FDA Registration
Active
🇺🇸 United States
OPTIGEN US Food 20
Reg #: 2936856
·
FEI: 2936856
·
Expires 2025
Products
1
Proprietary Names
9
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Canon Medical Diagnostics USA, Inc.
- Registration Number
- 2936856
- FEI Number
- 2936856
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 630 Clyde Ct
- City
- MOUNTAIN VIEW
- State
- CA
- ZIP
- 94043
- Country
- US
Owner / Operator
- Firm Name
- Canon Medical Diagnostics USA, Inc.
- Operator Number
- 2936856
- Address
- 630 CLYDE CT., --
- City
- Mountain View
- State
- CA
- Postal Code
- 94043
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Test, Radioallergosorbent (Rast) Immunological, Exempt Allergens | PUW | Class 2 | Immunology | No | 2017-12-06 |
Proprietary Names
OPTIGEN US Food 20
OPTIGEN US Panel Control Reagent Kit
OPTIGEN US Mix 36
OPTIGEN US Inhalant 36
OPTIGEN US Food 25
OPTIGEN Environmental 36 (20T)
OPTIGEN US Food 30 (100 ND)
OPTIGEN US Environmental 36 (100ND)
OPTIGEN Food 29 (20T)
Establishment Types
Manufacture Medical Device