Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010890428

FEI Number

3010890428

Entity Name

SIENNA CANCER DIAGNOSTICS LIMITED

City/State/Country

Melbourne Victoria, AU

Establishment Address

23 Normanby Road, Notting Hill, Melbourne Victoria 3168, AU

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Sienna Cancer Diagnostics Limited (Owner Number: 10046528)

Owner / Operator Contact Address

23 Normanby Road, Notting Hill, Melbourne, AU-VIC 3168, AU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Anti-hTERT antibody (SCD-A7) Anti-hTERT Antibody (SCD-A7)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MVU	Reagents, Specific, Analyte	Pathology	Class 1	864.4020	2014-04-02
NJT	Immunohistochemistry Reagents And Kits	Hematology	Class 1	864.1860	2016-11-02

Official Correspondent

Emma Ball

US Agent Details

Marissa Vilchez Email: m.vilchez@mdssar.com Phone: (312) 9751694

Related Public Records

Same Entity

Sienna Cancer Diagnostics Limited

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3012104694	EUROFINS GENOMICS LLC	Louisville, KY, US
1124976	SUPERTECHS, INC.	Gaithersburg, MD, US
3011873748	AUGUREX LIFE SCIENCES CORP	Vancouver British Columbia, CA
3013059683	ATSI Logistics Center ApS	GLOSTRUP Hovedstaden, DK
3004375571	GLYCOMINDS DIAGNOSTICS (2014) LTD.	Raanana Central, IL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010890428. Last updated year: 2026. Please use registration number 3010890428 when referencing this establishment in official correspondence.