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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DOA 10 in 1 Test Dipcard, 25Pcs/Box Clia Waived AMP/BARB/BZO/COC/mAMP/MTD/OPI/PCP/TCA/THC
W.H.P.M. INC.
CW1104
In Commercial Distribution

  • 00841824102910 ()
  • 00841824100732 ()
CW1104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 10 in 1 Test Dipcard, 25Pcs/Box Clia Waived AMP/BARB/BZO/COC/mAMP/MTD/OPI/PCP/TCA/THC
W.H.P.M. INC.
W1104RD
In Commercial Distribution

  • 00841824102286 ()
  • 00841824100732 ()
W1104RD

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 5 in 1 Test ECO III Cup W/AD, 25Pcs/Box Clia Waived COC/mAMP/OPI/PCP/THC/PH-SG-OX
W.H.P.M. INC.
ECOⅢ-354 W/AD
In Commercial Distribution

  • 00841824101999 ()
  • 00841824101418 ()
ECOⅢ-354W/AD

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 10 in 1 Test Cup, 25Pcs/Box Clia Waived AMP/BARB/BZO/COC/mAMP/MDMA/MTD/OPI/PCP/THC
W.H.P.M. INC.
WCUP3104
In Commercial Distribution

  • 00841824101180 ()
  • 00841824101548 ()
WCUP3104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 6 in 1 Test ECO Cup W/AD, 25Pcs/Box Clia Waived AMP/BZO/COC/mAMP/OPI/THC/PH-SG-OX
W.H.P.M. INC.
WECCUP264 W/AD
In Commercial Distribution

  • 00841824101159 ()
  • 00841824101517 ()
WECCUP264 W/AD

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 5 in 1 Test ECO III Cup W/AD, 25Pcs/Box, CLIA Waived AMP/COC/mAMP/OPI/THC/PH-SG-OX
W.H.P.M. INC.
ECOⅢ-254 W/AD
In Commercial Distribution

  • 00841824101067 ()
  • 00841824101425 ()
ECOⅢ-254 W/AD

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 5 in 1 Test ECO II Cup W/ AD, 25Pcs/Box, CLIA Waived, AMP/COC/OPI/PCP/THC/CR-NI-OX-PH-SG
W.H.P.M. INC.
ECOII-154 W/AD9
In Commercial Distribution

  • 00841824101050 ()
  • 00841824100992 ()
ECOII-154 W/AD9P

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 5 in 1 Test ECO II Cup W/AD, 25Pcs/Box Clia Waived AMP/COC/mAMP/OPI/THC/PH-SG-OX
W.H.P.M. INC.
ECOⅡ-254 W/AD
In Commercial Distribution

  • 00841824100985 ()
  • 00841824101340 ()
ECOⅡ-254 W/AD

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 5 in 1 Test ECO II Cup W/ AD, 25Pcs/Box, CLIA Waived, AMP/BZO/COC/OPI/THC/CR-NI-PH-OX-SG
W.H.P.M. INC.
ECOII-754 W/AD9
In Commercial Distribution

  • 00841824100923 ()
  • 00841824100015 ()
ECOII-754 W/AD9P

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
8 Panel test cup, (OXY/MDMA)+(PCP/AMP1000)+COC150+MET500+OPI2000+THC with Cr, Ni, pH, Bl, S.G. adulteration tests
AMEDITECH INC.
IMCA-8CM5
Not in Commercial Distribution

  • 00816565020281 ()
IMCA-8CM5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
8 panel test cup, (COC/THC)+AMP+BZ0+BUP+MET1000+MTD+OPI300 with Cr, Ni, pH, Bl, S.G. adulteration tests
AMEDITECH INC.
IMCA-8BB
Not in Commercial Distribution

  • 00816565020267 ()
IMCA-8BB

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Prime Screen® 12-Panel Card; 25 per box; AMP,BAR,BUP,BZO,COC,MDMA,MET,MOP,MTD,OXY,PCP,THC
WONDFO USA CO., LTD.
DWDOA-6125-25BX-A
In Commercial Distribution

  • 10816862026051 ()
  • 00816862026054 ()
  • 00816862026047 ()


  • 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
13-Panel T-Cup Compact; AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MOP,MTD,OXY,PCP,TCA,THC with CR/pH/S.G.
WONDFO USA CO., LTD.
CDOA-2135A3
In Commercial Distribution

  • 10816862026396 ()
  • 00816862026399 ()
  • 00816862026382 ()


  • 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
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 / 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: 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 / 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 / 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 / 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 / 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 / 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
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 / 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
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