Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3034246205

FEI Number

3034246205

Entity Name

BIOSQUARE Inc.

City/State/Country

Hwaseong-si Gyeonggi, KR

Establishment Address

15, Samsung 1-ro 4-gil, Hwaseong-si Gyeonggi 18449, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

BioSquare Inc. (Owner Number: 10092105)

Owner / Operator Contact Address

15, Samsung 1-ro 4-gil, Hwaseong-si, KR-41 18449, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

QuantumPACK Easy Strep A

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GTY	Antigens, All Groups, Streptococcus Spp.	Microbiology	Class 1	866.3740	2025-09-28

Official Correspondent

HOBEOM SONG

US Agent Details

Charles Mack Email: ircfda@gmail.com Phone: (931) 6254938

Related Public Records

Same Entity

BioSquare Inc.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K133343	Guangzhou Wondfo Biotech Co., Ltd.	WONDFO RAPID STREP A TEST	2014-01-31

Similar Registrations

Registration Number	Establishment Name	Location
2024674	QUIDEL CORP.	SAN DIEGO, CA, US
1649661	GERMAINE LABORATORIES, INC.	SAN ANTONIO, TX, US
9611882	SSI Diagnostica A/S	Hilleroed Hovedstaden, DK
3004635103	GUANGZHOU WONDFO BIOTECH CO., LTD.	Guangzhou Guangdong, CN
3017772438	Sekisui Diagnostics, LLC	San Diego, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3034246205. Last updated year: 2026. Please use registration number 3034246205 when referencing this establishment in official correspondence.