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FDA 510(k)

ADVIA Centaur EBV-EBNA IgG

K-Number: K233605 · 2024-08-07

ApplicantBiokit, S.A.
Decision Date2024-08-07
Product CodeLLM
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ADVIA Centaur EBV-EBNA IgG is a medical device manufactured by Biokit, S.A.. It received FDA 510(k) clearance on 2024-08-07 under approval number K233605. The device is classified under product code LLM. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADVIA Centaur EBV-EBNA IgG?

ADVIA Centaur EBV-EBNA IgG is a medical device that received FDA 510(k) clearance on 2024-08-07. It is manufactured by Biokit, S.A.. The 510(k) number is K233605.

When was ADVIA Centaur EBV-EBNA IgG approved by the FDA?

ADVIA Centaur EBV-EBNA IgG received FDA 510(k) clearance on 2024-08-07, under approval number K233605.

What company makes ADVIA Centaur EBV-EBNA IgG?

ADVIA Centaur EBV-EBNA IgG is manufactured by Biokit, S.A..

What is the FDA product code for ADVIA Centaur EBV-EBNA IgG?

The FDA product code for ADVIA Centaur EBV-EBNA IgG is LLM.

Other Devices by Biokit, S.A.

K152185ARCHITECT SHBG K181333ADVIA Centaur Herpes-1 IgG 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

View all 8 devices →

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.

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