FDA 510(k)

ADVIA Centaur EBV-EBNA IgG

K-Number: K233605 · 2024-08-07

Decision Date2024-08-07

Product CodeLLM

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

ADVIA Centaur EBV-EBNA IgG is the device name listed in this FDA 510(k) record. The listed applicant is Biokit, S.A.. It received FDA 510(k) clearance on 2024-08-07 under 510(k) 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. The listed applicant is Biokit, S.A.. The 510(k) number is K233605.

When did ADVIA Centaur EBV-EBNA IgG receive FDA 510(k) clearance?

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

Who is the listed applicant for ADVIA Centaur EBV-EBNA IgG?

The FDA 510(k) record lists Biokit, S.A. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Biokit, S.A. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243575ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls K233606ADVIA Centaur EBV-VCA IgM K213987ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls K214068Quantia IgE K181334ADVIA Centaur Herpes-2 IgG K181333ADVIA Centaur Herpes-1 IgG

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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.