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FDA 510(k)

ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM)

K-Number: K160757 · 2016-07-26

ApplicantAxis-Shield Diagnostics Limited
Decision Date2016-07-26
Product CodeCDD
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM) is a medical device manufactured by Axis-Shield Diagnostics Limited. It received FDA 510(k) clearance on 2016-07-26 under approval number K160757. 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 ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM)?

ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM) is a medical device that received FDA 510(k) clearance on 2016-07-26. It is manufactured by Axis-Shield Diagnostics Limited. The 510(k) number is K160757.

When was ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM) approved by the FDA?

ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM) received FDA 510(k) clearance on 2016-07-26, under approval number K160757.

What company makes ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM)?

ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM) is manufactured by Axis-Shield Diagnostics Limited.

What is the FDA product code for ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM)?

The FDA product code for ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM) is CDD.

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Related PubMed Literature

PMID: 42119715 Integrated chemical and molecular authentication of Pinellia tuber: A multinational collaboration within the FHH ATLAS project with government regulatory agencies from seven countries and regions. Fitoterapia (2026) PMID: 41623865 Case Report: Hypertensive encephalopathy presents with complex types of sleep breathing events. Frontiers in cardiovascular medicine (2025) PMID: 41555155 Enhanced Fatigue Performance of VAR/EBR Nitinol for Transcatheter Heart Valve Applications: Material Characterization and Design Implications. Journal of biomedical materials research. Part B, Applied biomaterials (2026) PMID: 41412773 Good storage practices for medical devices and in vitro diagnostic medical devices by healthcare providers. Ceska a Slovenska farmacie : casopis Ceske farmaceuticke spolecnosti a Slovenske farmaceuticke spolecnosti (2025)

Other Devices by Axis-Shield Diagnostics Limited

K153551ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials. K182012ADVIA Centaur Calcitonin (CALCT) assay K183088ADVIA Centaur Erythropoietin (EPO) assay

Related Devices (Code: CDD)

K161721Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls SetDiazyme Laboratories K172133ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) AssayAxis-Shield Diagnostics, Ltd. K190298DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12Beckman Coulter Biomedical GmbH K192064LIAISON Vitamin B12DiaSorin, Inc. K223289Access Vitamin B12Beckman Coulter, Inc. K233541ARCHITECT Active-B12 (Holotranscobalamin)Axis-Shield Diagnostics, Ltd.

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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