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FDA 510(k)

ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay

K-Number: K172133 · 2017-10-27

ApplicantAxis-Shield Diagnostics, Ltd.
Decision Date2017-10-27
Product CodeCDD
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay is a medical device manufactured by Axis-Shield Diagnostics, Ltd.. It received FDA 510(k) clearance on 2017-10-27 under approval number K172133. 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 (Holotranscobalamin) (AB12) Assay is a medical device that received FDA 510(k) clearance on 2017-10-27. It is manufactured by Axis-Shield Diagnostics, Ltd.. The 510(k) number is K172133.

When was ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay approved by the FDA?

ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay received FDA 510(k) clearance on 2017-10-27, under approval number K172133.

What company makes ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay?

ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay is manufactured by Axis-Shield Diagnostics, Ltd..

What is the FDA product code for ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay?

The FDA product code for ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay is CDD.

Other Devices by Axis-Shield Diagnostics, Ltd.

K233541ARCHITECT Active-B12 (Holotranscobalamin) K241176Alere NT-proBNP for Alinity i Reagent Kit K253539Alere NT-proBNP for Alinity i

Related Devices (Code: CDD)

K161721Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls SetDiazyme Laboratories K160757ADVIA 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 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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