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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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Analytical Client - 00858637005215

No Description
EXACT SCIENCES CORPORATION
2.0
Not in Commercial Distribution

  • 00858637005215 ()


  • Laboratory instrument/analyser application software IVD

23andMe, Inc. Personal Genome Service®(PGS) - 00859462006415

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, Inc. Personal Genome Service®(PGS) - 00859462006408

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, Inc. Personal Genome Service®(PGS) - 00859462006392

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

23andMe, Inc. Personal Genome Service®(PGS) - 00859462006385

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, Inc. Personal Genome Service®(PGS) - 00859462006378

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
23ANDME, INC.
YouDot
Not in Commercial Distribution

  • 00859462006378 ()


  • Human genomic analysis interpretive software

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
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