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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 the device name listed in this FDA 510(k) record. The listed applicant is Biokit, S.A.. It received FDA 510(k) clearance on 2025-02-12 under 510(k) 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. The listed applicant is Biokit, S.A.. The 510(k) number is K243575.

When did ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls receive FDA 510(k) clearance?

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

Who is the listed applicant for ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls?

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 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 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.

K233606ADVIA Centaur EBV-VCA IgMK233605ADVIA 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

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Related Devices (Code: MYF)

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.

K220924Elecsys HSV-2 IgG (08948887160)Roche DiagnosticsK181514SeraQuest HSV Type 2 Specific IgGQuest International, Inc.K181334ADVIA Centaur Herpes-2 IgGBiokit, S.A.K152353SeraQuest HSV Type 2 Specific IgGQuest International, 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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