Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3034617817

FEI Number

3034617817

Entity Name

Siro Diagnostics, Inc.

City/State/Country

San Diego, CA, US

Establishment Address

9877 Waples Street, San Diego, CA 92121, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Siro Diagnostics, Inc. (Owner Number: 10092299)

Owner / Operator Contact Address

9877 Waples Street, San Diego, CA 92121, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

DEN220028

PMA Number

N/A

All Registered Proprietary Names

Siro Diagnostics COVID-19 Molecular Test

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QWB	Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens	Microbiology	Class 2	866.3984	2024-12-20

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Siro Diagnostics, Inc.

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 3034617817. Last updated year: 2026. Please use registration number 3034617817 when referencing this establishment in official correspondence.