FDA Registration Active 🇲🇽 Mexico

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

Reg #: 3004569406 · FEI: 3004569406 · Expires 2026
Products
10
Proprietary Names
12
Establishment Types
1
Classifications
10

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Registration Details

Registration Name
BIOMERICA DE MEXICO, S.A. DE C.V.
Registration Number
3004569406
FEI Number
3004569406
Status
Active
Expiry Year
2026
Initial Importer
No
Address
SATURNO 20-A, PARQUE INDUSTRIAL MEXICALI 1
City
MEXICALI Baja California
Country
MX

Regulatory Submissions

510(k) Number
K991469

Owner / Operator

Firm Name
Biomerica, Inc.
Operator Number
2016793
Address
17571 Von Karman Ave, --
City
Irvine
State
CA
Postal Code
92614
Country
US

US Agent

Business Name
BIOMERICA, INC.
Contact Name
Bonnie Qiu
Address
17571 Von Karman Ave
City
Irvine
State
CA
ZIP
92614
Country
US
Phone
949 6452111 ext. 878

Products

Device Name Product Code
Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.) JIQ
Antisera, All Types, Listeria Monocytogenes GSH
System, Imaging, Pulsed Echo, Ultrasonic IYO
Reagent, Occult Blood KHE
Antigen, C. Difficile MCB
Antisera, All Groups, Salmonella Spp. GRM
Radioimmunoassay, Luteinizing Hormone CEP
Visual, Pregnancy Hcg, Prescription Use JHI
Giardia Spp. MHI
Antisera, All Types, Shigella Spp. GNB

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 Shigella Lateral Flow Rapid Test

Establishment Types

Manufacture Medical Device