FDA Registration
Active
🇺🇸 United States
Quidel Triage(R) MeterPro
Reg #: 3013982035
·
FEI: 3013982035
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- Quidel Cardiovascular Inc.
- Registration Number
- 3013982035
- FEI Number
- 3013982035
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 9975 Summers Ridge Road, --
- City
- San Diego
- State
- CA
- ZIP
- 92121
- Country
- US
Regulatory Submissions
- 510(k) Number
- K973547
Owner / Operator
- Firm Name
- QuidelOrtho Corp.
- Operator Number
- 2024674
- Address
- 9975 Summers Ridge Road, --
- City
- San Diego
- State
- CA
- Postal Code
- 92121
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Immunoassay Method, Troponin Subunit | MMI | Class 2 | Clinical Chemistry | No | 2017-10-17 |
| Myoglobin, Antigen, Antiserum, Control | DDR | Class 2 | Immunology | No | 2017-10-17 |
| Fluorometric Method, Cpk Or Isoenzymes | JHX | Class 2 | Clinical Chemistry | No | 2017-10-17 |
| Fluorometer, For Clinical Use | KHO | Class 1 | Clinical Chemistry | No | 2017-10-17 |
Proprietary Names
Quidel Triage(R) MeterPro
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility