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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5 Panel Cup Drug Test, BZO-COC-MET-OPI300-THC-ph,SG,OX-CR,NI
EXPRESS DIAGNOSTICS INT'L, INC.
60536-5
Not in Commercial Distribution

  • B2986053650 ()
60536-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel Dip Drug Test, AMP-BARB-BUP-BZO-COC-MDMA-MET500-MTD-OPI300-OXY-PCP-THC-pH,SG,OX-CR,NI
Express Diagnostic Int'l, Inc.
31234-5
In Commercial Distribution

  • B2983123450 ()
31234-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel Dip Drug Test, AMP-BAR-BUP-BZO-COC-MDMA-MET-MTD-OPI300-OXY-PPX-THC-pH,SG,OX-CR,NI
EXPRESS DIAGNOSTICS INT'L, INC.
31208-5
Not in Commercial Distribution

  • B2983120850 ()
31208-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel Dip Drug Test, AMP-BAR-BZO-COC-MDMA-MET-MTD-OPI300-OXY-PCP-PPX-THC-pH,SG,OX-CR,NI
EXPRESS DIAGNOSTICS INT'L, INC.
31202-5
Not in Commercial Distribution

  • B2983120250 ()
31202-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
11 Panel Dip Drug Test, AMP-BARB-BUP-BZO-COC-MDMA-MET-MTD-OPI300-OXY-THC-pH,SG,OX-CR,NI
Express Diagnostic Int'l, Inc.
31135-5
In Commercial Distribution

  • B29831135510 ()
31135-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel Dip Drug Test, AMP-BAR-BZO-COC-MDMA-MTD-OPI-OXY-PCP-THC-pH,SG,OX-CR,NI
EXPRESS DIAGNOSTICS INT'L, INC.
31012-5
Not in Commercial Distribution

  • B2983101250 ()
31012-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 Panel Dip Drug Test, AMP-BUP-BZO-COC-MET-MTD-OPI300-OXY-THC-pH,SG,OX-CR,NI
EXPRESS DIAGNOSTICS INT'L, INC.
30970-5
Not in Commercial Distribution

  • B2983097050 ()
30970-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
OralTox 6 Panel - COC/MET/OPI/OXY/PCP/THC
PREMIER BIOTECH, INC
OT80622
Not in Commercial Distribution

  • B313OT806221 ()
  • B313OT806220 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6 Panel OralTox - AMP/COC/MET/OPI/OXY/THC
PREMIER BIOTECH, INC
OT80605
Not in Commercial Distribution

  • B313OT806051 ()
  • B313OT806050 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6 Panel OralTox - AMP/COC/MET/OPI/PCP/THC
PREMIER BIOTECH, INC
OT80602
Not in Commercial Distribution

  • B313OT806021 ()
  • B313OT806020 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel OralTox Device - COC/MET/OPI/OXY/THC
PREMIER BIOTECH, INC
OT80509
Not in Commercial Distribution

  • B313OT805091 ()
  • B313OT805090 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel Cup Drug Test, AMP-BZO-COC-OPI-THC-pH,SG,OX-CR,NI
EXPRESS DIAGNOSTICS INT'L, INC.
65520-5
Not in Commercial Distribution

  • B2986552050 ()
65520-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel Cup Drug Test, BZO-COC-MET-OPI-THC-pH,SG,OX-CR,NI
Express Diagnostic Int'l, Inc.
65515-5
In Commercial Distribution

  • B29865515510 ()
65515-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel Cup Drug Test, BZO-COC-MET-OPI-THC-pH,SG,OX-CR,NI
EXPRESS DIAGNOSTICS INT'L, INC.
65515-5
Not in Commercial Distribution

  • B2986551550 ()
65515-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel Cup Drug Test, AMP-COC-OPI-PCP-THC-pH,SG,OX-CR,NI
EXPRESS DIAGNOSTICS INT'L, INC.
65505-5
Not in Commercial Distribution

  • B2986550550 ()
65505-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel Cup Drug Test, AMP-COC-MET-OPI-THC-pH,SG,OX-CR,NI
Express Diagnostic Int'l, Inc.
65500-5
In Commercial Distribution

  • B29865500510 ()
65500-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel Cup Drug Test, AMP-COC-MET-OPI-THC-pH,SG,OX-CR,NI
EXPRESS DIAGNOSTICS INT'L, INC.
65500-5
Not in Commercial Distribution

  • B2986550050 ()
65500-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel Cup Drug Test, AMP-BAR-BZO-COC-MDMA-MET-MTD-OPI300-OXY-PCP-PPX-THC-pH,SG,OX-CR,NI
EXPRESS DIAGNOSTICS INT'L, INC.
61202-5
Not in Commercial Distribution

  • B2986120250 ()
61202-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
11 Panel Cup Drug Test, AMP-BARB-BZO-COC-MDMA-MET500-MTD-OPI300-OXY-PCP-THC-pH,SG,OX-CR,NI
Express Diagnostic Int'l, Inc.
61129-5
In Commercial Distribution

  • B29861129510 ()
61129-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
11 Panel Cup Drug Test, AMP-BARB-BZO-COC-MDMA-MET500-MTD-OPI300-OXY-PCP-THC-pH,SG,OX-CR,NI
EXPRESS DIAGNOSTICS INT'L, INC.
61129-5
Not in Commercial Distribution

  • B2986112950 ()
61129-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel Cup Drug Test, BUP-BZO-COC-MDMA-MET-MTD-OPI300-OXY-PPX-THC-pH,SG,OX-CR,NI
EXPRESS DIAGNOSTICS INT'L, INC.
61057-5
Not in Commercial Distribution

  • B2986105750 ()
61057-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel Cup Drug Test, AMP-BUP-BZO-COC-MDMA-MET-MTD-OPI300-OXY-THC-pH,SG,OX-CR,NI
EXPRESS DIAGNOSTICS INT'L, INC.
61056-5
Not in Commercial Distribution

  • B2986105650 ()
61056-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel Cup Drug Test, AMP-BAR-BZO-COC-MDMA-MET-MTD-OPI-PCP-THC-pH,SG,OX-CR,NI
EXPRESS DIAGNOSTICS INT'L, INC.
61021-5
Not in Commercial Distribution

  • B2986102150 ()
61021-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel Cup Drug Test, AMP-BARB-BZO-COC-MET-MTD-OPI-OXY-PCP-THC-pH,SG,OX-CR,NI
Express Diagnostic Int'l, Inc.
61020-5
In Commercial Distribution

  • B29861020510 ()
61020-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel Cup Drug Test, AMP-BAR-BZO-COC-MET-MTD-OPI-OXY-PCP-THC-pH,SG,OX-CR,NI
EXPRESS DIAGNOSTICS INT'L, INC.
61020-5
Not in Commercial Distribution

  • B2986102050 ()
61020-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel Cup Drug Test, AMP-BAR-BZO-COC-MDMA-MET-OPI-OXY-PPX-THC-pH,SG,OX-CR,NI
EXPRESS DIAGNOSTICS INT'L, INC.
61010-5
Not in Commercial Distribution

  • B2986101050 ()
61010-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel Cup Drug Test, AMP-BZO-COC-MDMA-MET-MTD-OPI-OXY-PCP-THC-pH,SG,OX-CR,NI
EXPRESS DIAGNOSTICS INT'L, INC.
61006-5
Not in Commercial Distribution

  • B2986100650 ()
61006-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 Panel Cup Drug Test, AMP-BUP-BZO-COC-MET-MTD-OPI300-OXY-THC-pH,SG,OX-CR,NI
EXPRESS DIAGNOSTICS INT'L, INC.
60930-5
Not in Commercial Distribution

  • B2986093050 ()
60930-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 Panel Cup Drug Test, AMP-BARB-BZO-COC-MET-MTD-OPI-OXY-PCP-pH,SG,OX-CR,NI
Express Diagnostic Int'l, Inc.
60908-5
In Commercial Distribution

  • B2986090850 ()
60908-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
13 Panel Cup Drug Test, AMP-BARB-BUP-BZO-COC-MDMA-MET-MTD-OPI-OXY-PCP-TCA-THC-pH,SG,OX-CR,NI
Express Diagnostic Int'l, Inc.
61307-5
In Commercial Distribution

  • B2986130750 ()
61307-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel Cup Drug Test, AMP-BAR-BZO-COC-MET-MTD-OPI-OXY-PCP-PPX-TCA-THC-pH,SG,OX-CR,NI
EXPRESS DIAGNOSTICS INT'L, INC.
61243-5
Not in Commercial Distribution

  • B2986124350 ()
61243-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel Cup Drug Test, AMP-BAR-BUP-BZO-COC-MDMA-MET-MTD-OPI-OXY-TCA-THC-pH,SG,OX-CR,NI
EXPRESS DIAGNOSTICS INT'L, INC.
61211-5
Not in Commercial Distribution

  • B2986121150 ()
61211-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel Cup Drug Test, AMP-BAR-BUP-BZO-COC-MDMA-MET-MTD-OPI300-OXY-PPX-THC-pH,SG,OX-CR,NI
EXPRESS DIAGNOSTICS INT'L, INC.
61208-5
Not in Commercial Distribution

  • B2986120850 ()
61208-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel Cup Drug Test, AMP-BAR-BUP-BZO-COC-MET-MTD-OPI300-OXY-PCP-PPX-THC-pH,SG,OX-CR,NI
EXPRESS DIAGNOSTICS INT'L, INC.
61207-5
Not in Commercial Distribution

  • B2986120750 ()
61207-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
11 Panel Cup Drug Test, AMP-BARB-BUP-BZO-COC-MDMA-MET-MTD-OPI300-OXY-THC-pH,SG,OX-CR,NI
Express Diagnostic Int'l, Inc.
61121-5
In Commercial Distribution

  • B29861121510 ()
61121-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
11 Panel Cup Drug Test, AMP-BAR-BUP-BZO-COC-MDMA-MET-MTD-OPI300-OXY-THC-pH,SG,OX-CR,NI
EXPRESS DIAGNOSTICS INT'L, INC.
61121-5
Not in Commercial Distribution

  • B2986112150 ()
61121-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
11 Panel Cup Drug Test, AMP-BAR-BZO-COC-MDMA-MET-MTD-OPI-OXY-PCP-THC-pH,SG,OX-CR,NI
EXPRESS DIAGNOSTICS INT'L, INC.
61103-5
Not in Commercial Distribution

  • B2986110350 ()
61103-5

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel Preview Cup: AMP1000, COC300, MET1000, MOP300, OXY100
WONDFO USA CO., LTD.
PRE-PDOA-755
In Commercial Distribution

  • 10816862021803 ()
  • 00816862021806 ()
  • 00816862021813 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 panel test cup, BZO/COC/MET1000/OPI300/THC
AMEDITECH INC.
IMC-5MB300
Not in Commercial Distribution

  • 00816565020151 ()
IMC-5MB300

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 panel test cup, AMP/COC/MET1000/OPI2000/THC
AMEDITECH INC.
IMC-5M
Not in Commercial Distribution

  • 00816565020144 ()
IMC-5M

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 panel test cup, BZO300/COC300/MTD300/OPI300/THC50
AMEDITECH INC.
IMC-5BO3
Not in Commercial Distribution

  • 00816565020137 ()
IMC-5BO3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel DOA Test clear Round Cup With Clicker;
Healgen Scientific Limited Liability Company
HCDOAV-8105
In Commercial Distribution

  • 20816490022316 ()
  • 10816490022319 ()
  • 00816490022312 ()
HCDOAV-8105

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
8 Panel DOA Test clear Round Cup With Clicker
Healgen Scientific Limited Liability Company
HCDOAV-785
In Commercial Distribution

  • 20816490022163 ()
  • 10816490022166 ()
  • 00816490022169 ()
HCDOAV-785

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel DOA Test clear Round Cup With Clicker
Healgen Scientific Limited Liability Company
HCDOAV-10115S
In Commercial Distribution

  • 20816490022019 ()
  • 10816490022012 ()
  • 00816490022015 ()
HCDOAV-10115S

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7 Panel DOA Test clear Round Cup With Clicker
Healgen Scientific Limited Liability Company
HCDOAV-275S
In Commercial Distribution

  • 20816490021814 ()
  • 10816490021817 ()
  • 00816490021810 ()
HCDOAV-275S

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel DOA Test clear Round Cup With Clicker;
Healgen Scientific Limited Liability Company
HCDOAV-4105
In Commercial Distribution

  • 20816490021739 ()
  • 10816490021732 ()
  • 00816490021735 ()
HCDOAV-4105

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7 Panel DOA Test clear Round Cup With Clicker;
Healgen Scientific Limited Liability Company
HCDOAV-874
In Commercial Distribution

  • 20816490021722 ()
  • 10816490021725 ()
  • 00816490021728 ()
HCDOAV-874

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel DOA Test clear Round Cup With Clicker;
Healgen Scientific Limited Liability Company
HCDOAV-6125S
In Commercial Distribution

  • 20816490021593 ()
  • 10816490021596 ()
  • 00816490021599 ()
HCDOAV-6125S

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel DOA Test clear Round Cup With Clicker;
Healgen Scientific Limited Liability Company
HCDOAV-1104S
In Commercial Distribution

  • 20816490021586 ()
  • 10816490021589 ()
  • 00816490021582 ()
HCDOAV-1104S

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel DOA Test clear Round Cup With Clicker;
Healgen Scientific Limited Liability Company
HCDOAV-955
In Commercial Distribution

  • 20816490021418 ()
  • 10816490021411 ()
  • 00816490021414 ()
HCDOAV-955

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