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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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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)
No Description
MENICON CO.,LTD.
ACUVUE Abiliti
In Commercial Distribution

  • 00192538951364 ()


  • Orthokeratology contact lens
No Description
MENICON CO.,LTD.
ACUVUE Abiliti
In Commercial Distribution

  • 00192538951357 ()


  • Orthokeratology contact lens
No Description
MENICON CO.,LTD.
Wine Red
In Commercial Distribution

  • 00192538901086 ()


  • Orthokeratology contact lens
  • Rigid-gas-permeable corrective contact lens, extended-wear
Clinical Kit, SCD-PED
SEASTAR MEDICAL INCORPORATED
02-1006-01
In Commercial Distribution

  • G621021006011 ()
  • G62102100601 ()
02-1006-01

  • Apheresis system column, selective leukocyte adsorption
Cable Set
BOSTON SCIENTIFIC CORPORATION
M004PF61M499D
In Commercial Distribution

  • 00191506052447 ()
M004PF61M499D

  • Electrocardiographic lead set, reusable
  • Electrical-only medical device connection cable, reusable
Controller Clinician Kit
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
DB-5290
In Commercial Distribution

  • 00191506047290 ()
M365DB52900

  • Deep brain electrical stimulation system
Controller Patient Kit
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
DB-5590
In Commercial Distribution

  • 00191506047283 ()
M365DB55900

  • Deep brain electrical stimulation system
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