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BIOMERICA, INC.

United States·US-MF-000015772

Last updated May 27, 2026

What BIOMERICA, INC. makes

Biomérica manufactures in vitro diagnostic (IVD) test kits for detecting specific pathogens and biomarkers, including enzyme immunoassays (EIA) for *Giardia lamblia*, *Cryptosporidium*, *Entamoeba histolytica*, and *Helicobacter pylori* antibodies. Rapid immunochromatographic tests (ICT) are also produced for *Salmonella*, *Shigella* toxins, and *beta-hCG* in pregnancy testing, alongside spectrophotometric assays for C-reactive protein (CRP). Additional products include enzyme-linked immunosorbent assays (ELISA) for cardiac markers like troponin I and myoglobin, as well as self-testing devices such as a breast self-exam pad.

The company’s diagnostic portfolio spans Class I, Class II, and Class B medical devices, with several listed under IVD Annex II List B and IVD General categories, including self-testing devices. These products are registered in eudamed, with regulatory submissions documented in the FDA’s 510(k) and UDI databases. The manufacturer is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: United States
Address: 17571, Von Karman Avenue, Irvine, CA, United States
Website: www.biomerica.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1 949 645 2111
PRRC Contact: Bonnie Qiu
EUDAMED SRN: US-MF-000015772
FDA FEI Number: —
DUNS Number: 067647321

Catalogue (70)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
Giardia ELISA [Enzyme-Linked ImmunoSorbent Assay]	7069	FDA UDI	Class II	Active
Giardia ELISA [Enzyme-Linked ImmunoSorbent Assay]	7069	FDA UDI	Class II	Unknown
Troponin I (human Cardiac-Specific) Enzyme Immunoassay Test Kit	7031	FDA UDI	Class II	Active
EZ Detect Colon Disease Test	1000-1	FDA UDI	Class II	Unknown
E. histolytica ELISA [Enzyme-Linked ImmunoSorbent Assay]	7078	FDA UDI	Class II	Unknown
EZ-SALMONELLA One-Step Salmonella species Rapid Test	1007-15	FDA UDI	Class II	Active
ACTH [Adrenocorticotropic Hormone] ELISA	7023	FDA UDI	Class II	Unknown
EPO [Erythropoietin] ELISA [Enzyme-Linked ImmunoSorbent Assay]	7025	FDA UDI	Class II	Unknown
EZ-GIARDIA One-Step Giardia Test	1501-15	FDA UDI	Class II	Active
Aware Breast Self-Exam Pad	1207	FDA UDI	Class II	Active
Calcitonin ELISA [Enzyme-Linked ImmunoSorbent Assay]	7024	FDA UDI	Class II	Unknown
EZ-SALMONELLA One-Step Salmonella species Rapid Test	1007-15	FDA UDI	Class II	Unknown
EZ-hCG Urine Pregnancy Test	1048-25	FDA UDI	Class II	Unknown
GAP®-IgG (Gastritis and Peptic Ulcer Test)	7004	FDA UDI	Class I	Active
Cryptosporidium ELISA [Enzyme-Linked ImmunoSorbent Assay]	7063	FDA UDI	Class II	Unknown
Cryptosporidium ELISA [Enzyme-Linked ImmunoSorbent Assay]	7063	FDA UDI	Class II	Active
EZ-SHIGELLA One-Step Shigella species Rapid Test	1009-15	FDA UDI	Class II	Unknown
EZ-GIARDIA One-Step Giardia Test	1501-15	FDA UDI	Class II	Unknown
High Sensitivity C-Reactive Protein Enzyme Immunoassay Test Kit	7033	FDA UDI	Class II	Unknown
EZ-hCG Urine Pregnancy Test	1048-25	FDA UDI	Class II	Active
GAP®-IgG (Gastritis and Peptic Ulcer Test)	7004	FDA UDI	Class I	Unknown
EZ-SHIGELLA One-Step Shigella species Rapid Test	1009-15	FDA UDI	Class II	Active
High Sensitivity C-Reactive Protein Enzyme Immunoassay Test Kit	7033	FDA UDI	Class II	Active
Aware Breast Self-Exam Pad	1203	FDA UDI	Class II	Active
Intact-PTH [Parathyroid Hormone] ELISA [Enzyme-Linked ImmunoSorbent Assay]	7022	FDA UDI	Class II	Active
Troponin I (human Cardiac-Specific) Enzyme Immunoassay Test Kit	7031	FDA UDI	Class II	Unknown
EZ Detect Fecal Occult Blood Test	1001	FDA UDI	Class II	Unknown
E. histolytica ELISA [Enzyme-Linked ImmunoSorbent Assay]	7078	FDA UDI	Class II	Active
Myoglobin Enzyme Immunoassay Test Kit	7030	FDA UDI	Class II	Unknown
Myoglobin Enzyme Immunoassay Test Kit	7030	FDA UDI	Class II	Active
Isletest™ GAD ELISA	7009	EUDAMED	IVD General	Active
Isletest™ ICA ELISA	7010	EUDAMED	IVD General	Active
Fortel Ovulation Prediction Test	1251	EUDAMED	IVD devices for self-testing	Active
Fortel® Ulcer (H. pylori) Screening Test	1005-1	EUDAMED	IVD devices for self-testing	Active
Free T4 Microwell Eia, Model #7019	K982954	FDA 510(k)	Class II	Active
Gap Igg H.pylori Modified	K915185	FDA 510(k)	Class I	Active
Tsh (microwell) Elisa	K962216	FDA 510(k)	Class II	Active
T-3 Microwell Eia Model 7013	K960412	FDA 510(k)	Class II	Active
Hp Detect™ Stool Antigen ELISA	K232892	FDA 510(k)	Class I	Active
Thyroglobulin Autoantibody Enzyme Immunoassay	K936010	FDA 510(k)	Class II	Active
Gap-Igg	K900343	FDA 510(k)	Class I	Active
T4 Microwell Eia (enzyme Immunoassay0	K950588	FDA 510(k)	Class II	Active
Anti-Tpo	K954256	FDA 510(k)	Class II	Active
Ez-Hcg Urine(pregnancy Test)	K003856	FDA 510(k)	Class II	Active
Fortel Ultra Sensitive Pregnancy Midstream 2-Test	1147-02	EUDAMED	IVD devices for self-testing	Active
EZ Detect Colon Disease Test	1000-1	EUDAMEDFDA UDI	IVD devices for self-testing	Active
Allerquant™ 4G A ELISA	7187	EUDAMED	IVD General	Active
Hp Detect™ Stool Antigen ELISA	7083	EUDAMEDFDA UDI	IVD General	Active
Aware Breast Self Exam	1203	EUDAMEDFDA UDI	Class I	Active
NutriDetect™ 7G A ELISA	7189	EUDAMED	Class B	Active

Related Companies

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MDSS GmbH DE

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FDA Recalls (1)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Biomérica, Inc. has one FDA recall record initiated on September 18, 2014, which is recorded as terminated. The reason stated in the filing was a potential issue with false high values.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Sep 18, 2014	Z-0467-2015	—	terminated	A potential issue with false high values.