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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, Inc. Personal Genome Service®(PGS) - 00859462006279

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, Inc. Personal Genome Service®(PGS) - 00859462006262

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

  • 00859462006262 ()


  • Human genomic analysis interpretive software

23andMe, Inc. Personal Genome Service®(PGS) - 00859462006118

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

23andMe, Inc. Personal Genome Service®(PGS) - 00859462006095

23andMe Personal Genome Service® (PGS) Includes : Carrier Status Report Genetic Health Risk Reports BRCA1/BRCA2 (Selected Variants)
23ANDME, INC.
YouDot
Not in Commercial Distribution

  • 00859462006095 ()
n/a

  • Human genomic analysis interpretive software

23andMe, Inc. Personal Genome Service®(PGS) - 00859462006026

Personal Genome Service (Genetic Reports)
23ANDME, INC.
YouDot
Not in Commercial Distribution

n/a

  • Human genomic analysis interpretive software

ScanPoint® - 00879123006134

No Description
VERATHON INC
QuickPrint
In Commercial Distribution

  • 00879123006134 ()
0900-1238

  • Ultrasound imaging system application software

ScanPoint® - 00879123006127

No Description
VERATHON INC
ScanPoint®
In Commercial Distribution

  • 00879123006127 ()


  • Ultrasound imaging system application software

ScanPoint® - 00879123004239

No Description
VERATHON INC
ScanPoint Local Client
In Commercial Distribution

  • 00879123004239 ()
0900-1009

  • Ultrasound imaging system application software

Cornerstones4Care® Powered by Glooko Mobile Application - 00855093008040

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

Glooko Mobile Application - 00855093008033

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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