FDA 510(k)

ADVIA Centaur Herpes-1 IgG

K-Number: K181333 · 2018-08-23

Decision Date2018-08-23

Product CodeMXJ

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

ADVIA Centaur Herpes-1 IgG is a medical device manufactured by Biokit, S.A.. It received FDA 510(k) clearance on 2018-08-23 under approval number K181333. 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 ADVIA Centaur Herpes-1 IgG?

ADVIA Centaur Herpes-1 IgG is a medical device that received FDA 510(k) clearance on 2018-08-23. It is manufactured by Biokit, S.A.. The 510(k) number is K181333.

When was ADVIA Centaur Herpes-1 IgG approved by the FDA?

ADVIA Centaur Herpes-1 IgG received FDA 510(k) clearance on 2018-08-23, under approval number K181333.

What company makes ADVIA Centaur Herpes-1 IgG?

ADVIA Centaur Herpes-1 IgG is manufactured by Biokit, S.A..

What is the FDA product code for ADVIA Centaur Herpes-1 IgG?

The FDA product code for ADVIA Centaur Herpes-1 IgG is MXJ.

Other Devices by Biokit, S.A.

K152185ARCHITECT SHBG K181334ADVIA Centaur Herpes-2 IgG K213987ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls K214068Quantia IgE K233606ADVIA Centaur EBV-VCA IgM K233605ADVIA Centaur EBV-EBNA IgG

View all 8 devices →

Related Devices (Code: MXJ)

K162276SeraQuest Herpes Type 1 Specific IgGQuest International, Inc. 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

View on FDA Database →

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