FDA Registration
Active
🇨🇦 Canada
Sekisui Diagnostics P.E.I. Inc.
Reg #: 8020316
·
FEI: 3002806809
·
Expires 2025
Products
4
Proprietary Names
0
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- Sekisui Diagnostics P.E.I. Inc.
- Registration Number
- 8020316
- FEI Number
- 3002806809
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 70 Watts Avenue
- City
- CHARLOTTETOWN Prince Edward Island
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K130255
Owner / Operator
- Firm Name
- Sekisui Diagnostics, LLC
- Operator Number
- 10035388
- Address
- 6659 Top Gun Street
- City
- San Diego
- State
- CA
- Postal Code
- 92121
- Country
- US
US Agent
- Business Name
- Sekisui Diagnostics, LLC
- Contact Name
- Jason Bilobram
- Address
- One Wall Street
- City
- Burlington
- State
- MA
- ZIP
- 01803
- Country
- US
- [email protected]
- Phone
- 781 6527848
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Hemoglobin A1c Test System | PDJ | Class 2 | Clinical Chemistry | No | 2014-04-02 |
| Assay, Glycosylated Hemoglobin | LCP | Class 2 | Hematology | No | 2014-04-02 |
| Calibrator, Secondary | JIT | Class 2 | Clinical Chemistry | No | 2014-04-02 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2014-04-02 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)