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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
- —
- —
- [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 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| ACTH (Adrenocorticotropic Hormone) ELISA | 7023 | EUDAMEDFDA UDI | IVD General | Active |
| Fortel® Kidney Disease (Microalbumin) Screening Test | 1400-1 | EUDAMED | IVD devices for self-testing | Active |
| GAP IgM Helicobacter pylori ELISA | 7006 | EUDAMED | IVD General | Active |
| EZ Detect™ Home Test for Hidden Blood in The Stool | 1000 | EUDAMED | IVD devices for self-testing | Active |
| Fortel® Prostate (PSA) Screening Test | 1081-1 | EUDAMED | IVD Annex II List B | Active |
| Allerquant™ 4G B ELISA | 7184 | EUDAMED | IVD General | Active |
| Allerquant™ 42G A ELISA | 7179 | EUDAMED | IVD General | Active |
| EZ Detect™ Fecal Occult Blood Test Professional | 1001 | EUDAMEDFDA UDI | IVD devices for self-testing | Active |
| Isletest™ IAA ELISA | 7011 | EUDAMED | IVD General | Active |
| NutriDetect™ 90G M IgG ELISA | 7191 | EUDAMED | Class B | Active |
| Allerquant™ 90G ELISA | 7193 | EUDAMED | IVD General | Active |
| Calcitonin ELISA | 7024 | EUDAMEDFDA UDI | IVD General | Active |
| EPO (Erythropoietin) ELISA | 7025 | EUDAMEDFDA UDI | IVD General | Active |
| NutriDetect™ 7G B IgG ELISA | 7181 | EUDAMED | Class B | Active |
| EZ-PSA Professional PSA Test | 1081-15 | EUDAMED | IVD Annex II List B | Active |
| Allerquant™ 14G A ELISA | 7194 | EUDAMED | IVD General | Active |
| NutriDetect™ 14G B ELISA | 7182 | EUDAMED | Class B | Active |
| NutriDetect™ 90G B IgG ELISA | 7180 | EUDAMED | Class B | Active |
| Intact PTH (Parathyroid Hormone) ELISA | 7022 | EUDAMEDFDA UDI | IVD General | Active |
| Fortel Ultra Sensitive Pregnancy Midstream 1-Test | 1147-01 | EUDAMED | IVD devices for self-testing | Active |
Related Companies
Authorised Representatives
- MDSS GmbH DE
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
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. |