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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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No Description
DRAEGER MEDICAL SYSTEMS, INC.
MS16161
In Commercial Distribution

  • 04049098005470 ()


  • Electrocardiographic lead set, reusable
No Description
DRAEGER MEDICAL SYSTEMS, INC.
MS16230
In Commercial Distribution

  • 04049098005432 ()


  • Electrocardiographic lead set, reusable
No Description
DRAEGER MEDICAL SYSTEMS, INC.
MS28559
In Commercial Distribution

  • 04049098001625 ()


  • Electrocardiographic lead set, reusable
No Description
Roche Diagnostics GmbH
07398000160
In Commercial Distribution

  • 04015630942695 ()
07398000160

  • Troponin T IVD, kit, enzyme immunoassay (EIA)
No Description
AMPLITUDE SAS
1-01-07-4005
In Commercial Distribution

  • 03701089523820 ()


  • Uncoated knee tibia prosthesis, metallic
HemosIL Q.F.A. Thrombin (Bovine) - 5 mL
INSTRUMENTATION LABORATORY COMPANY
00020301700
In Commercial Distribution

  • 08426950573494 ()
  • 18426950573491 ()
00020301700

  • Fibrinogen assay (factor I) IVD, kit, clotting
1. 1x ENA 5 ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted ENA 5 ELISA Low Positive 4. 1x 1.2mL prediluted ENA 5 ELISA High Positive 5. 1x 50mL HRP Sample Diluent 6. 1x 25mL HRP Wash Concentrate, 40x concentrate 7. 1x 10mL HRP IgG Conjugate, (goat), anti-human IgG 8. 1x 10mL TMB Chromogen 9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid
INOVA DIAGNOSTICS, INC.
708610
In Commercial Distribution

  • 08426950544227 ()


  • Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, enzyme immunoassay (EIA)
Status Stick™ME/O/C/TH/P stick; 35 Test kit
PRINCETON BIOMEDITECH CORPORATION
DOA-151-35-00
In Commercial Distribution

  • 10743816001379 ()
DOA-151-35-00

  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
AccuSign® DOA 5 ME/O/C/TH/P card; 10 Test kit; CE
PRINCETON BIOMEDITECH CORPORATION
DOA-251-10-02
In Commercial Distribution

  • 10743816000389 ()
DOA-251-10-02

  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
AccuSign® DOA 5 ME/O/C/TH/P card; 35 Test kit; CE
PRINCETON BIOMEDITECH CORPORATION
DOA-251-35-02
In Commercial Distribution

  • 10743816000372 ()
DOA-251-35-02

  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
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