Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016820006

FEI Number

3016820006

Entity Name

SALOFA OY

City/State/Country

Salo Varsinais-Suomi, FI

Establishment Address

Satamakatu 16, Salo Varsinais-Suomi 24100, FI

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Salofa Oy (Owner Number: 10071162)

Owner / Operator Contact Address

Satamakatu 16, Salo, FI-19 24100, FI

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Sienna COVID-19 Antigen Rapid Test Cassette Clarity COVID-19 Antigen Rapid Test Cassette Salocor COVID-19 Antigen Rapid Test Cassette Sienna COVID-19 IgG/IgM Rapid Test Cassette Clarity COVIBLOCK COVID-19 IgG/IgM Antibody Test

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QKP	Coronavirus Antigen Detection Test System.	Unknown	Class N	N/A	2021-02-03
QKO	Reagent, Coronavirus Serological	Unknown	Class N	N/A	2020-04-24

Official Correspondent

Christoffer Riska

US Agent Details

Kwan Tse Business: Seroclinix Corporation Email: ktse@seroclinix.com Phone: (716) 2629808

Related Public Records

Same Entity

Salofa Oy

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2023	Jiangsu Well Biotech Co., Ltd. No	N	Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02

Similar Registrations

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3043128348	Shenzhen Yang Biotech Co., Ltd.	Shenzhen Guangdong, CN
9610126	ROCHE DIAGNOSTICS GMBH	MANNHEIM Baden-Wurttemberg, DE
3008054239	CORE TECHNOLOGY CO., LTD.	Changping District Beijing, CN
3016761091	Shenzhen Watmind Medical Co., Ltd.	Shenzhen Guangdong, CN
3002642396	Ortho Clinical Diagnostics	Singapore South West, SG

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016820006. Last updated year: 2026. Please use registration number 3016820006 when referencing this establishment in official correspondence.