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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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23andMe Personal Genome Service® (PGS) Includes : Carrier Status Report Genetic Health Risk Reports Cancer Predisposition Risk Assessment System (BRCA1/BRCA2 Selected Variants, MUTYH-Associated Polyposis(MAP)) Pharmacogenetics Reports
23ANDME, INC.
YouDot
Not in Commercial Distribution

  • 00859462006279 ()


  • Human genomic analysis interpretive software
23andMe Personal Genome Service® (PGS) Includes : Carrier Status Report Genetic Health Risk Reports Cancer Predisposition Risk Assessment System (BRCA1/BRCA2 Selected Variants, MUTYH-Associated Polyposis(MAP))
23ANDME, INC.
YouDot
Not in Commercial Distribution

  • 00859462006118 ()
n/a

  • Human genomic analysis interpretive software
Personal Genome Service (Genetic Reports)
23ANDME, INC.
YouDot
Not in Commercial Distribution

n/a

  • Human genomic analysis interpretive software
No Description
SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.
Scansys TA517
In Commercial Distribution

  • 06945087505175 ()


  • Eye anterior segment analyser
HexaVue IP In-Light Camera Control Feature
BLACK DIAMOND VIDEO, INC.
HexaVue IP
In Commercial Distribution

  • 00724995220594 ()
XQHPILCC

  • Operating room audiovisual data/device management system application software
HexaVue IP Surgical Light Control Feature
BLACK DIAMOND VIDEO, INC.
HexaVue IP
In Commercial Distribution

  • 00724995220587 ()
XQHPSLC

  • Operating room audiovisual data/device management system application software
The GlutenID Celiac Genetic Health Risk Test uses qualitative genotyping to detect clinically relevant variants in genomic DNA isolated from saliva collected from individuals 18 years of age or older with ORAcollect Dx OCD-100 for the purpose of reporting and interpreting Genetic Health Risks (GHR).
GENOMECONSULT, LLC
GlutenID
In Commercial Distribution

  • 00860013485405 ()


  • Human genomic analysis interpretive software
Talis EMR with +ACG is software intended to support patient care and billing documentation requirements and process control criteria defined by medical facility
Talis Clinical, LLC
Talis EMR with +ACG
In Commercial Distribution

  • 00860012608805 ()
Talis EMR with +ACG

  • Clinical management support software
Cornerstones4Care® Powered by Glooko Mobile Application displays and analyzes retrospective data from blood glucose meters, insulin pumps and continuous glucose monitors
GLOOKO, INC.
1.xx
Not in Commercial Distribution

  • 00855093008040 ()


  • Clinical management support software
The Glooko Mobile application for iOS and Android displays retrospective data that is captured from BG meters, insulin pumps and continuous glucose monitors (CGM)
GLOOKO, INC.
5.xx
In Commercial Distribution

  • 00855093008033 ()


  • Clinical management support software
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