ClearanceBrief
Company ยท US

Quest International, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 2016 to 2019. Name variants (Inc, Corp, punctuation) are merged.

3510(k) clearances (0 in 12 months)
3recalls (1 in 12 months)
1recalls that name a 510(k)

Product codes

CodeDeviceRecords
MYFEnzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-22
LJBEnzyme Linked Immunoabsorbent Assay, Rubeola Igg1
LKQAntibody Igm,If, Cytomegalovirus Virus1
MXJEnzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-11
PCLEnzyme Linked Immunoabsorbent Assay, Rubeola Igm1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Jun 13, 2019K181514SeraQuest HSV Type 2 Specific IgG
Quest International, Inc.
MYF
Oct 1, 2016K162276SeraQuest Herpes Type 1 Specific IgG
Quest International, Inc.
MXJ
May 13, 2016K152353SeraQuest HSV Type 2 Specific IgG
Quest International, Inc.
MYF

Latest recalls

DateFirm and productCodeLinked 510(k)
Nov 17, 2025Quest International, Inc.
Brand Name: ReQuest Measles IgG Product Name: Rubeola IgG Enzyme Linked Immunoabsorbant Assay Model/Catalog Number: 01-190 Software Version: N/A Product Description: Measles IgG tests, performed using
Open, Classified		 LJBNone listed
Sep 11, 2025Quest International, Inc.
Brand Name: ReQuest Measles IgM Product Name: Enzyme Linked Immunoabsorbant Assay, Rubeola IgM Model/Catalog Number: 01-190M Software Version: N/A Product Description: Measles IgM tests, performed usi
Open, Classified		 PCLNone listed
Jan 23, 2012Quest International, Inc.
SeraQuest***CMV IgM TEST SET For the detection of CMV IgM Antibodies 96 Test Set Cat. No. 01-150 Store 2-8 C For In Vitro Diagnostic Use***Contents: 1 96 wells bag with holder, 1 Negative Control*, 1
Terminated		 LKQK982485
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