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
Diamond Diagnostics Inc.
OY-MU8267D
In Commercial Distribution

  • 00811403017041 ()


  • Multiple clinical chemistry analyser IVD, laboratory
No Description
Sarstedt Aktiengesellschaft & Co.KG
72.737.992
In Commercial Distribution

  • 04038917195126 ()
  • 04038917120197 ()
72.737.992

  • Assay container IVD, single-use
The PE Mix Reagent Module acts as a communication link with up to four reservoirs that house the test reagents as the Primer Extension Reaction is part of AvertD™, a prescription, qualitative genotyping test used to detect and identify 15 genetic polymorphisms in genomic DNA.
AUTOGENOMICS, INC
03-6560-01
In Commercial Distribution

  • 30850009370243 ()
  • 10850009370249 ()
03-6560-01

  • Opioid use disorder (OUD) genotyping IVD, kit, nucleic acid technique (NAT)
The Amplification Mix provides the reagent for the PCR amplification of the DNA sample as part of AvertD™, a prescription, qualitative genotyping test used to detect and identify 15 genetic polymorphisms in genomic DNA.
AUTOGENOMICS, INC
03-7560-01
In Commercial Distribution

  • 30850009370250 ()
  • 10850009370256 ()
03-7560-01

  • Opioid use disorder (OUD) genotyping IVD, kit, nucleic acid technique (NAT)
No Description
BISCO INC.
F-6102
Not in Commercial Distribution

  • D757F61020 ()

  • sixe text
F-6102

  • Dentine bonding agent/set
No Description
BISCO INC.
F-6100D
Not in Commercial Distribution

  • D757F6100D1 ()

  • sixe text
F-6100D

  • Dentine bonding agent/set
No Description
HYCOR BIOMEDICAL LLC
118877-001
In Commercial Distribution

  • 00816879023091 ()


  • General laboratory container, reusable
No Description
Lonza Walkersville, Inc.
15-1007J
In Commercial Distribution

  • 00840075403197 ()
15-1007J

  • Ex vivo cell culture medium
Bone Cement Mixing and Delivery System
SUMMIT MEDICAL LIMITED
C703
In Commercial Distribution

  • 25060238200237 ()
  • 15060238200230 ()
  • 35060238200234 ()


  • Orthopaedic cement preparation/delivery kit
Kit of 12 Unyvero M1 Master Mix Tubes, to be used with Unyvero LRT Cartridges
Curetis GmbH
M1 Master Mix Tube Kit
Not in Commercial Distribution

  • 04260364750041 ()
10020

  • DNA amplification enzyme reagent IVD
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