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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BlueRapids CLIA Waived Drug Cup; 5-Panal AMP/COC/PCP/OPI2000/THC
MERCEDES MEDICAL, LLC
TNR MM5CPCP
In Commercial Distribution

  • 10850011007027 ()
  • 00850011007020 ()
  • 20850011007024 ()
TNR MM5CPCP

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Morphine/morphine metabolite IVD, kit, rapid ICT, clinical
  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Amphetamine-specific IVD, kit, rapid ICT, clinical
BluRapids CLIA Waived Drug Cup; 5-Panel AMP/COC/MET/OPI/THC
MERCEDES MEDICAL, LLC
TNR MM5CMET
In Commercial Distribution

  • 20850011007017 ()
  • 10850011007010 ()
  • 00850011007013 ()
TNR MM5CMET

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Opiate/opiate metabolite IVD, kit, liquid chromatography
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Amphetamine-specific IVD, kit, rapid ICT, clinical
Amazewell™ D-Pen™ Mini THC Oral Fluid Test, 10T/Box
Guangzhou Decheng Biotechnology Co., LTD
DPM-THC-10B
In Commercial Distribution

  • 30850054867033 ()
  • 00850054867032 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
10 tests kit; 5-Panel Dip Card; THC/COC/OPI/BZO/MET
EASY HEALTHCARE CORPORATION
EDOAP-654
In Commercial Distribution

  • 01085025300792 ()
  • 00850253007925 ()
  • 30850253007926 ()
EDOAP-654-10

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
25 tests kit;5-Panel Dip Card;AMP/BZO/COC/OPI/THC
EASY HEALTHCARE CORPORATION
EDOAP-754
In Commercial Distribution

  • 10850253007380 ()
  • 00850253007383 ()
  • 30850253007384 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
15 tests kit;5-Panel Dip Card;AMP/BZO/COC/OPI/THC
EASY HEALTHCARE CORPORATION
EDOAP-754
In Commercial Distribution

  • 10850253007373 ()
  • 00850253007376 ()
  • 30850253007377 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 tests kit;5-Panel Dip Card;AMP/BZO/COC/OPI/THC
EASY HEALTHCARE CORPORATION
EDOAP-754
In Commercial Distribution

  • 10850253007366 ()
  • 00850253007369 ()
  • 30850253007360 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
2 tests kit;5-Panel Dip Card;AMP/BZO/COC/OPI/THC
EASY HEALTHCARE CORPORATION
EDOAP-754
In Commercial Distribution

  • 10850253007359 ()
  • 00850253007352 ()
  • 30850253007353 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 tests kit;5-Panel Dip Card;THC/COC/OPI/AMP/MET
EASY HEALTHCARE CORPORATION
EDOAP-254
In Commercial Distribution

  • 10850253007342 ()
  • 00850253007345 ()
  • 30850253007346 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 tests kit;5-Panel Dip Card;THC/COC/OPI/AMP/MET
EASY HEALTHCARE CORPORATION
EDOAP-254
In Commercial Distribution

  • 10850253007335 ()
  • 00850253007338 ()
  • 30850253007339 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
15 tests kit ;5-Panel Dip Card;THC/COC/OPI/AMP/MET
EASY HEALTHCARE CORPORATION
EDOAP-254
In Commercial Distribution

  • 10850253007328 ()
  • 00850253007321 ()
  • 30850253007322 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
25 tests kit;5-Panel Dip Card;THC/COC/OPI/AMP/MET
EASY HEALTHCARE CORPORATION
EDOAP-254
In Commercial Distribution

  • 10850253007311 ()
  • 00850253007314 ()
  • 30850253007315 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC/COC/AMP/BZO/OPI/MET drugs of abuse test cup
Twin Spirit Inc.
60600D
Not in Commercial Distribution

  • 00859144006177 ()
60600D

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC/COC/AMP/MET/OPI/OXY drugs of abuse test cup
Twin Spirit Inc.
60620D
Not in Commercial Distribution

  • 00859144006160 ()
60620D

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 tests kit; 5-Panel Dip Cards; AMP/BZO/COC/OPI/THC
IDUN SOLUTIONS LLC
IDOA-755-5P
Not in Commercial Distribution

  • 00857275007131 ()
  • 00857275007032 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, kit, rapid ICT, clinical
  • Amphetamine-specific IVD, kit, rapid ICT, clinical
  • Morphine/morphine metabolite IVD, kit, rapid ICT, clinical
10 tests kit;5-Panel Dip Card; AMP/BZO/COC/OPI/THC
EASY HEALTHCARE CORPORATION
EDOAP-754
In Commercial Distribution

  • 10855944007458 ()
  • 00855944007451 ()
  • 30855944007452 ()
EDOAP-754-10

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
25 tests kit;5-Panel Dip Card;THC/COC/OPI/BZO/MET
EASY HEALTHCARE CORPORATION
EDOAP-654
In Commercial Distribution

  • 10855944007038 ()
  • 00855944007031 ()
  • 30855944007032 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Card, (MET1000/OPI2000)+AMP+COC+PCP+THC
Instant Tech Subsidiary Acquisition
PSD-6MP
Not in Commercial Distribution

  • 00858998006845 ()
PSD-6MP

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Card, (MET1000/OPI2000)+BZO+COC+OXY+THC
Instant Tech Subsidiary Acquisition
PSD-6MBO
Not in Commercial Distribution

  • 00858998006838 ()
PSD-6MBO

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Card, (MET1000/OPI2000)+AMP+BZO+COC+THC
Instant Tech Subsidiary Acquisition
PSD-6MB
Not in Commercial Distribution

  • 00858998006821 ()
PSD-6MB

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Cup, CLIA-Waived, AMP/BZO/COC/OPI2000/OXY/THC
Instant Tech Subsidiary Acquisition
PSCup-6BO-W
Not in Commercial Distribution

  • 00858998006517 ()
PSCup-6BO-W

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6-Panel UScreen Dip Drug Screen (THC/COC/OPI2000/AMP/MET/BZO)
Instant Tech Subsidiary Acquisition
USSDip-6MB
Not in Commercial Distribution

  • 00858998006197 ()
USSDip-6MB

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6-Panel UScreen Dip Drug Screen (THC/COC/OPI2000/MAMP/BZO/OXY)
Instant Tech Subsidiary Acquisition
USSDip-6BO
Not in Commercial Distribution

  • 00858998006005 ()
USSDip-6BO

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP, BZO, COC, MET, OPI, THC drugs of abuse test cup
NEXSCREEN, LLC
C-60613N
In Commercial Distribution

  • 00858984006170 ()
C-60613N

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Syva® RapidTest d.a.u.® 5 mAMP / OPI / COC / THC / PCP
Siemens Healthcare Diagnostics Inc.
10445360
In Commercial Distribution

  • 00842768001314 ()
  • 00630414013947 ()
6A259UL

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC Single Test Strip Sealed Pouch (4mm); 100pcs/bag Clia Waived
W.H.P.M. INC.
D4-D04-100
In Commercial Distribution

  • 00841824100701 ()
  • 00841824101692 ()
D4-D04-100

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
DrugSmart Cup 5, AMP/COC/OPI/OXY/THC, 25 tests/kit
CHEMTRON BIOTECH INC
60565D
In Commercial Distribution

  • 00812203030124 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/BZO300/COC150/ETG/K2/MDMA/MET500/MOR300/OXY/PCP/THC
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCUP12101 ()
  • B115ABCUP12100 ()
ABCup-12-10

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

  • B115ABCUP11071 ()
  • B115ABCUP11070 ()
ABCup-11-07

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

  • B115ABCUP11041 ()
  • B115ABCUP11040 ()
ABCup-11-04

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

  • B115ABCUP11011 ()
  • B115ABCUP11010 ()
ABCup-11-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP1000/BUP5/BZO300/COC150/MET1000/OPI300/OXY/THC/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARDA08051 ()
  • B115ABCARDA08050 ()
ABCardA-08-05

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/BZO300/COC150/ETG/K2/MDMA/MET500/MOR300/OXY/PCP/THC
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCARD12101 ()
  • B115ABCARD12100 ()
ABCard-12-10

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

  • B115ABCARD11071 ()
  • B115ABCARD11070 ()
ABCard-11-07

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

  • B115ABCARD11041 ()
  • B115ABCARD11040 ()
ABCard-11-04

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

  • B115ABCARD11011 ()
  • B115ABCARD11010 ()
ABCard-11-01

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

  • B115ABCARDA08011 ()
  • B115ABCARDA08010 ()
ABCardA-08-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP1000/BUP5/BZO300/COC150/MET1000/OPI300/OXY/THC/(OX/pH/SG)
ADVIN BIOTECH, INC.
1
In Commercial Distribution

  • B115ABCUPA08051 ()
  • B115ABCUPA08050 ()
ABCupA-08-05

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

  • B115ABCUPA08011 ()
  • B115ABCUPA08010 ()
ABCupA-08-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Card, (MET1000/OPI2000)+BZO+COC+OXY+THC
Instant Technologies, Inc.
PSD-6MBO
Not in Commercial Distribution

  • 00817405020720 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Card, (MET1000/OPI2000)+AMP+BZO+COC+THC
Instant Technologies, Inc.
PSD-6MB
Not in Commercial Distribution

  • 00817405020713 ()


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

  • 10816862021469 ()
  • 00816862021462 ()
  • 00816862028461 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9-Panel Card; AMP,BUP,BZO,COC,MOP,MTD,OXY,PPX,THC
WONDFO USA CO., LTD.
WDOA-295
In Commercial Distribution

  • 00816862025590 ()
WDOA-295

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6-Panel T-Cup; AMP,BZO,COC,mAMP,OPI,THC with 3 AD*
WONDFO USA CO., LTD.
TDOA-264A3
In Commercial Distribution

  • 00816862025156 ()
TDOA-264A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5-Panel T-Square no THC with Indicator; AMP,COC,MET,OPI,PCP
WONDFO USA CO., LTD.
QODOA-156NTEUO-I
In Commercial Distribution

  • 10816862023418 ()
  • 00816862023411 ()
  • 00816862023428 ()
QODOA-156NTEUO-I

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

  • 10816862023081 ()
  • 00816862023084 ()
  • 00816862023091 ()
QODOA-376EUO-I

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7 panel test cup, AMP/BAR/BZO/COC/OPI2000/PCP/THC
AMEDITECH INC.
IMC-7P
Not in Commercial Distribution

  • 00816565020168 ()
IMC-7P

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
(BZO/BAR)+(COC/THC)+(PCP/AMP)+MET1000+TCA multiple drugs dipcard
AMEDITECH INC.
IMD-8MT
Not in Commercial Distribution

  • 00816565020083 ()
IMD-8MT

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
THC, COC, OPI, AMP, MET, PCP, BAR, BZO, MTD, TCA, OXY
BRANAN MEDICAL CORPORATION
C-60B02
Not in Commercial Distribution

  • 00816555021472 ()
C-60B02

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6-Panel T-Cup; AMP,BZO,COC,mAMP,OPI,THC with 3 AD*
WONDFO USA CO., LTD.
TDOA-264A3
In Commercial Distribution

  • 10816862020158 ()
  • 00816862020151 ()
  • 00816862029154 ()
TDOA-264A3

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