Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004569406

FEI Number

3004569406

Entity Name

BIOMERICA DE MEXICO, S.A. DE C.V.

City/State/Country

MEXICALI Baja California, MX

Establishment Address

SATURNO 20-A, PARQUE INDUSTRIAL MEXICALI 1, MEXICALI Baja California 21210, MX

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Biomerica, Inc. (Owner Number: 2016793)

Owner / Operator Contact Address

17571 Von Karman Ave, --, Irvine, CA 92614, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Microalbumin Fortel Microalbumin Screening Listeria Lateral Flow Rapid Test Aware Breast Pad MODIFIED EZ DETECT OCC C. difficile (GDH) Salmonella Lateral Flow Rapid Test LH Lateral Flow Rapid Test FORTEL OVULATION EZ HCG Giardia Lateral Flow Rapid Test

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JIQ	Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2018-11-01
GSH	Antisera, All Types, Listeria Monocytogenes	Microbiology	Class 1	866.3355	2016-11-07
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2009-03-02
KHE	Reagent, Occult Blood	Hematology	Class 2	864.6550	2001-01-16
MCB	Antigen, C. Difficile	Microbiology	Class 1	866.2660	2016-11-07
GRM	Antisera, All Groups, Salmonella Spp.	Microbiology	Class 2	866.3550	2016-11-07
CEP	Radioimmunoassay, Luteinizing Hormone	Clinical Chemistry	Class 1	862.1485	1985-11-22
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2009-03-05
MHI	Giardia Spp.	Microbiology	Class 2	866.3220	2016-11-07

Official Correspondent

No official correspondent registered.

US Agent Details

Bonnie Qiu Business: BIOMERICA, INC. Email: bqiu@biomerica.com Phone: (949) 6452111

Related Public Records

Same Entity

Biomerica, 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
2025099	Biomerica	Irvine, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K882805	Coopervision-Cilco	CILCO VILLASENOR PACHYMETER	1988-08-12
K791040	Shimadzu Corp.	SECTOR SCANNER, SDU-100, COMPUTERIZED	1979-10-04
K162372	Qt Ultrasound, LLC	QT Ultrasound Breast Scanner-1	2017-06-06
K930964	Acuson Corp.	ACUSON MODEL #29001 (DIAGNOSTIC ULTRASOUND DEVICE)	1994-10-26
K052355	U-Systems, Inc.	AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS	2005-09-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-2011	Verathon, Inc.	2	BVI 9600 Bladder Volume Instrument, Aorta Scan Mode The BladderScan BVI 9600 with AortaScan Mode is a user-selectable, dual-function ultrasound device that projects ultrasound energy either into the lower abdomen to obtain an image of the bladder for measuring bladder volume, or into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements.
Z-0004-2011	Verathon, Inc.	2	AortaScan AMI 9700 The AortaScan AMI 9700 is an ultrasound device that projects ultrasound energy into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements
Z-0005-2011	Verathon, Inc.	2	BladderScan BVM 9500 The BladderScan BVM 9500 is intended to project ultrasound energy through the lower abdomen to obtain an image of the bladder and measure urinary bladder volume and mass noninvasively.
Z-0027-2014	SonoSite, Inc.	2	P21x/5-1 MHz transducer, Part Number P07698-23 Product Usage: The P21x/5-1 MHz phased array transducer is designed for cardiac, abdominal and obstetric, TCD and orbital exams. It supports 2D with SonoMB Multi Beam Technology and Auto Gain capabilities, SonoHD Imaging Technology, Tissue Harmonic Imaging, M-Mode, Velocity Color Flow Doppler, Color Power Doppler (CDP), Pulsed Wave (PW), TDI Pulsed Wave, and Continuous Wave Doppler.
Z-0006-05	Abbott Health Products, Inc.	2	AxSYM Total B-hCG Reagent, Product list number: 7A59-22 and 7A59-21

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004569406. Last updated year: 2026. Please use registration number 3004569406 when referencing this establishment in official correspondence.