Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011781554

FEI Number

3011781554

Entity Name

GENETIC SIGNATURES LIMITED

City/State/Country

Newtown New South Wales, AU

Establishment Address

7 Eliza St, Newtown New South Wales 2042, AU

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Genetic Signatures Limited (Owner Number: 10049463)

Owner / Operator Contact Address

7 Eliza St, Newtown, Sydney, AU-NSW 2042, AU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

3base ASRs

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MVU	Reagents, Specific, Analyte	Pathology	Class 1	864.4020	2017-08-28

Official Correspondent

No official correspondent registered.

US Agent Details

Mike Aicher Business: Genetic Signatures US Ltd Email: maicher@geneticsignatures.com Phone: (310) 3867863

Related Public Records

Same Entity

Genetic Signatures Limited

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011781554. Last updated year: 2026. Please use registration number 3011781554 when referencing this establishment in official correspondence.