Complement C3 Reagent System

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K800212 ↗

FDA Product Code

CZW

Device Class

Class II

Regulation

21 CFR Part 866.5240

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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• Enzygnost Tm Rubella Igm

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See all devices from Calbiochem-Behring Corp. →

• What is the Complement C3 Reagent System used for?

  The Complement C3 Reagent System is used for the detection and quantification of complement C3, a central component in both the classical and alternative activation pathways, in clinical immunology laboratories.

• Is the Complement C3 Reagent System single-use or reusable?

  The device is not specified as single-use or reusable in the provided data.

• What are the storage and handling instructions for the Complement C3 Reagent System?

  Storage and handling instructions are not provided in the device data.

• What is the product code for the Complement C3 Reagent System?

  The product code for the Complement C3 Reagent System is CZW.