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Sign in to claim this brandQuidel Cardiovascular Inc.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 9975 Summers Ridge Road, San Diego, CA, 92121
- Website
- —
- —
- —
- —
- 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.
| 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. |