FDA Registration
Active
🇺🇸 United States
Lyme Disease
Reg #: 3031090645
·
FEI: 3031090645
·
Expires 2025
Products
1
Proprietary Names
6
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- IXLAYER
- Registration Number
- 3031090645
- FEI Number
- 3031090645
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 447 Sutter Street, Suite 405, PMB 53
- City
- San Francisco
- State
- CA
- ZIP
- 94108
- Country
- US
Owner / Operator
- Firm Name
- ixlayer
- Operator Number
- 10090689
- Address
- 447 Sutter Street, Suite 405, PMB 53
- City
- San Francisco
- State
- CA
- Postal Code
- 94108
- Country
- US
- Correspondent
- Shivanie Plaza
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Blood Specimen Collection Convenience Kit (Excludes Hiv) | PQD | Class 2 | Clinical Chemistry | No | 2024-04-29 |
Proprietary Names
Lyme Disease
Type 1 Diabetes Autoantibody Screening
Eosinophilic Asthma Screening
Cholesterol
Vitamin D
Celiac Assessment
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility