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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STAT II DOA 6 in 1 CLIA Waived Test Cup W/AD, 25Pcs/Box BZO/COC/mAMP/MOR/OXY/THC
MICRO DISTRIBUTING, L.C
STATⅡ-6167
In Commercial Distribution

  • 00816036021830 ()
  • 00816036021847 ()
STATⅡ-6167

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT DOA 8 in 1 Test Cup W/AD, 25Pcs/Box AMP/BZO/COC/mAMP/MOR/MTD/OXY/THC/PH-SG-OX
MICRO DISTRIBUTING, L.C
SCP-2387-A
In Commercial Distribution

  • 00816036021342 ()
  • 00816036021526 ()
SCP-2387-A

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

  • 00816036020918 ()
  • 00816036021120 ()
STATⅡ-21107

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT II DOA 5 in 1 Test Cup W/AD, 25Pcs/Box AMP/COC/mAMP/OPI/THC+pH,SG,OX
MICRO DISTRIBUTING, L.C
STATⅡ-1257-A
In Commercial Distribution

  • 00816036020819 ()
  • 00816036021021 ()
STATⅡ-1257-A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
STAT DOA 9 in 1 CLIA Waived Test Dipcard, 25Pcs/Box AMP/BAR/BZO/COC/mAMP/MTD/OPI/PCP/THC
MICRO DISTRIBUTING, L.C
SDP-194
In Commercial Distribution

  • 00816036020338 ()
  • 00816036020727 ()
SDP-194

  • 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 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
u-CardTM Drug Test Screen 12 Panel Test Card AMP/BAR/BUP/BZO/COC/MET/MDMA/MTD/MOP/OXY/PCP/THC
UCP BIOSCIENCES, INC.
U-DOA-20124
In Commercial Distribution

  • 20817038022218 ()
  • 10817038022211 ()
  • 00817038022214 ()
U-DOA-20124

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

  • 20817038022089 ()
  • 10817038022082 ()
  • 00817038022085 ()
U-MCUP-13104

  • 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
UCP BIOSCIENCES, INC.
ID-CP10
In Commercial Distribution

  • 20817038021662 ()
  • 10817038021665 ()
  • 00817038021668 ()
ID-CP10

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel Drug Test Cup (COC/THC/MOP/AMP/MET/BZO/MTD/OXY/MDMA/BUP) with Adulteration strip (S.G./CRE/pH)
UCP BIOSCIENCES, INC.
UCC-10-1MLA-CLIA
In Commercial Distribution

  • 20817038021044 ()
  • 10817038021047 ()
  • 00817038021040 ()
UCC-10-1MLA-CLIA

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel Drug Test Cup COC/THC/MOP/AMP/MET/BZO/MTD/OXY/MDMA/BUP with Adulteration strip (S.G./CRE/pH)
UCP BIOSCIENCES, INC.
UCC-10-1MLA-CLIA
In Commercial Distribution

  • 20817038020993 ()
  • 10817038020996 ()
  • 00817038020999 ()
UCC-10-1MLA-CLIA

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10-Panel Drug Test Cup COC/THC/MOP/AMP/MET/BZO/MTD/OXY/MDMA/BUP with Adulteration strip (S.G./CRE/pH)
UCP BIOSCIENCES, INC.
UCC-10-1MA-CLIA
In Commercial Distribution

  • 20817038020948 ()
  • 10817038020941 ()
  • 00817038020944 ()
UCC-10-1MA-CLIA

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
UDOA-12CE-0712-01 (Ox/Cr/pH)+<BUP>+(OXY/PPX)+(mAMP/MOP/PCP)+(BZO/MTD/BAR)+(AMP/COC/THC)MULTI-DRUG previous (GTIN 10869419000233)
Quest Diagnostics
UDOA-12CE-0712-01
In Commercial Distribution

  • 00869419000236 ()
  • 30869419000237 ()
DUE-1127-051-19-ONW504A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
13-Panel T-Cup Compact without THC; AMP500,BAR,BUP,BZO,COC150,MDMA,MET500,MOP,MTD,OXY,PCP,PPX,TCA with 3AD
WONDFO USA CO., LTD.
CDOA-L9135NTA3
In Commercial Distribution

  • 10816862023296 ()
  • 00816862023299 ()
  • 00816862023305 ()
CDOA-L9135NTA3

  • 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 / 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 / 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
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
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 / 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: 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
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