Raichem Spia C3 Reagent

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K911900 ↗

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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See all devices from Reagents Applications, Inc. →

• What is the Raichem Spia C3 Reagent used for?

  The Raichem Spia C3 Reagent is designed for use in immunology assays to measure complement component C3 levels. Complement C3 is a key protein in the immune system that helps regulate immune responses and identify pathogens. By quantifying C3 levels, clinicians can evaluate immune system function and assess complement pathway activity, which is useful in diagnosing and monitoring conditions related to immune deficiencies or dysregulation.

• Is the Raichem Spia C3 Reagent sterile?

  No, the Raichem Spia C3 Reagent is explicitly labeled as non-sterile. This classification is important for laboratory use, as non-sterile reagents are typically handled in controlled environments where contamination risks are managed through proper handling and facility protocols. Always follow the manufacturer’s instructions for storage and use to ensure accuracy and safety.

• Can the Raichem Spia C3 Reagent be reused?

  Yes, the Raichem Spia C3 Reagent is intended for non-single-use applications. This means it can be used multiple times within its specified shelf life, provided it is stored and handled according to the manufacturer’s guidelines. Reuse is common for certain diagnostic reagents when proper quality control measures are maintained, but always verify the reagent’s integrity before each use to avoid compromised results.

• What storage conditions are required for the Raichem Spia C3 Reagent?

  The Raichem Spia C3 Reagent requires proper storage as outlined in the accompanying documentation. While the exact conditions are not detailed here, typical recommendations for similar diagnostic reagents include storing at 2–8°C (36–46°F) to maintain stability and integrity. Avoid exposure to extreme temperatures, light, or contamination. Always refer to the product’s labeling or instructions for precise storage instructions to ensure optimal performance and longevity.

• What regulatory pathway does the Raichem Spia C3 Reagent follow?

  The Raichem Spia C3 Reagent is classified under FDA regulation number 866.5240 and falls under device class II. It received a 510(k) clearance through the traditional pathway, with a decision date of May 9, 1991. This classification and clearance indicate that the device has been evaluated for safety and effectiveness as an in vitro diagnostic tool, specifically for measuring complement C3 levels in immunology assays. The product is not intended for in vivo use.