO., LTD.
CDOA-564
In Commercial Distribution

  • 00816862022087 ()
  • 00816862022094 ()
  • 10816862022084 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Strips; THC Marijuana/Cannabinoids Test Retail Box 10 Pcs
WONDFO USA CO., LTD.
WDTH114-10BX
In Commercial Distribution

  • 10816862021964 ()
  • 00816862021967 ()
  • 00816862021974 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel Preview Dip Card; AMP, COC, mAMP, OPI, THC
WONDFO USA CO., LTD.
PRE-WDOA-254
In Commercial Distribution

  • 10816862021452 ()
  • 00816862021455 ()
  • 00816862028454 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7-Panel Card; AMP,BZO,COC,mAMP,OPI,OXY,THC
WONDFO USA CO., LTD.
WDOA-274
In Commercial Distribution

  • 10816862020585 ()
  • 00816862020588 ()
  • 00816862029581 ()
WDOA-274

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6-Panel Key Cup; AMP,BZO,COC,mAMP,OPI,THC
WONDFO USA CO., LTD.
KDOA-264
In Commercial Distribution

  • 10816862020011 ()
  • 00816862020014 ()
  • 00816862029017 ()
KDOA-264

  • 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
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
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
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
6-Panel T-Cup Compact; AMP,BZO,COC,mAMP,OPI,THC
WONDFO USA CO., LTD.
CDOA-264
In Commercial Distribution

  • 10816862026419 ()
  • 00816862026412 ()
  • 00816862026405 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7-Panel T-Cup; AMP,BZO,COC,mAMP,OPI,OXY,THC
WONDFO USA CO., LTD.
TDOA-274
In Commercial Distribution

  • 00816862025163 ()
TDOA-274

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7-Panel T-Cube; AMP,COC,MET,OPI,OXY,PCP,THC
WONDFO USA CO., LTD.
ODOA-376EUO
In Commercial Distribution

  • 10816862022022 ()
  • 00816862022025 ()
  • 00816862022032 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel Card for Cup; AMP,COC,mAMP,OPI,THC
WONDFO USA CO., LTD.
WDOA-254A
In Commercial Distribution

  • 10816862021254 ()
  • 00816862021257 ()
  • 00816862028256 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7-Panel T-Cup; AMP,BZO,COC,mAMP,OPI,OXY,THC
WONDFO USA CO., LTD.
TDOA-274
In Commercial Distribution

  • 10816862020165 ()
  • 00816862020168 ()
  • 00816862029161 ()
TDOA-274

  • 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
5 panel test cup, BZO/COC/MET1000/OPI300/THC
AMEDITECH INC.
IMC-5MB300
Not in Commercial Distribution

  • 00816565020151 ()
IMC-5MB300

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 panel test cup, AMP/COC/MET1000/OPI2000/THC
AMEDITECH INC.
IMC-5M
Not in Commercial Distribution

  • 00816565020144 ()
IMC-5M

  • 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)
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
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
2335
In Commercial Distribution

  • 00843997001434 ()


  • Electrical-only medical device connection cable, reusable
No Description
MASIMO CORPORATION
1949
In Commercial Distribution

  • 00843997001427 ()


  • Electrical-only medical device connection cable, reusable
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