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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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Cath to Generator CBL Sterile
Biosense Webster Inc
D133701
In Commercial Distribution

  • 10846835010121 ()
D133701

  • Electrical-only medical device connection cable, reusable
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)
The Tube consists of BioFilmChip Microarray made of a polyester film coated with proprietary multi-layer components designed for DNA analysis as part of AvertD™, a prescription, qualitative genotyping test used to detect and identify 15 genetic polymorphisms in genomic DNA.
AUTOGENOMICS, INC
03-5560-01
In Commercial Distribution

  • 10850009370232 ()
03-5560-01

  • Opioid use disorder (OUD) genotyping IVD, kit, nucleic acid technique (NAT)
Buccal Sample Collection Kit for use with AvertD™, a prescription, qualitative genotyping test used to detect and identify 15 genetic polymorphisms in genomic DNA.
AUTOGENOMICS, INC
12-0610-01
In Commercial Distribution

  • 10850009370225 ()
12-0610-01

  • Oral/upper respiratory tract specimen collection kit IVD, clinical
The BioFilmChip Microarray consists of a polyester film coated with proprietary multi-layer components designed for DNA analysis as part of AvertD™, a prescription, qualitative genotyping test used to detect and identify 15 genetic polymorphisms in genomic DNA.
AUTOGENOMICS, INC
03-1560-01
In Commercial Distribution

  • 10850009370218 ()
  • 30850009370212 ()
03-1560-01

  • Opioid use disorder (OUD) genotyping IVD, kit, nucleic acid technique (NAT)
The Intellipac 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
03-2560-01
In Commercial Distribution

  • 10850009370201 ()
  • 30850009370205 ()
03-2560-01

  • 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
03-3560-01
In Commercial Distribution

  • 10850009370195 ()
  • 30850009370199 ()
03-3560-01

  • Opioid use disorder (OUD) genotyping IVD, kit, nucleic acid technique (NAT)
ONESTEP PEDIATRIC CPR ELECTRODE, GEMINI, 8/CASE
Zoll Medical Corporation
8900-000381-01
In Commercial Distribution

  • 10847946027015 ()


  • Multifunction cardiac electrode, paediatric
8.5 FR VARIPULSE™ Bi-Directional Catheter
Biosense Webster Inc
D141201
In Commercial Distribution

  • 10846835025460 ()
D141201

  • Cardiac irreversible electroporation system catheter
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