FDA Registration
Active
🇺🇸 United States
One Step Ecstasy Test
Reg #: 2025099
·
FEI: 3007981058
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Biomerica
- Registration Number
- 2025099
- FEI Number
- 3007981058
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 17571 Von Karman Ave
- City
- Irvine
- State
- CA
- ZIP
- 92614
- Country
- US
Regulatory Submissions
- 510(k) Number
- K022589
Owner / Operator
- Firm Name
- Biomerica, Inc.
- Operator Number
- 10023649
- Address
- 17571 Von Karman Ave
- City
- Irvine
- State
- CA
- Postal Code
- 92614
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Gas Chromatography, Methamphetamine | LAF | Class 2 | Clinical Toxicology | No | 2007-12-06 |
Proprietary Names
One Step Ecstasy Test
Establishment Types
Repack or Relabel Medical Device