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 / BUP / BZD / COC / M-AMP / OPI / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7207-17
In Commercial Distribution

  • M90107RD7207170 ()

  • Length: 74 Millimeter
07RD7207-17

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / COC / M-AMP / OPI / OXY / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7207-16
In Commercial Distribution

  • M90107RD7207160 ()

  • Length: 74 Millimeter
07RD7207-16

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BAR / BUP / BZD / COC / MTD / OPI / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7207-14
In Commercial Distribution

  • M90107RD7207140 ()

  • Length: 74 Millimeter
07RD7207-14

  • 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 / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7207-10
In Commercial Distribution

  • M90107RD7207100 ()

  • Length: 74 Millimeter
07RD7207-10

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BUP / BZD / COC / M-AMP / OPI / OXY / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7207-02
In Commercial Distribution

  • M90107RD7207020 ()

  • Length: 74 Millimeter
07RD7207-02

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 6 in 1 Test Cup, 25Pcs/Box; First Sign for Hemosure, CLIA Waived, AMP/BZO/COC/OPI/OXY/THC
HEMOSURE INC.
FSCCUP-3864
In Commercial Distribution

  • 00817763022428 ()
  • 00817763022411 ()
FSCCUP-3864

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 6 in 1 Test Cup, 25Pcs/Box; First Sign for Hemosure, CLIA Waived AMP/BZO/COC/MOR/OXY/THC
HEMOSURE INC.
FSCCUP-6664
In Commercial Distribution

  • 00817763021971 ()
  • 00817763021995 ()
FSCCUP-6664

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 5 in 1 Test Dip card, 25Pcs/Box; First Sign for Hemosure; CLIA Waived AMP/BZO/COC/OPI/THC
HEMOSURE INC.
FSCDIP754
In Commercial Distribution

  • 00817763021643 ()
  • 00817763021667 ()
FSCDIP754

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 6 in 1 Test Dipcard, 25Pcs/Box; First Sign for Hemosure; CLIA Waived BZO/COC/MOR/MTD/OXY/THC
HEMOSURE INC.
FSCDIP1664
In Commercial Distribution

  • 00817763020707 ()
  • 00817763021391 ()
FSCDIP1664

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 6 in 1 Test Dipcard, 25Pcs/Box; First Sign for Hemosure; CLIA Waived AMP/COC/MTD/OPI/OXY/THC
HEMOSURE INC.
FSCDIP5964
In Commercial Distribution

  • 00817763020653 ()
  • 00817763021346 ()
FSCDIP5964

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 6 in 1 Test Cup, 25Pcs/Box; First Sign for Hemosure; CLIA Waived AMP/COC/mAMP/MOR/PCP/THC
HEMOSURE INC.
FSCCUP-3464
In Commercial Distribution

  • 00817763020639 ()
  • 00817763021308 ()
FSCCUP-3464

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 6 in 1 Test Cup, 25Pcs/Box; First Sign for Hemosure; CLIA Waived BZO/COC/mAMP/OPI/OXY/THC
HEMOSURE INC.
FSCCUP-564
In Commercial Distribution

  • 00817763020622 ()
  • 00817763021292 ()
FSCCUP-564

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 6 in 1  Test Cup, 25Pcs/Box; First Sign for Hemosure; CLIA Waived AMP/BZO/COC/mAMP/OPI/THC
HEMOSURE INC.
FSCCUP-264
In Commercial Distribution

  • 00817763020615 ()
  • 00817763021285 ()
FSCCUP-264

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 5 in 1 Test Dip card, 25Pcs/Box; First Sign for Hemosure; CLIA Waived AMP/COC/MTD/OPI/THC
HEMOSURE INC.
FSCDIP4854
In Commercial Distribution

  • 00817763020608 ()
  • 00817763021278 ()
FSCDIP4854

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 5 in 1 Test Dip card, 25Pcs/Box; First Sign for Hemosure; CLIA Waived BZO/COC/mAMP/OPI/THC
HEMOSURE INC.
FSCDIP654
In Commercial Distribution

  • 00817763020585 ()
  • 00817763021254 ()
FSCDIP654

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 5 in 1 Test Dip card, 25Pcs/Box; First Sign for Hemosure; CLIA Waived COC/mAMP/OPI/PCP/THC
HEMOSURE INC.
FSCDIP354
In Commercial Distribution

  • 00817763020578 ()
  • 00817763021247 ()
FSCDIP354

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 5 in 1 Test Dip card, 25Pcs/Box; First Sign for Hemosure; CLIA Waived AMP/COC/mAMP/OPI/THC
HEMOSURE INC.
FSCDIP254
In Commercial Distribution

  • 00817763020561 ()
  • 00817763021230 ()
FSCDIP254

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 5 in 1 Test Dip card, 25Pcs/Box; First Sign for Hemosure; CLIA Waived AMP/COC/OPI/PCP/THC
HEMOSURE INC.
FSCDIP154
In Commercial Distribution

  • 00817763020554 ()
  • 00817763021223 ()
FSCDIP154

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
T-Cup® Compact Multi-Drug Urine Test Cup <AMP, BAR, BUP, BZO, COC, MDMA, MET500, MOP, MTD, OXY, PCP, TCA, THC>
Instant Technologies, Inc.
ACDOA-10135
In Commercial Distribution

  • 00817405021024 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP/BAR/BUP/BZO/COC/EDDP/MDMA/MET/MOR/MTD/OXY/PCP/TCA/THC/(Ox/SG/pH)/(Cr/Ni/Gl)
ADVIN BIOTECH, INC.
ABCupC-14-01
In Commercial Distribution

  • B115ABCUPC14011 ()
  • B115ABCUPC14010 ()
ABCupC-14-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP/BAR/BUP/BZO/COC/EDDP/MDMA/MET/MOR/MTD/OXY/PCP/TCA/THC/(Ox/SG/pH)/(Cr/Ni/Gl)
ADVIN BIOTECH, INC.
ABCardC-14-01
In Commercial Distribution

  • B115ABCARDC14011 ()
  • B115ABCARDC14010 ()
ABCardC-14-01

  • 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 / THC
RAPID DIAGNOSTICS INC
07RD7113-01
In Commercial Distribution

  • 00817830020500 ()

  • Height: 74 Millimeter
07RD7113-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BUP / BZD / COC / M-AMP / OPI / OXY / THC
RAPID DIAGNOSTICS INC
07RD7113-02
In Commercial Distribution

  • 00817830020517 ()

  • Height: 74 Millimeter
07RD7113-02

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / COC / MET / OPI / OXY / THC
RAPID DIAGNOSTICS INC
07RD-7113-03
In Commercial Distribution

  • 00817830022719 ()

  • Length: 75 Millimeter
07RD-7113-03

  • 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 / MET / OPI / OXY / THC
RAPID DIAGNOSTICS INC
07RD-7070-11
In Commercial Distribution

  • 00817830022696 ()

  • Length: 75 Millimeter
07RD-7070-11

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BUP / BZD / COC / M-AMP / OPI / OXY / THC
RAPID DIAGNOSTICS INC
07RD-7070-15
In Commercial Distribution

  • 00817830022665 ()

  • Length: 75 Millimeter
07RD-7070-15

  • 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 / PCP / THC
RAPID DIAGNOSTICS INC
07RD7070-08
In Commercial Distribution

  • 00817830022078 ()

  • Length: 75 Millimeter
07RD7070-08

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BZD / COC / M-AMP / MTD / OPI / OXY / THC
RAPID DIAGNOSTICS INC
07RD7070-06
In Commercial Distribution

  • 00817830022054 ()

  • Length: 75 Millimeter
07RD7070-06

  • 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-II/ THC
RAPID DIAGNOSTICS INC
07RD7070-05A
In Commercial Distribution

  • 00817830022047 ()

  • Length: 75 Millimeter
07RD7070-05A

  • 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 / THC
RAPID DIAGNOSTICS INC
07RD7070-05
In Commercial Distribution

  • 00817830022030 ()

  • Length: 75 Millimeter
07RD7070-05

  • 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 / MTD / OPI-II / THC
RAPID DIAGNOSTICS INC
07RD7070-04A
In Commercial Distribution

  • 00817830022023 ()

  • Length: 75 Millimeter
07RD7070-04A

  • 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 / THC
RAPID DIAGNOSTICS INC
07RD7070-04
In Commercial Distribution

  • 00817830022016 ()

  • Length: 75 Millimeter
07RD7070-04

  • 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 / OPI-II / THC
RAPID DIAGNOSTICS INC
07RD7070-03A
In Commercial Distribution

  • 00817830022009 ()

  • Length: 75 Millimeter
07RD7070-03A

  • 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 / OPI / THC
RAPID DIAGNOSTICS INC
07RD7070-03
In Commercial Distribution

  • 00817830021996 ()

  • Length: 75 Millimeter
07RD7070-03

  • 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-II/ THC
RAPID DIAGNOSTICS INC
07RD7070-02A
In Commercial Distribution

  • 00817830021989 ()

  • Length: 75 Millimeter
07RD7070-02A

  • 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 / THC
RAPID DIAGNOSTICS INC
07RD7070-02
In Commercial Distribution

  • 00817830021972 ()

  • Length: 75 Millimeter
07RD7070-02

  • 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 / OPI / THC
RAPID DIAGNOSTICS INC
07RD-7070-13
In Commercial Distribution

  • 00817830022832 ()

  • Length: 75 Millimeter
07RD-7070-13

  • 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 / OPI / OXY / THC
RAPID DIAGNOSTICS INC
07RD-7070-14
In Commercial Distribution

  • 00817830022795 ()

  • Length: 75 Millimeter
07RD-7070-14

  • 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-II/ PCP / THC
RAPID DIAGNOSTICS INC
07RD7070-01A
In Commercial Distribution

  • 00817830021965 ()

  • Length: 75 Millimeter
07RD7070-01A

  • 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 / PCP / THC
RAPID DIAGNOSTICS INC
07RD7070-01
In Commercial Distribution

  • 00817830021958 ()

  • Length: 75 Millimeter
07RD7070-01

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