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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 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)
The web based application for calculation pediatric urea hydrolysis rate as part of the BreathTek UBT Kit for H. pylori.
MERIDIAN BIOSCIENCE, INC.
2.0
In Commercial Distribution

  • 00840733101458 ()
BRTKCALC

  • Helicobacter pylori urease IVD, kit, chromogenic
The BreathTek UBT for H. pylori Kit (BreathTek UBT Kit) is intended for use in the qualitative detection of urease associated with H. pylori in the human stomach and is indicated as an aid in the initial diagnosis and post-treatment monitoring of H. pylori infection in adults, and pediatric patients 3 to 17 years old. The test may be used for monitoring treatment is used at least 4 weeks following completion of therapy. For there purposes, the system utilizes an Infrared Spectrophotometer for the measurement of the ration of 13CO2 to 12CO2 in breath samples, in clinical laboratories and point-of-care settings. The Pediatric Urea Hydrolysis Rate Calculation Application (pUHR-CA), provided as a web-based calculation program, is required to obtain pediatric test results. The BreathTek UBT Kit is for administration by the heath care professional, as ordered by a licensed health care practitioner.
MERIDIAN BIOSCIENCE, INC.
01
In Commercial Distribution

  • 00840733101434 ()
  • 00840733101441 ()
8209

  • Helicobacter pylori urease IVD, kit, chromogenic
No Description
GE MEDICAL SYSTEMS
M3-2 SP1 STD+
In Commercial Distribution

  • 00840682142038 ()


  • Stationary mammographic x-ray system, digital
Advance Suture 3-0 Silk C-6 Needle 18"
The Atlanta Dental Supply Company
AD00072
In Commercial Distribution

  • 00850455007389 ()
  • 10850455007386 ()


  • Silk suture
Advance Suture 4-0 Silk C-6 Needle 18"
The Atlanta Dental Supply Company
AD00066
In Commercial Distribution

  • 00850455007341 ()
  • 10850455007348 ()


  • Silk suture
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