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Sign in to claim this brandQuidel Cardiovascular Inc.
US
Last updated September 17, 2026
What Quidel Cardiovascular Inc. makes
Quidel Cardiovascular Inc. manufactures in vitro diagnostic (IVD) devices for cardiac marker testing, including kits and controls for fluorescent immunoassays of troponin I, B-type natriuretic peptide (BNP), N-terminal proBNP, and D-dimer. Their portfolio also includes point-of-care fluorescent immunoassay analysers and controls for drug-of-abuse testing, primarily branded under the Triage series.
The company’s devices are classified under FDA’s Class I and Class II regulations, with some listed as exempt (Class N). All relevant products are registered in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Quidel Cardiovascular Inc. manufacture?
Quidel Cardiovascular Inc. specializes in in vitro diagnostic (IVD) devices focused on cardiac marker testing. Their portfolio includes kits and controls for fluorescent immunoassays, such as troponin I, B-type natriuretic peptide (BNP), N-terminal proBNP, and D-dimer. They also produce point-of-care fluorescent immunoassay analysers and controls for drug-of-abuse testing, primarily under the Triage brand. These devices are designed for rapid, accurate diagnostic testing in clinical settings.
Where is Quidel Cardiovascular Inc. based?
Quidel Cardiovascular Inc. is headquartered in the United States. The company’s location is relevant for regulatory oversight, as it operates under the jurisdiction of the U.S. Food and Drug Administration (FDA). This positioning also influences the regulatory pathways and compliance requirements for its devices.
Which regulatory registries list Quidel Cardiovascular Inc.’s devices?
Quidel Cardiovascular Inc.’s devices are registered in the FDA’s Unique Device Identifier (UDI) database. The UDI system is a standardized approach to identify medical devices throughout their distribution and use, ensuring traceability and compliance with U.S. regulatory requirements. This registry is critical for tracking and monitoring the devices’ lifecycle and adherence to safety standards.
How are Quidel Cardiovascular Inc.’s devices classified under U.S. regulations?
Quidel Cardiovascular Inc.’s devices fall under FDA’s Class I and Class II classifications, with some listed as exempt (Class N). Class I devices generally pose minimal risk and may require less regulatory scrutiny, while Class II devices involve moderate risk and require special controls to ensure safety and effectiveness. Class N exemptions indicate that certain devices are not subject to premarket notification (510(k)) requirements due to their low risk, but they still must comply with general controls and labeling requirements.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- 9975 Summers Ridge Road, San Diego, CA, 92121
- Website
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- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3013982035
- DUNS Number
- —
Catalogue (43)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Triage | 97500EU | FDA UDI | Class II | Active |
| Triage | 98100EU | FDA UDI | Class II | Active |
| Triage | 97000HSEU | FDA UDI | Class II | Active |
| Triage | 98000XR | FDA UDI | Class II | Active |
| Triage | 94600 | FDA UDI | Class II | Active |
| Triage | 94402 | FDA UDI | Class II | Unknown |
| Triage | 98700EU | FDA UDI | Class II | Active |
| Triage | 98201 | FDA UDI | Class I | Active |
| Triage | 98714EU | FDA UDI | Class I | Active |
| Triage | 98813EU | FDA UDI | Class I | Active |
| Triage | 98200 | FDA UDI | Class II | Active |
| Triage | 94613 | FDA UDI | Class I | Active |
| Triage | 98600EU | FDA UDI | Class II | Active |
| Triage | 94614 | FDA UDI | Class I | Active |
| Triage | 88753 | FDA UDI | Class I | Active |
| Triage | 94400EU | FDA UDI | Class II | Unknown |
| Triage | 97000HS | FDA UDI | Class II | Active |
| Triage | 98800EU | FDA UDI | N | Active |
| Triage | 98713EU | FDA UDI | Class I | Active |
| Triage | 88755 | FDA UDI | Class I | Active |
| Triage | 55070 | FDA UDI | Class II | Active |
| Triage | 98814EU | FDA UDI | Class I | Active |
| Triage | 88754 | FDA UDI | Class I | Active |
| Triage | 97021HS | FDA UDI | Class II | Active |
| Triage | 98100 | FDA UDI | Class II | Active |
| Triage | 97400EU | FDA UDI | Class II | Active |
| Triage | 94400 | FDA UDI | Class II | Unknown |
| Triage | 97022HS | FDA UDI | Class II | Active |
| Triage | 55071 | FDA UDI | Class II | Active |
| Triage | 94413 | FDA UDI | Class I | Unknown |
| Triage | 98014XR | FDA UDI | Class I | Active |
| Triage | 98000XREU | FDA UDI | Class II | Active |
| Triage | 94401 | FDA UDI | Class II | Unknown |
| Triage | 88734 | FDA UDI | Class I | Active |
| Triage | 94404 | FDA UDI | Class II | Unknown |
| Triage | 98015XR | FDA UDI | Class I | Active |
| Triage | 98013XR | FDA UDI | Class I | Active |
| Triage | 97300EU | FDA UDI | Class II | Active |
| Triage | 88733 | FDA UDI | Class I | Active |
| Triage | 94414 | FDA UDI | Class I | Unknown |
| Triage | 98202 | FDA UDI | Class II | Active |
| Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro | K182719 | FDA 510(k) | Class II | Active |
| Quidel Triage® TOX Drug Screen, 94600 | K200363 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Recalls (2)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Quidel Cardiovascular Inc. has two FDA recall records initiated between April 9, 2019, and May 25, 2023, with statuses including open, classified, and terminated. The first involved an error in the programming of the Control CODE CHIP module, causing incorrect failing results for AMP and mAMP tests. The second cited a raw material issue that may reduce troponin signal by up to 30% across a specified measurement range, with QC testing unable to detect the anomaly.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| May 25, 2023 | Z-1974-2023 | — | open, classified | Raw material issue may cause cardiac panel products to have an average of 30% troponin signal reduction across measurement range 0.05 ng/mL to 30 ng/mL, QC testing won't detect anomaly, so an alternate method is recommended, if unavailable, use recommendations to mitigate potential patient impact, which could be missed/delayed myocardial infarction diagnosis. |
| Apr 9, 2019 | Z-1552-2020 | — | terminated | Due to an error in the programming of the Control CODE CHIP module for this lot, a failing result is inappropriately displayed for AMP and mAMP. This issue results in the Triage Meter displaying a failing control result for the AMP and mAMP tests when the control did not fail. |