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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5-Panel STATDIP CLIA WAIVED Dipcard, AMP/COC/MAMP/OPI/THC, 25Pcs/Box
MICRO DISTRIBUTING, L.C
SDP-254-0
In Commercial Distribution

  • 00816036025692 ()
  • 00816036026170 ()
SDP-254-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel STATDIP CLIA WAIVED Dipcard, COC/MAMP/MDMA/OPI/THC, 25Pcs/Box
MICRO DISTRIBUTING, L.C
SDP-1554-0
In Commercial Distribution

  • 00816036025685 ()
  • 00816036026163 ()
SDP-1554-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC (Cannabinoid) 50 ng/mL CX/LX/DXC 1 x 250 tests
CAROLINA LIQUID CHEMISTRIES CORPORATION
CC410A
Not in Commercial Distribution

  • 00817302021769 ()

  • Kit contains 1 reagent cartridge and 1 package insert
  • Total Volume: 65 Milliliter
  • Total Volume: 18 Milliliter
CC410A

  • Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
THC, COC, OPI, AMP, MET with Adulteration Screen for OX/SG/PH
AMEDITECH INC.
C-C0503A-3A
Not in Commercial Distribution

  • 00816565020526 ()
C-C0503A-3A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC, COC, OPI, MET, PCP with Adulteration Screen for OX/SG/PH
AMEDITECH INC.
C-C0502A-3A
Not in Commercial Distribution

  • 00816565020519 ()
C-C0502A-3A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC, COC, OPI, AMP, PCP with Adulteration Screen for OX/SG/PH
AMEDITECH INC.
C-C0501A-3A
Not in Commercial Distribution

  • 00816565020502 ()
C-C0501A-3A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
8 panel test cup, (COC/THC)+AMP+BZO+BUP+MET1000+MTD+OPI300
AMEDITECH INC.
IMC-8BB
Not in Commercial Distribution

  • 00816565020175 ()
IMC-8BB

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

  • B115ABCUPA09031 ()
  • B115ABCUPA09030 ()
ABCupA-09-03

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

  • B115ABCUP12061 ()
  • B115ABCUP12060 ()
ABCup-12-06

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

  • B115ABCUP12021 ()
  • B115ABCUP12020 ()
ABCup-12-02

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

  • B115ABCUP12011 ()
  • B115ABCUP12010 ()
ABCup-12-01

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

  • B115ABCARDA09031 ()
  • B115ABCARDA09030 ()
ABCardA-09-03

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

  • B115ABCARD12061 ()
  • B115ABCARD12060 ()
ABCard-12-06

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

  • B115ABCARD12021 ()
  • B115ABCARD12020 ()
ABCard-12-02

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

  • B115ABCARD12011 ()
  • B115ABCARD12010 ()
ABCard-12-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel Card; AMP,BAR,BUP,BZO,COC,mAMP,MTD,OPI,OXY,THC
WONDFO USA CO., LTD.
WDOA-9104
In Commercial Distribution

  • 00816862025767 ()
WDOA-9104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel Card; BAR,BUP,BZO,COC,mAMP,MTD,OPI,OXY,TCA,THC
WONDFO USA CO., LTD.
WDOA-7104
In Commercial Distribution

  • 00816862025729 ()
WDOA-7104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel Card; AMP,BAR,BZO,COC,mAMP,MOP,MTD,OXY,PCP,THC
WONDFO USA CO., LTD.
WDOA-4105
In Commercial Distribution

  • 00816862025644 ()
WDOA-4105

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel Card; AMP,BAR,BZO,COC,mAMP,MTD,OPI,OXY,PCP,THC
WONDFO USA CO., LTD.
WDOA-4104
In Commercial Distribution

  • 00816862025637 ()
WDOA-4104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel Card; AMP,BAR,BZO,COC,mAMP,MDMA,MTD,OPI,PCP,THC
WONDFO USA CO., LTD.
WDOA-3104
In Commercial Distribution

  • 00816862025606 ()
WDOA-3104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel Card; AMP,BAR,BZO,COC,mAMP,MTD,OPI,PCP,TCA,THC
WONDFO USA CO., LTD.
WDOA-1104
In Commercial Distribution

  • 00816862025491 ()
WDOA-1104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel T-Cup; AMP,BUP,BZO,COC,mAMP,MDMA,MTD,OPI,OXY,THC
WONDFO USA CO., LTD.
TDOA-8104
In Commercial Distribution

  • 00816862025330 ()
TDOA-8104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel T-Cup; BAR,BUP,BZO,COC,mAMP,MTD,OPI,OXY,TCA,THC
WONDFO USA CO., LTD.
TDOA-7104
In Commercial Distribution

  • 00816862025293 ()
TDOA-7104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel T-Cup; AMP,BAR,BZO,COC,mAMP,MTD,OPI,OXY,PCP,THC
WONDFO USA CO., LTD.
TDOA-4104
In Commercial Distribution

  • 00816862025200 ()
TDOA-4104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel T-Cup; AMP,BAR,BZO,COC,mAMP,MDMA,MTD,OPI,PCP,THC
WONDFO USA CO., LTD.
TDOA-3104
In Commercial Distribution

  • 00816862025170 ()
TDOA-3104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6-Panel T-Square no THC with Indicator; AMP,COC,MET,OPI,OXY,PCP
WONDFO USA CO., LTD.
QODOA-366NTEUO-I
In Commercial Distribution

  • 10816862023432 ()
  • 00816862023435 ()
  • 00816862023442 ()
QODOA-366NTEUO-I

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel Card; AMP,BAR,BUP,BZO,COC,mAMP,MTD,OPI,OXY,THC
WONDFO USA CO., LTD.
WDOA-9104
In Commercial Distribution

  • 10816862020769 ()
  • 00816862020762 ()
  • 00816862029765 ()
WDOA-9104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel Card; BAR,BUP,BZO,COC,mAMP,MTD,OPI,OXY,TCA,THC
WONDFO USA CO., LTD.
WDOA-7104
In Commercial Distribution

  • 10816862020721 ()
  • 00816862020724 ()
  • 00816862029727 ()
WDOA-7104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel T-Cup; AMP,BAR,BZO,COC,MDMA,MTD,OPI,OXY,PCP,THC
WONDFO USA CO., LTD.
TDOA-13104
In Commercial Distribution

  • 10816862024125 ()
  • 00816862024135 ()
  • 00816862024128 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel T-Cube; AMP,BAR,COC,MDMA,MET,MTD,OPI,OXY,PCP,THC
WONDFO USA CO., LTD.
ODOA-10106EUO
In Commercial Distribution

  • 10816862022046 ()
  • 00816862022049 ()
  • 00816862022056 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel Card; AMP,BAR,BZO,COC,mAMP,MOP,MTD,OXY,PCP,THC
WONDFO USA CO., LTD.
WDOA-4105
In Commercial Distribution

  • 10816862020646 ()
  • 00816862020649 ()
  • 00816862029642 ()
WDOA-4105

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel Card; AMP,BAR,BZO,COC,mAMP,MTD,OPI,OXY,PCP,THC
WONDFO USA CO., LTD.
WDOA-4104
In Commercial Distribution

  • 10816862020639 ()
  • 00816862020632 ()
  • 00816862029635 ()
WDOA-4104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel Card; AMP,BAR,BZO,COC,mAMP,MDMA,MTD,OPI,PCP,THC
WONDFO USA CO., LTD.
WDOA-3104
In Commercial Distribution

  • 10816862020608 ()
  • 00816862020601 ()
  • 00816862029604 ()
WDOA-3104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel Card; AMP,BAR,BZO,COC,mAMP,MTD,OPI,PCP,TCA,THC
WONDFO USA CO., LTD.
WDOA-1104
In Commercial Distribution

  • 10816862020493 ()
  • 00816862020496 ()
  • 00816862029499 ()
WDOA-1104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel T-Cup; AMP,BUP,BZO,COC,mAMP,MDMA,MTD,OPI,OXY,THC
WONDFO USA CO., LTD.
TDOA-8104
In Commercial Distribution

  • 10816862020332 ()
  • 00816862020335 ()
  • 00816862029338 ()
TDOA-8104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel T-Cup; BAR,BUP,BZO,COC,mAMP,MTD,OPI,OXY,TCA,THC
WONDFO USA CO., LTD.
TDOA-7104
In Commercial Distribution

  • 10816862020295 ()
  • 00816862020298 ()
  • 00816862029291 ()
TDOA-7104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel T-Cup; AMP,BAR,BZO,COC,mAMP,MTD,OPI,OXY,PCP,THC
WONDFO USA CO., LTD.
TDOA-4104
In Commercial Distribution

  • 10816862020202 ()
  • 00816862020205 ()
  • 00816862029208 ()
TDOA-4104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel T-Cup; AMP,BAR,BZO,COC,mAMP,MDMA,MTD,OPI,PCP,THC
WONDFO USA CO., LTD.
TDOA-3104
In Commercial Distribution

  • 10816862020172 ()
  • 00816862020175 ()
  • 00816862029178 ()
TDOA-3104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC, COC, OPI, AMP, PCP with Adulteration Screen for OX/SG/PH
BRANAN MEDICAL CORPORATION
C-C0501A-3A
Not in Commercial Distribution

  • 00816555020314 ()
C-C0501A-3A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC, COC, OPI, MET, PCP with Adulteration Screen for OX/SG/PH
BRANAN MEDICAL CORPORATION
C-C0502A-3A
Not in Commercial Distribution

  • 00816555020307 ()
C-C05020A-3A

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