FDA Registration
Active
🇺🇸 United States
Quidel Cardiovascular Inc.
Reg #: 3013982035
·
FEI: 3013982035
·
Expires 2026
Products
20
Proprietary Names
31
Establishment Types
3
Classifications
20
Registration Details
- Registration Name
- Quidel Cardiovascular Inc.
- Registration Number
- 3013982035
- FEI Number
- 3013982035
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 9975 Summers Ridge Road, --
- City
- San Diego
- State
- CA
- ZIP
- 92121
- Country
- US
Regulatory Submissions
- 510(k) Number
- K000231
Owner / Operator
- Firm Name
- QuidelOrtho Corporation
- 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 |
|---|---|---|---|---|---|
| Enzyme Immunoassay, Barbiturate | DIS | Class 2 | Clinical Toxicology | No | 2017-10-17 |
| Enzyme Immunoassay, Benzodiazepine | JXM | Class 2 | Clinical Toxicology | No | 2017-10-17 |
| Fluorometric Method, Cpk Or Isoenzymes | JHX | Class 2 | Clinical Chemistry | No | 2017-10-17 |
| Test, Natriuretic Peptide | NBC | Class 2 | Clinical Chemistry | No | 2017-10-17 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2017-10-17 |
| Placental Growth Factor Test | PZN | Class N | Unknown | No | 2017-11-02 |
| Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control | DAP | Class 2 | Hematology | No | 2017-10-17 |
| Radioimmunoassay, Tricyclic Antidepressant Drugs | LFG | Class 2 | Clinical Toxicology | No | 2022-10-14 |
| Drug Mixture Control Materials | DIF | Class 1 | Clinical Toxicology | No | 2019-06-24 |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | Class 1 | Clinical Chemistry | No | 2017-10-17 |
| Fibrin Split Products | GHH | Class 2 | Hematology | No | 2017-10-17 |
| 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 |
| Fluorometer, For Clinical Use | KHO | Class 1 | Clinical Chemistry | No | 2017-10-17 |
| Enzyme Immunoassay, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2017-10-17 |
| Enzyme Immunoassay, Methadone | DJR | Class 2 | Clinical Toxicology | No | 2017-10-17 |
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2017-10-17 |
| Gas Chromatography, Methamphetamine | LAF | Class 2 | Clinical Toxicology | No | 2017-11-15 |
| Enzyme Immunoassay, Cocaine | JXO | Class 2 | Clinical Toxicology | No | 2017-10-17 |
| Enzyme Immunoassay, Cannabinoids | LDJ | Class 2 | Clinical Toxicology | No | 2017-10-17 |
Proprietary Names
Quidel Triage(R) TOX Drug Screen, 94600
Quidel Triage(R) Cardiac Panel
Quidel Triage(R) Profiler SOB Panel
Quidel Triage(R) Cardio3 Panel
Quidel Triage(R) Cardio2 Panel
Quidel Triage NT-proBNP Test
Quidel Triage(R) BNP Test
Quidel Triage(R) BNP Calibration Verification
Quidel Triage(R) PLGF Test
Quidel Triage(R) D-Dimer Test
Quidel Triage TOX Drug Screen, 94600 Control 2
Quidel Triage TOX Drug Screen, 94600 Control 1
Quidel Triage(R) Total 5 Calibration Verification
Quidel Triage(R) Total 5 Control 1
Quidel Triage(R) Total 5 Control 2
Quidel Triage(R) BNP Control 1
Quidel Triage(R) BNP Control 2
Quidel Triage(R) Troponin I Test
Quidel TriageTrue(R) High Sensitivity Troponin I Test
Quidel Triage(R) MeterPro
Quidel Triage(R) Total 3 Control 2
Quidel Triage(R) Total 3 Control 1
Quidel Triage(R) TOX Drug Screen, 94600 Control 2
Quidel Triage(R) TOX Drug Screen, 94600 Control 1
Quidel Triage(R) PLGF Control 2
Quidel Triage(R) NT-proBNP Control 1
Quidel Triage(R) NT-proBNP Control 2
Quidel Triage(R) PLGF Control 1
Quidel Triage(R) Cardiac Panel, CKMB and TnI
Quidel Triage(R) Cardiac Panel, TnI
Quidel Triage TOX Drug Screen, 94600
Establishment Types
Manufacture Device in the United States for Export Only
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility