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QUEST INTERNATIONAL, INC.

Last updated May 24, 2026

Information

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Device	Model / Reference	Registries	Class	Status
SeraQuest	H. pylori A	FDA UDI	Class I	Active
ReQuest	MUMPS G	FDA UDI	Class I	Active
ReQuest	Anti-TG	FDA UDI	Class II	Active
SeraQuest	Anti-SSA	FDA UDI	Class II	Active
SeraQuest	Syphilis G	FDA UDI	Class II	Active
SeraQuest	HSV Type 2 G	FDA UDI	Class II	Active
ReQuest	MEAS M	FDA UDI	Class I	Active
ReQuest	MEAS G	FDA UDI	Class I	Active
ReQuest	H. pylori A	FDA UDI	Class I	Active
SeraQuest	HSV Type 1 G	FDA UDI	Class II	Active
ReQuest	TOXO G	FDA UDI	Class II	Active
SeraQuest	CMV M	FDA UDI	Class II	Active
SeraQuest	EB VCA M	FDA UDI	Class I	Active
SeraQuest	Mumps M	FDA UDI	Class I	Active
ReQuest	VZV G	FDA UDI	Class II	Active
ReQuest	EB EA-D G	FDA UDI	Class I	Active
SeraQuest HSV Type 2 Specific IgG	K152353	FDA 510(k)	Class II	Active
SeraQuest HSV Type 2 Specific IgG	K181514	FDA 510(k)	Class II	Active
SeraQuest Herpes Type 1 Specific IgG	K162276	FDA 510(k)	Class II	Active

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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
Oct 1, 2025	Z-0534-2026	—	open, classified	Due to distributing the measles IgG IVD without a premarket approved/cleared.
Jul 17, 2025	Z-2552-2025	—	open, classified	Measles IgM Test Kit lacks premarket approval or clearance.
Sep 28, 2010	Z-0837-2012	—	terminated	Quest International recalled their CMV IgM Test kit because the device failed the test run due to lack of activity in the coated wells.