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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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Glooko Mobile Insulin Dosing System is an insulin dose calculator. The Glooko MIDS Web software is available for use by the prescribers on standard web browsers.
GLOOKO, INC.
18.x
In Commercial Distribution

  • 00855093008019 ()


  • Clinical management support software
Glooko Mobile Insulin Dosing System (MIDS) is an insulin dose calculator. The Glooko MIDS Mobile Application is only available to patients who have been prescribed MIDS by their heath care provider. The mobile application can be downloaded by patients from the Google Play Store for Android and from the Apple App Store for iOS operating systems.
GLOOKO, INC.
5.x
In Commercial Distribution

  • 00855093008002 ()


  • Clinical management support 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
No Description
EXACT SCIENCES CORPORATION
1.1
In Commercial Distribution

  • 00858637005901 ()


  • Laboratory instrument/analyser application software IVD
No Description
EXACT SCIENCES CORPORATION
1.7
In Commercial Distribution

  • 00858637005888 ()


  • Laboratory instrument/analyser application software IVD
No Description
EXACT SCIENCES CORPORATION
1.6
Not in Commercial Distribution

  • 00858637005826 ()


  • Laboratory instrument/analyser application software IVD
No Description
EXACT SCIENCES CORPORATION
2.1
In Commercial Distribution

  • 00858637005413 ()


  • Laboratory instrument/analyser application software IVD
No Description
EXACT SCIENCES CORPORATION
2.1
In Commercial Distribution

  • 00858637005406 ()


  • Laboratory instrument/analyser application software IVD
No Description
EXACT SCIENCES CORPORATION
2.1
In Commercial Distribution

  • 00858637005390 ()


  • Laboratory instrument/analyser application software IVD
No Description
EXACT SCIENCES CORPORATION
1.4
Not in Commercial Distribution

  • 00858637005352 ()


  • Laboratory instrument/analyser application software IVD
No Description
EXACT SCIENCES CORPORATION
2.1
In Commercial Distribution

  • 00858637005321 ()


  • Laboratory instrument/analyser application software IVD
No Description
EXACT SCIENCES CORPORATION
1.3
Not in Commercial Distribution

  • 00858637005277 ()


  • Laboratory instrument/analyser application software IVD
No Description
EXACT SCIENCES CORPORATION
2.0
Not in Commercial Distribution

  • 00858637005246 ()


  • Laboratory instrument/analyser application software IVD
No Description
EXACT SCIENCES CORPORATION
2.0
Not in Commercial Distribution

  • 00858637005239 ()


  • Laboratory instrument/analyser application software IVD
No Description
EXACT SCIENCES CORPORATION
2.0
Not in Commercial Distribution

  • 00858637005222 ()


  • Laboratory instrument/analyser application software IVD
No Description
EXACT SCIENCES CORPORATION
2.0
Not in Commercial Distribution

  • 00858637005215 ()


  • Laboratory instrument/analyser application software IVD
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, CYP2C19 Pharmacogenetic Report Update and medication insights, NonSyndromic Hearing Loss Carrier Status Report, Sickle Cell Carrier Status Report Update, Hereditary Prostate Cancer (HOXB13-Related), SLCO1B1 Pharmacogenetic Report Update and medication insight, BRCA1/BRCA2 (Selected Variants) report update
23ANDME, INC.
YouDot
In Commercial Distribution

  • 00859462006415 ()


  • Human genomic analysis interpretive software
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, SLCO1B1 Pharmacogenetic Report Update and medication insights, NonSyndromic Hearing Loss Carrier Status Report, Sickle Cell Carrier Status Report Update, Hereditary Prostate Cancer (HOXB13-Related), SLCO1B1 Pharmacogenetic Report Update and medication insight
23ANDME, INC.
YouDot
Not in Commercial Distribution

  • 00859462006408 ()


  • Human genomic analysis interpretive software
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, NonSyndromic Hearing Loss Carrier Status Report, Sickle Cell Carrier Status Report Update, Hereditary Prostate Cancer (HOXB13-Related)
23ANDME, INC.
YouDot
Not in Commercial Distribution

  • 00859462006392 ()


  • Human genomic analysis interpretive software
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