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FDA 510(k)

ADVIA Centaur EBV-VCA IgM

K-Number: K233606 · 2024-08-07

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

Device Summary

ADVIA Centaur EBV-VCA IgM 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 K233606. The device is classified under product code LSE. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADVIA Centaur EBV-VCA IgM?

ADVIA Centaur EBV-VCA IgM 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 K233606.

When did ADVIA Centaur EBV-VCA IgM receive FDA 510(k) clearance?

ADVIA Centaur EBV-VCA IgM received FDA 510(k) clearance on 2024-08-07, under 510(k) number K233606.

Who is the listed applicant for ADVIA Centaur EBV-VCA IgM?

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-VCA IgM?

The FDA product code for ADVIA Centaur EBV-VCA IgM is LSE.

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 ControlsK233605ADVIA Centaur EBV-EBNA IgGK213987ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG ControlsK214068Quantia IgEK181334ADVIA Centaur Herpes-2 IgGK181333ADVIA Centaur Herpes-1 IgG

View all 8 devices →

Related Devices (Code: LSE)

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.

K162961LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control SetDiaSorin, Inc.K162959LIAISON® EA IgG and LIAISON® EA IgG Serum Control SetDiaSorin, Inc.

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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