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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eSensor® Respiratory Viral Panel Cartridge Pouch (RVP) (8)
GENMARK DIAGNOSTICS, INC.
eSensor® Respiratory Viral Panel (RVP)
Not in Commercial Distribution

  • 00857167005092 ()
KT021620

  • Multiple-genus respiratory virus antigen IVD, kit, multiplex
Single Panel Cocaine urine drug test device with Timer
PHAMATECH, INCORPORATED
9073T
In Commercial Distribution

  • 00674033090736 ()


  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
CLIA Waived Morphine 300 ng/ml Test Panel (MOP)
Medical Disposables Corp
M-DMO-114
In Commercial Distribution

  • 00850969007325 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived Morphine 300 ng/ml Test Panel (MOP)
Medical Disposables Corp
M-DMO-114
In Commercial Distribution

  • 00850969007929 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
M-DOA-565 CLIA Waived 6 Panel Drug Test Card-(THC-COC-MOP-MET-BZO-OXY)
Medical Disposables Corp
M-DOA-565
In Commercial Distribution

  • 00851721007966 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
M-DOA-565 CLIA Waived 6 Panel Drug Test Card-(THC-COC-MOP-MET-BZO-OXY)
Medical Disposables Corp
M-DOA-565
In Commercial Distribution

  • 00851721007959 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
M-DOA-565 CLIA Waived 6 Panel Drug Test Card-(THC-COC-MOP-MET-BZO-OXY)
Medical Disposables Corp
M-DOA-565
In Commercial Distribution

  • 00851721007942 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived 2 Panel Drug Test Card (BUP/TCA)
Medical Disposables Corp
M-DOA-824
In Commercial Distribution

  • 00851721007850 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived 2 Panel Drug Test Card (BUP/TCA)
Medical Disposables Corp
M-DOA-824
In Commercial Distribution

  • 00851721007805 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
CLIA Waived Morphine 300 ng/ml Test Panel (MOP)
Medical Disposables Corp
M-DMO-114
In Commercial Distribution

  • 00851721007485 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
ATLAS Stim Headbox with Nihon Kohden passive side panel.
NEURALYNX, INC.
NK
In Commercial Distribution

  • 00867718000285 ()
31-0601-0077

  • Somatosensory electrical stimulation system
GOWN,SRI,XALT/BLKD,PANEL CVR,L4,GRN,XL
MEDLINE INDUSTRIES, INC.
SYN7804XL
In Commercial Distribution

  • 40888277172280 ()
  • 10888277172289 ()
SYN7804XL

  • Surgical gown, reusable
GOWN,SRI,XALT/BLKD,PANEL CVR,L4,GRN,M
MEDLINE INDUSTRIES, INC.
SYN7802M
In Commercial Distribution

  • 40888277172273 ()
  • 10888277172272 ()
SYN7802M

  • Surgical gown, reusable
Multi Drug Test Panel (4.43) - BZO300 MET1000 BUP10 OPI2000
BTNX Inc
D4.43-1P29-25
In Commercial Distribution

  • 00722066005101 ()
  • 10722066005108 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Illumena Neo Contrast Delivery System, Rackmount Powerpack Panel (Accessory)
Liebel-Flarsheim Company LLC
900606
In Commercial Distribution

  • 10746190004912 ()


  • Angiography contrast medium injection system, line-powered, stationary
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 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
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
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
5 Panel DOA Test clear Round Cup With Clicker;
Healgen Scientific Limited Liability Company
HCDOAV-145S
In Commercial Distribution

  • 20816490021937 ()
  • 10816490021930 ()
  • 00816490021933 ()
HCDOAV-145S

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6 Panel DOA Test clear Round Cup With Clicker;
Healgen Scientific Limited Liability Company
HCDOAV-1265
In Commercial Distribution

  • 20816490021876 ()
  • 10816490021879 ()
  • 00816490021872 ()
HCDOAV-1265

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7 Panel DOA Test clear Round Cup With Clicker;
Healgen Scientific Limited Liability Company
HCDOAV-975
In Commercial Distribution

  • 20816490021869 ()
  • 10816490021862 ()
  • 00816490021865 ()
HCDOAV-975

  • 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
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-4125
In Commercial Distribution

  • 20816490021487 ()
  • 10816490021480 ()
  • 00816490021483 ()
HCDOAV-4125

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel DOA Test clear Round Cup With Clicker;
Healgen Scientific Limited Liability Company
HCDOAV-4124
In Commercial Distribution

  • 20816490021470 ()
  • 10816490021473 ()
  • 00816490021476 ()
HCDOAV-4124

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel DOA Test clear Round Cup With Clicker;
Healgen Scientific Limited Liability Company
HCDOAV-3124
In Commercial Distribution

  • 20816490021463 ()
  • 10816490021466 ()
  • 00816490021469 ()
HCDOAV-3124

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