FDA Registration
Active
🇺🇸 United States
MarScreen® IgA, IgG, IgM
Reg #: 2025606
·
FEI: 2025606
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- CalibreScientific US, Inc.
- Registration Number
- 2025606
- FEI Number
- 2025606
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1311 Se Cardinal Ct Ste 170
- City
- VANCOUVER
- State
- WA
- ZIP
- 98683
- Country
- US
Owner / Operator
- Firm Name
- CalibreScientific US, Inc.
- Operator Number
- 2025606
- Address
- 1311 SE Cardinal Ct, #170
- City
- Vancouver
- State
- WA
- Postal Code
- 98683
- Country
- US
- Correspondent
- Jigar Patel
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Sperm, Antigen, Antiserum, Control | DFQ | Class 1 | Immunology | No | 2024-06-03 |
Proprietary Names
MarScreen® IgA, IgG, IgM
ImmunoSpheres®Anti-IgA, Anti-IgG, Anti-IgM, Anti-Ig(H&L)
Sperm Antibody A/G Serum Controls
Establishment Types
Manufacture Medical Device