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FDA 510(k)

ARCHITECT Active-B12 (Holotranscobalamin)

K-Number: K233541 · 2024-07-31

ApplicantAxis-Shield Diagnostics, Ltd.
Decision Date2024-07-31
Product CodeCDD
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ARCHITECT Active-B12 (Holotranscobalamin) is the device name listed in this FDA 510(k) record. The listed applicant is Axis-Shield Diagnostics, Ltd.. It received FDA 510(k) clearance on 2024-07-31 under 510(k) number K233541. The device is classified under product code CDD. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARCHITECT Active-B12 (Holotranscobalamin)?

ARCHITECT Active-B12 (Holotranscobalamin) is a medical device that received FDA 510(k) clearance on 2024-07-31. The listed applicant is Axis-Shield Diagnostics, Ltd.. The 510(k) number is K233541.

When did ARCHITECT Active-B12 (Holotranscobalamin) receive FDA 510(k) clearance?

ARCHITECT Active-B12 (Holotranscobalamin) received FDA 510(k) clearance on 2024-07-31, under 510(k) number K233541.

Who is the listed applicant for ARCHITECT Active-B12 (Holotranscobalamin)?

The FDA 510(k) record lists Axis-Shield Diagnostics, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARCHITECT Active-B12 (Holotranscobalamin)?

The FDA product code for ARCHITECT Active-B12 (Holotranscobalamin) is CDD.

Other records listing Axis-Shield Diagnostics, Ltd. 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.

K253539Alere NT-proBNP for Alinity iK241176Alere NT-proBNP for Alinity i Reagent KitK183088ADVIA Centaur Erythropoietin (EPO) assayK182012ADVIA Centaur Calcitonin (CALCT) assayK172133ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) AssayK153551ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials.

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Related Devices (Code: CDD)

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.

K223289Access Vitamin B12Beckman Coulter, Inc.K190298DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12Beckman Coulter Biomedical GmbHK192064LIAISON Vitamin B12DiaSorin, Inc.K172133ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) AssayAxis-Shield Diagnostics, Ltd.K161721Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls SetDiazyme LaboratoriesK160757ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM)Axis-Shield Diagnostics Limited

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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