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FDA 510(k)

ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls

K-Number: K243575 · 2025-02-12

ApplicantBiokit, S.A.
Decision Date2025-02-12
Product CodeMYF
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls is a medical device manufactured by Biokit, S.A.. It received FDA 510(k) clearance on 2025-02-12 under approval number K243575. The device is classified under product code MYF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls?

ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls is a medical device that received FDA 510(k) clearance on 2025-02-12. It is manufactured by Biokit, S.A.. The 510(k) number is K243575.

When was ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls approved by the FDA?

ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls received FDA 510(k) clearance on 2025-02-12, under approval number K243575.

What company makes ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls?

ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls is manufactured by Biokit, S.A..

What is the FDA product code for ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls?

The FDA product code for ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls is MYF.

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

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Related Devices (Code: MYF)

K152353SeraQuest HSV Type 2 Specific IgGQuest International, Inc. K181334ADVIA Centaur Herpes-2 IgGBiokit, S.A. K181514SeraQuest HSV Type 2 Specific IgGQuest International, Inc. K220924Elecsys HSV-2 IgG (08948887160)Roche Diagnostics

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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