FDA Registration
Active
🇺🇸 United States
Surestep AMP Test
Reg #: 2951296
·
FEI: 1000221312
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- INTERNATIONAL IMMUNO DIAGNOSTICS
- Registration Number
- 2951296
- FEI Number
- 1000221312
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1155 Chess Dr 121
- City
- FOSTER CITY
- State
- CA
- ZIP
- 94404
- Country
- US
Regulatory Submissions
- 510(k) Number
- K994395
Owner / Operator
- Firm Name
- International Immuno Diagnostics
- Operator Number
- 9008016
- Address
- 1291 E Hillsdale Blvd #221, --
- City
- Foster City
- State
- CA
- Postal Code
- 94404
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Enzyme Immunoassay, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2024-08-01 |
Proprietary Names
Surestep AMP Test
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility