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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Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BZD / COC / M-AMP / MTD / OPI-II/ THC
RAPID DIAGNOSTICS INC
07RD7071-01A
In Commercial Distribution

  • 00817830022092 ()

  • Length: 75 Millimeter
07RD7071-01A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / COC / M-AMP / OPI / OXY / PCP / THC
RAPID DIAGNOSTICS INC
07RD7114-05
In Commercial Distribution

  • 00817830020562 ()

  • Height: 74 Millimeter
07RD7114-05

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BUP / BZD / COC / M-AMP / MTD / OPI / THC
RAPID DIAGNOSTICS INC
07RD7114-04
In Commercial Distribution

  • 00817830020555 ()

  • Height: 74 Millimeter
07RD7114-04

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / COC / M-AMP / MTD / OPI / OXY / THC
RAPID DIAGNOSTICS INC
07RD7114-03
In Commercial Distribution

  • 00817830020548 ()

  • Height: 74 Millimeter
07RD7114-03

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BZD / COC / M-AMP / OPI / OXY / THC
RAPID DIAGNOSTICS INC
07RD7114-02
In Commercial Distribution

  • 00817830020531 ()

  • Height: 74 Millimeter
07RD7114-02

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BUP / BZD / COC / MTD / OPI / OPI-II / THC
RAPID DIAGNOSTICS INC
07RD7114-01
In Commercial Distribution

  • 00817830020524 ()

  • Height: 74 Millimeter
07RD7114-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BZD / COC / MTD / OPI / OXY / THC
RAPID DIAGNOSTICS INC
07RD7071-12
In Commercial Distribution

  • 00817830022177 ()

  • Length: 75 Millimeter
07RD7071-12

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BZD / COC / M-AMP / OPI / PCP / THC
RAPID DIAGNOSTICS INC
07RD7071-04
In Commercial Distribution

  • 00817830022146 ()

  • Length: 75 Millimeter
07RD7071-04

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / BUP / COC / M-AMP / MTD / OPI / THC
RAPID DIAGNOSTICS INC
07RD7071-03
In Commercial Distribution

  • 00817830022122 ()

  • Length: 75 Millimeter
07RD7071-03

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / COC / M-AMP / MTD / OPI / PCP / THC
RAPID DIAGNOSTICS INC
07RD7071-02
In Commercial Distribution

  • 00817830022108 ()

  • Length: 75 Millimeter
07RD7071-02

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BZD / COC / M-AMP / MTD / OPI / THC
RAPID DIAGNOSTICS INC
07RD7071-01
In Commercial Distribution

  • 00817830022085 ()

  • Length: 75 Millimeter
07RD7071-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BUP / BZD / COC / MTD / OPI /OXY / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7208-11
In Commercial Distribution

  • M90107RD7208110 ()

  • Length: 74 Millimeter
07RD7208-11

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BUP / BZD / COC / M-AMP / OPI / OXY / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7208-10
In Commercial Distribution

  • M90107RD7208100 ()

  • Length: 74 Millimeter
07RD7208-10

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BUP / BZD / COC / M-AMP / OPI / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7071-20
In Commercial Distribution

  • M90107RD7071201 ()
  • M90107RD7071200 ()

  • Length: 75 Millimeter
07RD7071-20

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BZD / COC / MTD / OPI / OXY / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7071-12
In Commercial Distribution

  • M90107RD7071121 ()
  • M90107RD7071120 ()

  • Length: 75 Millimeter
07RD7071-12

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Card, (COC/THC)+(MET1000/OPI2000)+(PCP/AMP)+BAR+BZO+MTD+PPX with Cr, Ni, pH, Bl, S.G.
Instant Technologies, Inc.
PSDA-10X
Not in Commercial Distribution



  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drugs of Abuse Test Card, (COC/THC)+(MET1000/OPI2000)+(OXY/MDMA)+(PCP/AMP)+BAR+BZO with Cr, Ni, pH, Bl, S.G.
Instant Technologies, Inc.
PSDA-10CT
Not in Commercial Distribution

  • 00817405020898 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
iScreen™ Urine Test Drug Screen Card 12 Panel (AMP/BAR/BUP/BZO/COC/MDMA/MET/MOP/MTD/OXY/TCA/THC)
Instant Technologies, Inc.
IS12BUP-DX2
In Commercial Distribution

  • 00817405021321 ()
  • 10817405021328 ()
IS12BUP-DX2

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
iScreen™ Urine Test Drug Screen Card 12 Panel (AMP/BAR/BZO/COC/MDMA/MET/MOP/MTD/OXY/PCP/TCA/THC)
Instant Technologies, Inc.
IS12-DX2
In Commercial Distribution

  • 00817405021314 ()
  • 10817405021311 ()
IS12-DX2

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
UCP Compact Drug Test Cups 12-Panel Drug Test Cup BZO/BAR/COC/THC/MET/MOP/MTD/TCA/OXY/MDMA/AMP/BUP
UCP BIOSCIENCES, INC.
U-CUP-9124-RCLN
In Commercial Distribution

  • 20817038021648 ()
  • 10817038021641 ()
  • 00817038021644 ()
U-CUP-9124-RCLN

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel Drug Test Cup BAR/BUP/BZO/COC/MET/MTD/OPI/OXY/TCA/THC with Adulteration strip(S.G.,CRE, pH)
UCP BIOSCIENCES, INC.
U-DUD-7104
In Commercial Distribution

  • 20817038021419 ()
  • 10817038021412 ()
  • 00817038021415 ()
U-DUD-7104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
"Identify® Diagnostics Drug Test Cups 10-Panel Drug Screening Test Cup AMP/BAR/BZO/COC/MET/MTD/MOP/PCP/OXY/THC"
MEDICAL DISTRIBUTION GROUP INC
ID-CP10-AZ10
In Commercial Distribution

  • 20850721007963 ()
  • 10850721007966 ()
  • 00850721007969 ()
ID-CP10-AZ10

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Identify®Diagnostics Drug Test Cups 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

  • 20850721007796 ()
  • 10850721007799 ()
  • 00850721007792 ()
  • 30850721007793 ()
ID-CP10-AZ5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Identify®Diagnostics Drug Test Cups 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

  • 20850721007758 ()
  • 10850721007751 ()
  • 00850721007754 ()
ID-CP10-AZ5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Identify® Diagnostics Drug Test Cards 10 Panel Drug Test Card THC/COC/MOP/OXY/MDMA/AMP/BAR/BZO/MET/MTD
MEDICAL DISTRIBUTION GROUP INC
ID-CP10-DIP-AZ10
In Commercial Distribution

  • 20850721007680 ()
  • 10850721007683 ()
  • 00850721007686 ()
ID-CP10-DIP-AZ10

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
UCP Home TM Drug Screening Test Cards 9 Panel Drug Test Card AMP/BUP/BZO/COC/mAMP/MOP/MTD/OXY/THC
MEDICAL DISTRIBUTION GROUP INC
UCP9-DIP-B-394
In Commercial Distribution

  • 20850721007529 ()
  • 10850721007522 ()
  • 00850721007525 ()
UCP9-DIP-B-394

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Identify® Diagnostics Drug Test Cards 10 panel Drug Test Card THC/COC/MOP/OXY/MDMA/AMP/BAR/BZO/MET/MTD
MEDICAL DISTRIBUTION GROUP INC
ID-CP10-DIP-AZ25
In Commercial Distribution

  • 20850721007499 ()
  • 10850721007492 ()
  • 00850721007495 ()
ID-CP10-DIP-AZ25

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Identify® Diagnostics Drug Test Cards 10 panel Drug Test Card THC/COC/MOP/OXY/MDMA/AMP/BAR/BZO/MET/MTD
MEDICAL DISTRIBUTION GROUP INC
ID-CP10-DIP-AZ5
In Commercial Distribution

  • 20850721007482 ()
  • 10850721007485 ()
  • 00850721007488 ()
ID-CP10-DIP-AZ5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Identify® Diagnostics Drug Test Cups 10-Panel Drug Screening Test Cup AMP/BAR/BZO/COC/MET/MTD/MOP/PCP/OXY/THC
MEDICAL DISTRIBUTION GROUP INC
ID-CP10-AZ10
In Commercial Distribution

  • 00850013035090 ()
  • 10850013035097 ()
  • 20850013035094 ()
ID-CP10-AZ10

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Identify® Diagnostics Drug Test Cups 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

  • 20850013035070 ()
  • 10850013035073 ()
  • 00850013035076 ()
ID-CP10-AZ5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Chemtrue 12-Panel DOA Cup Test, AMP/BAR/BUP/BZO/COC150/MDMA/MET/MTD/OPI/OXY/PCP/THC + A-strip (Cr/Ox/pH)
CHEMTRON BIOTECH INC
712L17A-CT
In Commercial Distribution

  • 00812203030520 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP 9 Panel Test Cup w/Adulterants, AMP/BAR/BZO/COC/mAMP/MOR/MTD/PCP/THC + CR,OX,pH , 25Pcs/Box
MICRO DISTRIBUTING, L.C
SCP-2397-0-A
In Commercial Distribution

  • 00816036025494 ()
  • 00816036025487 ()
SCP-2397-0-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP II 6 Panel CLIA Waived Test Cup, with Adulterants 25Pcs/Box AMP/COC/mAMP/OPI/PCP/THC +pH, OX, CR.
MICRO DISTRIBUTING, L.C
STATII-4267-0-A
In Commercial Distribution

  • 00816036025401 ()
  • 00816036025418 ()
STATII-4267-0-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP II 10 Panel Test Cup W/AD, AMP/BAR/BZO/COC/mAMP/MOR/MTD/OXY/PCP/THC + PH-CR-OX, 25Pcs/Box
MICRO DISTRIBUTING, L.C
STATⅡ-41107-0-A
In Commercial Distribution

  • 00816036025111 ()
  • 00816036025272 ()
STATⅡ-41107-0-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STATCUP II 10 Panel Test Cup W/AD, AMP/BUP/BZO/COC/mAMP/MDMA/MOR/MTD/OXY/THC + PH-CR-OX, 25Pcs/Box
MICRO DISTRIBUTING, L.C
STATⅡ-12107-0-A
In Commercial Distribution

  • 00816036025081 ()
  • 00816036025241 ()
STATⅡ-12107-0-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT DOA 10 in 1 CLIA Waived Test Dipcard, 25Pcs/Box AMP/BAR/BZO/COC/mAMP/MTD/OPI/PCP/PPX/THC
MICRO DISTRIBUTING, L.C
SDP-5104
In Commercial Distribution

  • 00816036021960 ()
  • 00816036021953 ()
SDP-5104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
FASTEST 12 Panel CLIA WAIVED Test Cup, AMP/BARB/BUP/BZO/COC/mAMP/MDMA/MOR/MTD/OXY/PCP/THC, 25Pcs/Box
MICRO DISTRIBUTING, L.C
FST-71127
In Commercial Distribution

  • 00816036021687 ()
  • 00816036021694 ()
FST-71127

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT DOA 11 in 1 CLIA Waived Dipcard, 25Pcs/Box AMP/BARB/BUP/BZO/COC/mAMP/MOR/MTD/OXY/PCP/THC
MICRO DISTRIBUTING, L.C
SDP-2114
In Commercial Distribution

  • 00816036021571 ()
  • 00816036021588 ()
SDP-2114

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT DOA 10 in 1 Test Cup W/AD, 25Pcs/Box AMP/BAR/BZO/COC/mAMP/MTD/OPI/PCP//PPX/THC/
MICRO DISTRIBUTING, L.C
SCP-31107
In Commercial Distribution

  • 00816036021625 ()
  • 00816036021403 ()
SCP-31107

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT DOA 10 in 1 CLIA Waived Test Cup, 25Pcs/Box AMP/BAR/BZO/COC/mAMP/MDMA/MTD/OPI/PCP/THC
MICRO DISTRIBUTING, L.C
SCP-21107
In Commercial Distribution

  • 00816036021380 ()
  • 00816036021564 ()
SCP-21107

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT 6 in 1 CLIA Waived Test Cup W/AD, 25Pcs/Box COC/BZO/mAMP/MOR/OXY/THC+pH,SG,OX
MICRO DISTRIBUTING, L.C
SCP-6167-A
In Commercial Distribution

  • 00816036021304 ()
  • 00816036021489 ()
SCP-6167-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT II DOA 6 in 1 Test Cup W/AD, 25Pcs/Box BZO/COC/mAMP/MOR/OXY/THC + pH - CR- OX
MICRO DISTRIBUTING, L.C
STATⅡ-6167-A-CR
In Commercial Distribution

  • 00816036020840 ()
  • 00816036021052 ()
STATⅡ-6167-A-CR

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT II DOA 6 in 1 CLIA Waived Test Cup W/AD, 25Pcs/Box AMP/BZO/COC/mAMP/MOR/THC/PH-CR-OX
MICRO DISTRIBUTING, L.C
STATⅡ-2167-3-A
In Commercial Distribution

  • 00816036020833 ()
  • 00816036021045 ()
STATⅡ-2167-3-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT DOA 10 in 1 CLIA Waived Test Dipcard, 25Pcs/Box AMP/BUP/BZO/COC/mAMP/MDMA/MOR/OXY/PCP/THC
MICRO DISTRIBUTING, L.C
SDP-8104
In Commercial Distribution

  • 00816036020406 ()
  • 00816036020413 ()
SDP-8104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT DOA 10 in 1 Test Cassette with Pipette, 20Pcs/Box AMP/BAR/BZO/COC/mAMP/MDMA/MTD/OPI/PCP/THC
MICRO DISTRIBUTING, L.C
SCS-22105
In Commercial Distribution

  • 00816036020390 ()
  • 00816036020789 ()
SCS-22105

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT DOA 10 in 1 CLIA Waived Test Dipcard, 25Pcs/Box AMP/BAR/BZO/COC/mAMP/MTD/OPI/PCP/TCA/THC
MICRO DISTRIBUTING, L.C
SDP-1104
In Commercial Distribution

  • 00816036020369 ()
  • 00816036020758 ()
SDP-1104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT DOA 10 in 1 CLIA Waived Test Dipcard, 25Pcs/Box AMP/BAR/BZO/COC/mAMP/MOR/MTD/OXY/PCP/THC
MICRO DISTRIBUTING, L.C
SDP-6104
In Commercial Distribution

  • 00816036020352 ()
  • 00816036020741 ()
SDP-6104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT DOA 10 in 1 CLIA Waived Test Dipcard, 25Pcs/Box AMP/BAR/BZO/COC/mAMP/MDMA/MTD/OPI/PCP/THC
MICRO DISTRIBUTING, L.C
SDP-4104
In Commercial Distribution

  • 00816036020345 ()
  • 00816036020734 ()
SDP-4104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT DOA 5 in 1 CLIA Waived Test Dipcard W/AD, 25Pcs/Box COC/mAMP/OPI/PCP/THC+pH,SG,OX
MICRO DISTRIBUTING, L.C
SDP-354-A
In Commercial Distribution

  • 00816036020215 ()
  • 00816036020598 ()
SDP-354-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Drug Test Cup 5+3 for visual qualitative detection of THC, COC, AMP, MET, OPI2000 with OX, SG, pH adulterant tests
JANT PHARMACAL CORPORATION
DS84S625
In Commercial Distribution

  • 10763924084651 ()
  • 00763924084654 ()
DS84S625

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