Quidel Cardiovascular, Inc.

Medical device manufacturer in San Diego, CA.

2510(k) clearances
0PMA approvals
2recalls

Device types

510(k) clearances

510(k)DeviceDecision
K200363Quidel Triage® TOX Drug Screen, 94600DKZ · Special 03/11/2020SE
K182719Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterProDKZ · Traditional 06/19/2019SE

Recalls

RecallProductInitiated
Z-1974-2023 Class IQuidel Triage Cardiac Panel: REF: 97000HS, 97021HS (Troponin I), 97022HS (CK-MB and…Raw material issue may cause cardiac panel products to have an average of 30% troponin signal reduction… 05/25/2023Open, Classified
Z-1552-2020 Class IIQuidel Triage TOX Drug Screen Control 1 Kit Box containing 5 Control 1 vials with 5 x…Due to an error in the programming of the Control CODE CHIP module for this lot, a failing result is… 04/09/2019Terminated