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

n/a

  • 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
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
BT-001 (AspyreRx) is a prescription-only digital therapeutic device intended to provide cognitive behavioral therapy to treat patients 18 years or older with type 2 diabetes.
Better Therapeutics, Inc.
ma.1.0.0
In Commercial Distribution

  • 00860011146704 ()


  • Mental health/function therapeutic software, screen-viewed
A self-guided digital Acceptance and Commitment Therapy, a form of Cognitive Behavioral Therapy intended for the treatment of fibromyalgia symptoms. It is used by the patient at home or any out of clinic setting to reinforce their skills in acceptance and commitment therapy.
Swing Therapeutics, Inc.
1.2
In Commercial Distribution

  • 00860010446324 ()


  • Mental health/function therapeutic software, screen-viewed
A self-guided digital Acceptance and Commitment Therapy, a form of Cognitive Behavioral Therapy intended for the treatment of fibromyalgia symptoms. It is used by the patient at home or any out of clinic setting to build their skills in acceptance and commitment therapy.
Swing Therapeutics, Inc.
1.2
In Commercial Distribution

  • 00860010446317 ()


  • Mental health/function therapeutic software, screen-viewed
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