FDA Registration
Active
🇺🇸 United States
iCassetteTM Urine Test Drug Screen Cassette
Reg #: 2027969
·
FEI: 1000125596
·
Expires 2025
Products
1
Proprietary Names
5
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Alere San Diego, Inc.
- Registration Number
- 2027969
- FEI Number
- 1000125596
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 9942 Mesa Rim Road
- City
- SAN DIEGO
- State
- CA
- ZIP
- 92121
- 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 System, Nicotine, Cotinine, Metabolites | MRS | Class 1 | Clinical Toxicology | No | 2012-03-05 |
Proprietary Names
iCassetteTM Urine Test Drug Screen Cassette
iScreenTM Oral Fluid Test Drug Screen Pad
SureStep Urine Test Drug Screen Cassette, Cotinine (COT 200)
JANT Pharmacal Accutest COT One Step Cotinine Test Device in Urine
COT One Step Cotinine Urine Test Device in Urine
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility