Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017550662

FEI Number

3017550662

Entity Name

MAQ-OPS, S. DE R.L.

City/State/Country

Tijuana Baja California, MX

Establishment Address

Calle Guerrero Negro 9942, Parque Industrial Pacifico IV, Tijuana Baja California C.P. 22644, MX

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ACON Laboratories, Inc. (Owner Number: 9063887)

Owner / Operator Contact Address

5850 Oberlin Drive, #340, San Diego, CA 92121, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K230828

PMA Number

N/A

All Registered Proprietary Names

Flowflex® Plus Strep A Rapid Test Strip Flowflex® Plus Strep A Rapid Test Cassette Flowflex Plus COVID-19 + Flu A/B Home Test Flowflex COVID-19 Antigen Home Test

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	2025-12-02
SCA	Multi-Analyte Respiratory Virus Antigen Detection Test	Microbiology	Class 2	866.3987	2025-08-20
QMN	Covid-19 Multi-Analyte Antigen Device	Unknown	Class N	N/A	2024-07-23
QYT	Over-The-Counter Covid-19 Antigen Test	Microbiology	Class 2	866.3984	2024-01-02

Official Correspondent

Catherine Shi

US Agent Details

Catherine Shi Business: ACON LABORATORIES INC. Email: cshi@aconlabs.com Phone: (858) 8758068

Related Public Records

Same Entity

ACON Laboratories, Inc.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
2531491	ACON LABORATORIES, INC.	SAN DIEGO, CA, US

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
K241317	Guangzhou Wondfo Biotech Co., Ltd.	Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)	2024-09-30

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 3017550662. Last updated year: 2026. Please use registration number 3017550662 when referencing this establishment in official correspondence.