FDA 510(k)

SeraQuest Herpes Type 1 Specific IgG

K-Number: K162276 · 2016-10-01

Decision Date2016-10-01

Product CodeMXJ

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

SeraQuest Herpes Type 1 Specific IgG is a medical device manufactured by Quest International, Inc.. It received FDA 510(k) clearance on 2016-10-01 under approval number K162276. The device is classified under product code MXJ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SeraQuest Herpes Type 1 Specific IgG?

SeraQuest Herpes Type 1 Specific IgG is a medical device that received FDA 510(k) clearance on 2016-10-01. It is manufactured by Quest International, Inc.. The 510(k) number is K162276.

When was SeraQuest Herpes Type 1 Specific IgG approved by the FDA?

SeraQuest Herpes Type 1 Specific IgG received FDA 510(k) clearance on 2016-10-01, under approval number K162276.

What company makes SeraQuest Herpes Type 1 Specific IgG?

SeraQuest Herpes Type 1 Specific IgG is manufactured by Quest International, Inc..

What is the FDA product code for SeraQuest Herpes Type 1 Specific IgG?

The FDA product code for SeraQuest Herpes Type 1 Specific IgG is MXJ.

Other Devices by Quest International, Inc.

K152353SeraQuest HSV Type 2 Specific IgG K181514SeraQuest HSV Type 2 Specific IgG

Related Devices (Code: MXJ)

K181333ADVIA Centaur Herpes-1 IgGBiokit, S.A. K220923Elecsys HSV-1 IgG (08948844160)Roche Diagnostics K213987ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG ControlsBiokit, S.A.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.