FDA.reportPublic FDA data

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

Primary DI
00859462006026
Brand
23andMe, Inc. Personal Genome Service®(PGS)
Company
23ANDME GENOMICS LLC
Model
YouDot
Catalog number
n/a
Device description
Personal Genome Service (Genetic Reports)
Published
2017-04-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PKBAutosomal Recessive Carrier Screening Gene Mutation Detection System
PTAGenetic Variant Detection And Health Risk Assessment System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PKBAutosomal Recessive Carrier Screening Gene Mutation Detection SystemImmunology2
PTAGenetic Variant Detection And Health Risk Assessment SystemImmunology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00862150000060PreviousGS10
00859462006026PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00862150000060008621500000608621500000600862150000060
00859462006026008594620060268594620060260859462006026

GMDN Terms#

Term, Definition table
TermDefinition
Human genomic analysis interpretive softwareAn interpretive software program intended to be used for the analysis and visualization of human genome data from in vitro diagnostic (IVD) results obtained through molecular genetic testing (e.g., whole genome, targeted genome, or exome analyses). It provides predictive and/or diagnostic information (e.g., gene-drug associations, congenital and/or acquired aneuploidy status, genotype-phenotype relationships) used by a professional in the assessment of patient adverse health condition risk, disease prevention, and/or health management, or for lifestyle guidance as pertains to a patient genomic profile. This software is not an IVD device.

Contacts#

Phone, Email table
PhoneEmail
1-800-239-5230customercare@23andme.com

Regulatory Flags#

DUNS number
144889067
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
0085946200641523andMe, Inc. Personal Genome Service®(PGS)YouDot2023-10-16
0085946200640823andMe, Inc. Personal Genome Service®(PGS)YouDot2023-07-19
0085946200639223andMe, Inc. Personal Genome Service®(PGS)YouDot2023-03-22
0085946200638523andMe, Inc. Personal Genome Service®(PGS)YouDot2023-01-25
0085946200637823andMe, Inc. Personal Genome Service®(PGS)YouDot2022-05-24
0085946200626223andMe, Inc. Personal Genome Service®(PGS)YouDot2021-05-19
0085946200627923andMe, Inc. Personal Genome Service®(PGS)YouDot2020-03-09
0085946200611823andMe, Inc. Personal Genome Service®(PGS)YouDotn/a2019-06-27
0085946200609523andMe, Inc. Personal Genome Service®(PGS)YouDotn/a2018-07-17
0086215000006023andMe, Inc. Personal Genome Service®YouDot (Carrier)2016-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860013485405Targeted Genomics, LLCGENOMECONSULT, LLCPTA2025-03-21
0085946200641523andMe, Inc. Personal Genome Service®(PGS)23ANDME GENOMICS LLCPKB2023-10-16
0085946200641523andMe, Inc. Personal Genome Service®(PGS)23ANDME GENOMICS LLCPTA2023-10-16
0085946200640823andMe, Inc. Personal Genome Service®(PGS)23ANDME GENOMICS LLCPKB2023-07-19
0085946200640823andMe, Inc. Personal Genome Service®(PGS)23ANDME GENOMICS LLCPTA2023-07-19
08437013457095A1AT Genotyping TestPROGENIKA BIOPHARMA, SAPTA2023-07-14
08437013457101A1AT Genotyping TestPROGENIKA BIOPHARMA, SAPTA2023-07-14
0085946200639223andMe, Inc. Personal Genome Service®(PGS)23ANDME GENOMICS LLCPKB2023-03-22
0085946200639223andMe, Inc. Personal Genome Service®(PGS)23ANDME GENOMICS LLCPTA2023-03-22
0085946200638523andMe, Inc. Personal Genome Service®(PGS)23ANDME GENOMICS LLCPKB2023-01-25
0085946200638523andMe, Inc. Personal Genome Service®(PGS)23ANDME GENOMICS LLCPTA2023-01-25
0085946200637823andMe, Inc. Personal Genome Service®(PGS)23ANDME GENOMICS LLCPKB2022-05-24
0085946200637823andMe, Inc. Personal Genome Service®(PGS)23ANDME GENOMICS LLCPTA2022-05-24
0085946200626223andMe, Inc. Personal Genome Service®(PGS)23ANDME GENOMICS LLCPKB2021-05-19
0085946200626223andMe, Inc. Personal Genome Service®(PGS)23ANDME GENOMICS LLCPTA2021-05-19
0085946200627923andMe, Inc. Personal Genome Service®(PGS)23ANDME GENOMICS LLCPKB2020-03-09
0085946200627923andMe, Inc. Personal Genome Service®(PGS)23ANDME GENOMICS LLCPTA2020-03-09
0085946200611823andMe, Inc. Personal Genome Service®(PGS)23ANDME GENOMICS LLCPKB2019-06-27
0085946200611823andMe, Inc. Personal Genome Service®(PGS)23ANDME GENOMICS LLCPTA2019-06-27
0085946200609523andMe, Inc. Personal Genome Service®(PGS)23ANDME GENOMICS LLCPKB2018-07-17
0085946200609523andMe, Inc. Personal Genome Service®(PGS)23ANDME GENOMICS LLCPTA2018-07-17
0086215000006023andMe, Inc. Personal Genome Service®23ANDME GENOMICS LLCPTA2016-09-21
0086215000006023andMe, Inc. Personal Genome Service®23ANDME GENOMICS LLCPKB2016-09-21