Quest International, Inc.

Medical device manufacturer in Doral, FL.

3510(k) clearances
0PMA approvals
3recalls

Device types

510(k) clearances

510(k)DeviceDecision
K181514SeraQuest HSV Type 2 Specific IgGMYF · Traditional 06/13/2019SE
K162276SeraQuest Herpes Type 1 Specific IgGMXJ · Traditional 10/01/2016SE
K152353SeraQuest HSV Type 2 Specific IgGMYF · Traditional 05/13/2016SE

Recalls

RecallProductInitiated
Z-0534-2026 Class IIBrand Name: ReQuest Measles IgG Product Name: Rubeola IgG Enzyme Linked Immunoabsorbant…Due to distributing the measles IgG IVD without a premarket approved/cleared. 10/01/2025Open, Classified
Z-2552-2025 Class IIBrand Name: ReQuest Measles IgM Product Name: Enzyme Linked Immunoabsorbant Assay…Measles IgM Test Kit lacks premarket approval or clearance. 07/17/2025Open, Classified
Z-0837-2012 SeraQuest***CMV IgM TEST SET For the detection of CMV IgM Antibodies 96 Test Set Cat.…Quest International recalled their CMV IgM Test kit because the device failed the test run due to lack of… 09/28/2010Terminated