TWIST BIOSCIENCE CORPORATION

FDA Device Registration & Listing · South San Francisco, CA, US · Registration 3015547437

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3015547437
FEI Number
3015547437
Entity Name
TWIST BIOSCIENCE CORPORATION
City/State/Country
South San Francisco, CA, US
Establishment Address
681 Gateway Boulevard, South San Francisco, CA 94080, US
Establishment Type(s)
Manufacture Device in the United States for Export Only
Owner / Operator
Twist Bioscience Corporation (Owner Number: 10077255)
Owner / Operator Contact Address
681 Gateway Boulevard, South San Francisco, CA 94080, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Twist Precision Exome Dx Panel Twist Precision Prep and Enrichment Dx Kit Twist Precision Exome Dx Kit

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PFT Reagents For Molecular Diagnostic Test Systems Clinical Chemistry Class 1 862.3800 2025-02-06

Official Correspondent

Mark Buck

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Twist Bioscience Corporation
View consolidated registration, premarket clearance, and recall records for this applicant.
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015547437. Last updated year: 2026. Please use registration number 3015547437 when referencing this establishment in official correspondence.
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