FDA Registration
Active
🇺🇸 United States
SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay 100 mL Kit
Reg #: 2020952
·
FEI: 2020952
·
Expires 2025
Products
1
Proprietary Names
5
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Alere San Diego Inc.
- Registration Number
- 2020952
- FEI Number
- 2020952
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 829 Towne Center Drive
- City
- Pomona
- State
- CA
- ZIP
- 91767
- Country
- US
Owner / Operator
- Firm Name
- Abbott
- Operator Number
- 9006731
- Address
- 100 Abbott Park Road, Dept. RX51/J55/MS 6134
- City
- Abbott Park
- State
- IL
- Postal Code
- 60064
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Test, Methamphetamine, Employment And Insurance Testing, Exempt | PVD | Class 2 | Clinical Toxicology | No | 2020-03-03 |
Proprietary Names
SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay 100 mL Kit
SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay 500 mL Kit
SEFRIA Ecstasy Oral Fluid Enzyme Immunoassay 500 mL kit
SEFRIA Ecstasy Oral Fluid Enzyme Immunoassay 100 mL kit
eCup+ Drug Screening Device (REF 94615)
Establishment Types
Manufacture Medical Device