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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CYP450 2C9 drug metabolizing enzyme and VKORC1 genotyping system
AUTOGENOMICS, INC
03-3140-01
Not in Commercial Distribution

  • 00850009370181 ()
03-3140-01

  • Anticoagulant-resistance multiple genetic risk factor IVD, kit, nucleic acid technique (NAT)
CYP2C19 drug metabolyzing enzyme genotyping system
AUTOGENOMICS, INC
03-3220-01
Not in Commercial Distribution

  • 00850009370150 ()
03-3220-01

  • Cytochrome P450 (CYP450) gene polymorphism IVD, kit, multiplex
No Description
BIOARRAY SOLUTIONS LTD
800-00193
In Commercial Distribution

  • 10888234100645 ()
800-00193

  • Multiple blood group genotyping IVD, reagent
No Description
Sarstedt Aktiengesellschaft & Co.KG
72.737.992
In Commercial Distribution

  • 04038917195126 ()
  • 04038917120197 ()
72.737.992

  • Assay container IVD, single-use
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)
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)
No Description
Diamond Diagnostics Inc.
OY-MU8267D
In Commercial Distribution

  • 00811403017041 ()


  • Multiple clinical chemistry analyser IVD, laboratory
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
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