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FDA 510(k)

ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials.

K-Number: K153551 · 2016-08-04

ApplicantAxis-Shield Diagnostics Limited
Decision Date2016-08-04
Product CodeNHX
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials. is a medical device manufactured by Axis-Shield Diagnostics Limited. It received FDA 510(k) clearance on 2016-08-04 under approval number K153551. The device is classified under product code NHX. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials.?

ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials. is a medical device that received FDA 510(k) clearance on 2016-08-04. It is manufactured by Axis-Shield Diagnostics Limited. The 510(k) number is K153551.

When was ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials. approved by the FDA?

ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials. received FDA 510(k) clearance on 2016-08-04, under approval number K153551.

What company makes ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials.?

ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials. is manufactured by Axis-Shield Diagnostics Limited.

What is the FDA product code for ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials.?

The FDA product code for ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials. is NHX.

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Other Devices by Axis-Shield Diagnostics Limited

K160757ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM) K182012ADVIA Centaur Calcitonin (CALCT) assay K183088ADVIA Centaur Erythropoietin (EPO) assay

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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