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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9 Panel Cup Drug Test, AMP-BARB-BZO-COC-MET-MTD-OPI-PCP-THC-pH,SG,OX-CR,NI
EXPRESS DIAGNOSTICS INT'L, INC.
50905-DC
Not in Commercial Distribution

  • B29850905DC0 ()
50905-DC

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7 Panel Cup Drug Test, AMP-COC-MET-OPI-OXY-PCP-THC-pH,SG,OX-CR,NI
Express Diagnostic Int'l, Inc.
50715-DC
In Commercial Distribution

  • B29850715DC10 ()
50715-DC

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7 Panel Cup Drug Test, BARB-BZO-COC-MET-OPI-PCP-THC-pH,SG,OX-CR,NI
Express Diagnostic Int'l, Inc.
50705-DC
In Commercial Distribution

  • B29850705DC10 ()
50705-DC

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel Cup Drug Test, COC-MET-OPI-PCP-THC-pH,SG,OX-CR,NI
Express Diagnostic Int'l, Inc.
50505-DC
In Commercial Distribution

  • B29850505DC10 ()
50505-DC

  • 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/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
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
Home Drug Test 4 Panel COC/OPI/mAMP/THC
RITE AID CORPORATION
8024510
In Commercial Distribution

  • 00011822001663 ()


  • Cocaine/cocaine metabolite IVD, reagent
  • Opiate/opiate metabolite IVD, reagent
  • Methamphetamine-specific IVD, reagent
  • Cannabinoid/cannabinoid metabolite IVD, reagent
5 panel RapidTox with THC/COC/OPI2000/AMP/BZO
AMERICAN BIO MEDICA CORPORATION
10-5ZT-200
In Commercial Distribution

  • 10694644150459 ()
  • 10694644100454 ()
10-5ZT-200

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
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
Inspiration Ventilator System, model 7i with 12" Display Panel
Event Medical, Ltd.
Inspiration Ventilator System
In Commercial Distribution

  • B079EVM11000102US0 ()
F7300000-7i-S-US

  • General-purpose intensive-care ventilator
Inspiration Ventilator System, model 7i with 17" Display Panel
Event Medical, Ltd.
Inspiration Ventilator System
In Commercial Distribution

  • B079EVM11000101US0 ()
F7300000-7i-L-US

  • General-purpose intensive-care ventilator
12 Panel Cup Drug Test, AMP-BAR-BUP-BZO-COC-MDMA-MET-MTD-OPI300-OXY-PCP-THC-pH,SG,OX-CR,NI
CLINICAL REFERENCE LABORATORY, INC.
51205
Not in Commercial Distribution

  • 81781502512059 ()
51205

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
BD MAX™ CT/GC/TV 20-Day QC Panel
MICROBIOLOGICS INC.
8193 BD MAX™ CT/GC/TV 20-Day QC Panel
Not in Commercial Distribution

  • 70845357041080 ()
8193

  • Multiple-type sexually transmitted pathogen nucleic acid IVD, control
QC Sets and Panels: KWIK-STIK™ Yeast Identification Panel
MICROBIOLOGICS INC.
5252P
In Commercial Distribution

  • 70845357040168 ()
5252P

  • Multiple bacteria species culture isolate identification control IVD, kit
QC Sets and Panels: KWIK-STIK™ Anaerobe Identification Panel
MICROBIOLOGICS INC.
5246P
In Commercial Distribution

  • 70845357039926 ()
5246P

  • Multiple bacteria species culture isolate identification control IVD, kit
12 Panel Cup Drug Test, AMP-BAR-BZO-COC-MDMA-MET-MTD-OPI-OXY-PCP-TCA-THC-pH,SG,OX-CR,NI
CLINICAL REFERENCE LABORATORY, INC.
51215
Not in Commercial Distribution

  • 81781502512158 ()
51215

  • 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
CLINICAL REFERENCE LABORATORY, INC.
51125
Not in Commercial Distribution

  • 81781502511250 ()
51125

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
11 Panel Cup Drug Test, AMP-BAR-BZO-COC-MET-MTD-OPI-OXY-PCP-PPX-THC-pH,SG,OX-CR,NI
CLINICAL REFERENCE LABORATORY, INC.
51105
Not in Commercial Distribution

  • 81781502511052 ()
51105

  • 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
CLINICAL REFERENCE LABORATORY, INC.
51005
Not in Commercial Distribution

  • 81781502510055 ()
51005

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 Panel Cup Drug Test, AMP-BAR-BZO-COC-MET-MTD-OPI-OXY-PCP-pH,SG,OX-CR,NI
CLINICAL REFERENCE LABORATORY, INC.
50915
Not in Commercial Distribution

  • 81781502509158 ()
50915

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 Panel Cup Drug Test, AMP-BAR-BZO-COC-MET-MTD-OPI-PCP-THC-pH,SG,OX-CR,NI
CLINICAL REFERENCE LABORATORY, INC.
50905
Not in Commercial Distribution

  • 81781502509059 ()
50905

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7 Panel Cup Drug Test, AMP-COC-MET-OPI-OXY-PCP-THC-pH,SG,OX-CR,NI
CLINICAL REFERENCE LABORATORY, INC.
50715
Not in Commercial Distribution

  • 81781502507154 ()
50715

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7 Panel Cup Drug Test, BAR-BZO-COC-MET-OPI-PCP-THC-pH,SG,OX-CR,NI
CLINICAL REFERENCE LABORATORY, INC.
50705
Not in Commercial Distribution

  • 81781502507055 ()
50705

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel Cup Drug Test, COC-MET-OPI-PCP-THC-pH,SG,OX-CR,NI
CLINICAL REFERENCE LABORATORY, INC.
50505
Not in Commercial Distribution

  • 81781502505051 ()
50505

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

  • 10816490024375 ()
  • 00816490024378 ()
  • 20816490024372 ()
HCDOAEC-6125S

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

  • 20816490023481 ()
  • 10816490023484 ()
  • 00816490023487 ()
HCDOAV-275

  • 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
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
5 Panel DOA Test clear Round Cup With Clicker;
Healgen Scientific Limited Liability Company
HCDOAV-955
Not in Commercial Distribution

  • 20816490021661 ()
  • 10816490021664 ()
  • 00816490021667 ()
HCDOAV-955

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel DOA Test clear Round Cup With Clicker;
Healgen Scientific Limited Liability Company
HCDOAV-9125T
In Commercial Distribution

  • 20816490021654 ()
  • 10816490021657 ()
  • 00816490021650 ()
HCDOAV-9125T

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel DOA Test clear Round Cup With Clicker;
Healgen Scientific Limited Liability Company
HCDOAV-3125
In Commercial Distribution

  • 20816490021630 ()
  • 10816490021633 ()
  • 00816490021636 ()
HCDOAV-3125

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel DOA Test clear Round Cup With Clicker;
Healgen Scientific Limited Liability Company
HCDOAV-855
In Commercial Distribution

  • 20816490021623 ()
  • 10816490021626 ()
  • 00816490021629 ()
HCDOAV-855

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel DOA Test clear Round Cup With Clicker;
Healgen Scientific Limited Liability Company
HCDOAV-454
In Commercial Distribution

  • 20816490021616 ()
  • 10816490021619 ()
  • 00816490021612 ()
HCDOAV-454

  • 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
12 Panel DOA Test clear Round Cup With Clicker;
Healgen Scientific Limited Liability Company
HCDOAV-6124
In Commercial Distribution

  • 20816490020015 ()
  • 10816490020018 ()
  • 00816490020011 ()
HCDOAV-6124

  • 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
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
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