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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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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
Insulin Insights™ is a glycemic management software support program designed to provide insulin dosing recommendations to the clinician in order to adjust and maintain blood glucose levels in insulin-dependent diabetic patients within a clinician determined target range. Insulin Insights™ evaluates a set of current and cumulative patient blood glucose values together with biometric information (including age, weight, height, and gender) and suggests changes (if necessary). Insulin Insights™ is designed for use by healthcare professionals. Insulin Insights™ is indicated for use in adults and pediatric patients ages 7 and above who weigh more than 36 lbs.
MELLITUS HEALTH, INC.
Version 1
In Commercial Distribution

  • 00860001009804 ()


  • Clinical management support 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
23ANDME, INC.
YouDot
Not in Commercial Distribution

  • 00859462006385 ()


  • 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
23ANDME, INC.
YouDot
Not in Commercial Distribution

  • 00859462006262 ()


  • Human genomic analysis interpretive software
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
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