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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 a medical device manufactured by Biokit, S.A.. It received FDA 510(k) clearance on 2024-08-07 under approval 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. It is manufactured by Biokit, S.A.. The 510(k) number is K233606.

When was ADVIA Centaur EBV-VCA IgM approved by the FDA?

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

What company makes ADVIA Centaur EBV-VCA IgM?

ADVIA Centaur EBV-VCA IgM is manufactured by Biokit, S.A..

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 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 K233605ADVIA Centaur EBV-EBNA IgG

View all 8 devices →

Related Devices (Code: LSE)

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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