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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Autosomal recessive carrier screening gene mutation detection system
Classification Name: AUTOSOMAL RECESSIVE CARRIER SCREENING GENE MUTATION DETECTION SYSTEM
Product Code: PKB
Device Class: 2
Regulation Number: 866.5940
Medical Specialty: Immunology
Registered Establishment Name: 23andMe Genomics LLC
Registered Establishment Number: 3007699459
Premarket Submission Number: DEN140044
Owner/Operator: 23andMe Genomics LLC
Owner/Operator Number: 10029404
Establishment Operations: Manufacturer
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