Biomerica, Inc.

SRN US-MF-000015772

manufacturer · Irvine, CA, US · 27 devices

17571 Von Karman Avenue, 92614

Devices

Name	UDI-DI	Class	Badge
ACTH (Adrenocorticotropic Hormone) ELISA	00083059070231	Unknown class	No Certificate Found Snapshot 2026-10-25 · Link to EUDAMED
Allerquant™ 14G A ELISA	00083059071948	Unknown class	No Certificate Found Snapshot 2026-10-25 · Link to EUDAMED
Allerquant™ 14G B ELISA	00083059071825	Unknown class	No Certificate Found Snapshot 2026-10-25 · Link to EUDAMED
Allerquant™ 42G A ELISA	00083059071795	Unknown class	No Certificate Found Snapshot 2026-10-25 · Link to EUDAMED
Allerquant™ 4G A ELISA	00083059071870	Unknown class	No Certificate Found Snapshot 2026-10-25 · Link to EUDAMED
Allerquant™ 4G B ELISA	00083059071849	Unknown class	No Certificate Found Snapshot 2026-10-25 · Link to EUDAMED
Allerquant™ 7G A ELISA	00083059071894	Unknown class	No Certificate Found Snapshot 2026-10-25 · Link to EUDAMED
Allerquant™ 90G ELISA	00083059071917	Unknown class	No Certificate Found Snapshot 2026-10-25 · Link to EUDAMED
Aware Breast Self Exam	00083059012033	Class I	No Certificate Found Snapshot 2026-10-25 · Link to EUDAMED
Calcitonin ELISA	00083059070248	Unknown class	No Certificate Found Snapshot 2026-10-25 · Link to EUDAMED
EPO (Erythropoietin) ELISA	00083059070255	Unknown class	No Certificate Found Snapshot 2026-10-25 · Link to EUDAMED
EZ Detect Colon Disease Test	00083059100013	Unknown class	No Certificate Found Snapshot 2026-10-25 · Link to EUDAMED
EZ Detect™ Fecal Occult Blood Test Professional	00083059010015	Unknown class	No Certificate Found Snapshot 2026-10-25 · Link to EUDAMED
EZ Detect™ Home Test for Hidden Blood in The Stool	00083059010008	Unknown class	No Certificate Found Snapshot 2026-10-25 · Link to EUDAMED
Fortel® Kidney Disease (Microalbumin) Screening Test	00083059140019	Unknown class	No Certificate Found Snapshot 2026-10-25 · Link to EUDAMED
Fortel® Prostate (PSA) Screening Test	00083059108118	Unknown class	No Certificate Found Snapshot 2026-10-25 · Link to EUDAMED
Fortel Ultra Sensitive Pregnancy Midstream 1-Test	00083059114713	Unknown class	No Certificate Found Snapshot 2026-10-25 · Link to EUDAMED
Fortel Ultra Sensitive Pregnancy Midstream 2-Test	00083059114720	Unknown class	No Certificate Found Snapshot 2026-10-25 · Link to EUDAMED
GAP IgM Helicobacter pylori ELISA	00083059070064	Unknown class	No Certificate Found Snapshot 2026-10-25 · Link to EUDAMED
Hp Detect™ Stool Antigen ELISA	00083059070835	Unknown class	No Certificate Found Snapshot 2026-10-25 · Link to EUDAMED
Intact PTH (Parathyroid Hormone) ELISA	00083059070224	Unknown class	No Certificate Found Snapshot 2026-10-25 · Link to EUDAMED
Isletest™ GAD ELISA	00083059070095	Unknown class	No Certificate Found Snapshot 2026-10-25 · Link to EUDAMED
Isletest™ IAA ELISA	00083059070118	Unknown class	No Certificate Found Snapshot 2026-10-25 · Link to EUDAMED
Isletest™ ICA ELISA	00083059070101	Unknown class	No Certificate Found Snapshot 2026-10-25 · Link to EUDAMED
NutriDetect™ 7G B IgG ELISA	00083059071818	Class B	No Certificate Found Snapshot 2026-10-25 · Link to EUDAMED