Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2025099

FEI Number

3007981058

Entity Name

Biomerica

City/State/Country

Irvine, CA, US

Establishment Address

17571 Von Karman Ave, Irvine, CA 92614, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Biomerica, Inc. (Owner Number: 10023649)

Owner / Operator Contact Address

17571 Von Karman Ave, Irvine, CA 92614, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K232892

PMA Number

N/A

All Registered Proprietary Names

Myoglobin ELISA COVID-19 Antigen Rapid Test (Oral Fluid) COVID-19 Antigen Rapid Test (Nasopharyngeal Swab) Aware Pad (Breast Self-Exam) Fortel Ulcer (H. pylori) Screening Test One Step Amphetamine Test Fortel Kidney Disease (Microalbumin) Screening Test One Step Cocaine Test hs C-Reactive Protein ELISA COVID-19 IgG/IgM Rapid Test One Step Ecstasy Test EZ-LH One Step Buprenorphine Test Human Cardiac Troponin I ELISA Fortel Kidney Disease (Microalbumin) Screening Test Calcitonin ELISA ACTH ELISA Kit One Step Tricyclic Antidepressants One Step Methadone Test One Step Benzodiazepines Test GAP IgG ELISA Hp Detect Stool Antigen ELISA

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DRR	Amplifier And Signal Conditioner, Biopotential	Cardiovascular	Class 2	870.2050	2007-12-06
QKP	Coronavirus Antigen Detection Test System.	Unknown	Class N	N/A	2020-12-21
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2007-12-06
LYR	Helicobacter Pylori	Microbiology	Class 1	866.3110	2007-12-06
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2007-12-06
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2024-10-17
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2007-12-06
DCK	C-Reactive Protein, Antigen, Antiserum, And Control	Immunology	Class 2	866.5270	2007-12-06
QKO	Reagent, Coronavirus Serological	Unknown	Class N	N/A	2020-03-26
LAF	Gas Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2007-12-06
CEP	Radioimmunoassay, Luteinizing Hormone	Clinical Chemistry	Class 1	862.1485	2007-12-06
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2007-12-06
MMI	Immunoassay Method, Troponin Subunit	Clinical Chemistry	Class 2	862.1215	2007-12-06
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2012-02-09
JKR	Radioimmunoassay, Calcitonin	Clinical Chemistry	Class 2	862.1140	2007-12-06
CKG	Radioimmunoassay, Acth	Clinical Chemistry	Class 2	862.1025	2007-12-06
LFG	Radioimmunoassay, Tricyclic Antidepressant Drugs	Clinical Toxicology	Class 2	862.3910	2007-12-06
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2007-12-06
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2007-12-06
LYR	Helicobacter Pylori	Microbiology	Class 1	866.3110	2007-12-06
LYR	Helicobacter Pylori	Microbiology	Class 1	866.3110	2024-01-04

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

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
3004569406	BIOMERICA DE MEXICO, S.A. DE C.V.	MEXICALI Baja California, MX

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-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
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.

Similar Registrations

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2025099. Last updated year: 2026. Please use registration number 2025099 when referencing this establishment in official correspondence.