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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8-Panel STATDIP CLIA WAIVED Dipcard, BAR/BZO/COC/MAMP/MOR/MTD/OXY/THC, 25Pcs/Box
MICRO DISTRIBUTING, L.C
SDP-384-0
In Commercial Distribution

  • 00816036025814 ()
  • 00816036026293 ()
SDP-384-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
8-Panel STATDIP CLIA WAIVED Dipcard, AMP/BAR/BZO/COC/MAMP/OPI/PCP/THC, 25Pcs/Box
MICRO DISTRIBUTING, L.C
SDP-184-0
In Commercial Distribution

  • 00816036025807 ()
  • 00816036026286 ()
SDP-184-0

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT II DOA 5 in 1 Test Cup, 25Pcs/Box BZO/COC/mAMP/MOR/THC
MICRO DISTRIBUTING, L.C
STATII-6357
In Commercial Distribution

  • 00816036021632 ()
  • 00816036021649 ()
STATII-6357

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT DOA 5 in 1 CLIA WaivedTest Cup, 25Pcs/Box THC/COC/OPI/mAMP/PCP
MICRO DISTRIBUTING, L.C
SCP-3257
In Commercial Distribution

  • 00816036021618 ()
  • 00816036021625 ()
SCP-3257

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT DOA 4 in 1 CLIA Waived Test Cup, 25Pcs/Box COC/mAMP/OPI/THC
MICRO DISTRIBUTING, L.C
SCP-1247
In Commercial Distribution

  • 00816036021229 ()
  • 00816036021403 ()
SCP-1247

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT DOA 6 in 1 Test Dipcard, 25Pcs/Box AMP/COC/mAMP/MOR/PCP/THC
MICRO DISTRIBUTING, L.C
SDP-564
In Commercial Distribution

  • 00816036020307 ()
  • 00816036020680 ()
SDP-564

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

  • 00816036020246 ()
  • 00816036020628 ()
SDP-254

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel Drug Screening Test Cup AMP/BAR/BZO/COC/MET/MTD/MOP/PCP/OXY/THC
MEDICAL DISTRIBUTION GROUP INC
ID-CP10-AZ5
In Commercial Distribution

  • 20850721007352 ()
  • 10850721007355 ()
  • 00850721007358 ()
ID-CP10-AZ5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel Drug Screening Test Cup AMP/BAR/BZO/COC/MET/MTD/MOP/PCP/OXY/THC
MEDICAL DISTRIBUTION GROUP INC
ID-CP10
In Commercial Distribution

  • 20850721007307 ()
  • 10850721007300 ()
  • 00850721007303 ()
ID-CP10

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel Drug Screening Test Cup AMP/BAR/BZO/COC/MET/MTD/MOP/PCP/OXY/THC
MEDICAL DISTRIBUTION GROUP INC
ID-CP10
In Commercial Distribution

  • 20850721007260 ()
  • 10850721007263 ()
  • 00850721007266 ()
ID-CP10

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel Drug Screening Test Cup AMP/BAR/BZO/COC/MET/MTD/MOP/PCP/OXY/THC
MEDICAL DISTRIBUTION GROUP INC
ID-CP10-AZ5
In Commercial Distribution

  • 20850721007239 ()
  • 10850721007232 ()
  • 00850721007235 ()
ID-CP10-AZ5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel Drug Screening Test Cup AMP/BAR/BZO/COC/MET/MTD/MOP/PCP/OXY/THC
MEDICAL DISTRIBUTION GROUP INC
ID-CP10
In Commercial Distribution

  • 20850721007208 ()
  • 10850721007201 ()
  • 00850721007204 ()
ID-CP10

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel Drug Test Cup AMP/BAR/BZO/COC/MET/MTD/OPI/PCP/PPX/THC
UCP BIOSCIENCES, INC.
U-CUP-13104
In Commercial Distribution

  • 00817038022252 ()
  • 10817038022259 ()
  • 20817038022256 ()
U-CUP-13104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
UCP Drug Test Mini Cups 5-Panel Drug Test Mini Cup AMP/COC/OPI/THC/PCP
UCP BIOSCIENCES, INC.
U-MCUP-154
In Commercial Distribution

  • 20817038022102 ()
  • 10817038022105 ()
  • 00817038022108 ()
U-MCUP-154

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
UCP Compact Drug Test Cards 6-Panel Drug Test Card COC/OPI/MTD/BZO/OXY/THC
UCP BIOSCIENCES, INC.
U-DOA-764L
In Commercial Distribution

  • 20817038021761 ()
  • 10817038021764 ()
  • 00817038021767 ()
U-DOA-764L

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel Drug Test Cup AMP/BUP/BZO/COC/MET/MDMA/MTD/MOP/OXY/THC
UCP BIOSCIENCES, INC.
U-CUP-9104
In Commercial Distribution

  • 20817038021341 ()
  • 10817038021344 ()
  • 00817038021347 ()
U-CUP-9104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel Drug Test Cup AMP/BUP/BZO/COC/MET/MDMA/MTD/OPI/OXY/THC
UCP BIOSCIENCES, INC.
U-CUP-8104
In Commercial Distribution

  • 20817038021129 ()
  • 10817038021122 ()
  • 00817038021125 ()
U-CUP-8104

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

  • 10816862026471 ()
  • 00816862026474 ()
  • 00816862026467 ()


  • 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
WONDFO USA CO., LTD.
TDOA-3135
In Commercial Distribution

  • 00816862025927 ()
TDOA-3135

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel T-Cup; BAR,BUP,BZO,COC,mAMP,MTD,OPI,OXY,TCA,THC with 3 AD*
WONDFO USA CO., LTD.
TDOA-7104A3
In Commercial Distribution

  • 00816862025309 ()
TDOA-7104A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
13-Panel T-Cup;AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MOP,MTD,OXY,PCP,TCA,THC
WONDFO USA CO., LTD.
TDOA-2135
In Commercial Distribution

  • 00816862025101 ()
TDOA-2135

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Prime Screen® 7-Panel T-Cup; 25 per box; AMP,BZO,COC,MET,OPI,OXY,THC
WONDFO USA CO., LTD.
DTDOA-274-25BX-A
In Commercial Distribution

  • 10816862024910 ()
  • 00816862024913 ()
  • 00816862024906 ()


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

  • 10816862023906 ()
  • 00816862023909 ()
  • 00816862023916 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9-Panel T-Square no THC with Indicator; AMP,BAR,COC,MDMA,MET,MTD,OPI,OXY,PCP
WONDFO USA CO., LTD.
QODOA-496NTEUO-I
In Commercial Distribution

  • 10816862023456 ()
  • 00816862023459 ()
  • 00816862023466 ()
QODOA-496NTEUO-I

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

  • 00816862022407 ()
  • 00816862022384 ()
  • 00816862022391 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel T-Cup Compact; AMP,BAR,BUP,BZO,COC,MDMA,MTD,OPI,OXY,PCP,TCA,THC
WONDFO USA CO., LTD.
CDOA-3124
In Commercial Distribution

  • 10816862021537 ()
  • 00816862021530 ()
  • 00816862028539 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel Card for Cup; AMP,COC,mAMP,OPI,THC with 3 AD (OX,SG,pH)
WONDFO USA CO., LTD.
WDOA-254A-A3
In Commercial Distribution

  • 10816862021315 ()
  • 00816862021318 ()
  • 00816862028317 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel Preview Cup; AMP,BAR,BZO,COC,MDMA,MET,MOP,MTD,OXY,PCP,TCA,THC
WONDFO USA CO., LTD.
PRE-PDOA-7125
In Commercial Distribution

  • 10816862021186 ()
  • 00816862021189 ()
  • 00816862028188 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel Preview Cup; AMP,BAR,BUP,BZO,COC,MDMA,MET,MOP,MTD,OXY,PCP,THC
WONDFO USA CO., LTD.
PRE-PDOA-6125
In Commercial Distribution

  • 10816862021179 ()
  • 00816862021172 ()
  • 00816862028171 ()


  • 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
WONDFO USA CO., LTD.
TDOA-3135
In Commercial Distribution

  • 10816862020929 ()
  • 00816862020922 ()
  • 00816862025927 ()
TDOA-3135

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
11-Panel Dip Drug Screen (THC/COC/MOP/AMP/MET/PCP/BAR/BZO/MDMA/MTD/OXY)
WONDFO USA CO., LTD.
WD-11MT
In Commercial Distribution

  • 10816862020370 ()
  • 00816862020373 ()
  • 00816862029376 ()
WD-11MT

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel T-Cup; AMP,BAR,BZO,COC,mAMP,MDMA,MTD,OPI,PCP,THC with 3 AD*
WONDFO USA CO., LTD.
TDOA-3104A3
In Commercial Distribution

  • 10816862020189 ()
  • 00816862020182 ()
  • 00816862029185 ()
TDOA-3104A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
13-Panel T-Cup;AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MOP,MTD,OXY,PCP,TCA,THC
WONDFO USA CO., LTD.
TDOA-2135
In Commercial Distribution

  • 10816862020103 ()
  • 00816862020106 ()
  • 00816862029109 ()
TDOA-2135

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: THC / COC
RAPID DIAGNOSTICS INC
07RD7108-01
In Commercial Distribution

  • 00817830022559 ()

  • Height: 74 Millimeter
07RD7108-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: COC / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7108-01
In Commercial Distribution

  • M90107RD7108010 ()

  • Length: 74 Millimeter
07RD7108-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: MAMP / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7061-03
In Commercial Distribution

  • M90107RD7061031 ()
  • M90107RD7061030 ()

  • Length: 75 Millimeter
07RD7061-03

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: COC / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7061-01
In Commercial Distribution

  • M90107RD7061011 ()
  • M90107RD7061010 ()

  • Length: 75 Millimeter
07RD7061-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel DOA Cup, AMP500/BUP/BZO/COC150/FYL5/MET500/MOR/MTD/OXY/THC, 25tests/kit
CHEMTRON BIOTECH INC
PCU-10FCW-25
In Commercial Distribution

  • 00812203030766 ()
PCU-10FCW-25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel DOA Dip, AMP/BZO/COC/MTD/MDMA/MET/MOR/OXY/BUP/TML/FYL5/THC
CHEMTRON BIOTECH INC
711L10-G
In Commercial Distribution

  • 00812203030711 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12-Panel DrugSmart Dip, AMP300/MOR/COC150/THC/MET500/PCP/BAR/BZO/MTD/MDMA/OXY/BUP
CHEMTRON BIOTECH INC
C-31223D
In Commercial Distribution

  • 00812203030179 ()


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