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
- [email protected]
- Phone
- 949 6452111 ext. 878
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.) | JIQ | Class 1 | Clinical Chemistry | No | 2018-11-01 |
| Antisera, All Types, Listeria Monocytogenes | GSH | Class 1 | Microbiology | No | 2016-11-07 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2009-03-02 |
| Reagent, Occult Blood | KHE | Class 2 | Hematology | No | 2001-01-16 |
| Antigen, C. Difficile | MCB | Class 1 | Microbiology | No | 2016-11-07 |
| Antisera, All Groups, Salmonella Spp. | GRM | Class 2 | Microbiology | No | 2016-11-07 |
| Radioimmunoassay, Luteinizing Hormone | CEP | Class 1 | Clinical Chemistry | No | 1985-11-22 |
| Visual, Pregnancy Hcg, Prescription Use | JHI | Class 2 | Clinical Chemistry | No | 2009-03-05 |
| Giardia Spp. | MHI | Class 2 | Microbiology | No | 2016-11-07 |
| Antisera, All Types, Shigella Spp. | GNB | Class 2 | Microbiology | No | 2016-11-07 |
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