N Protein Standars Sy

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K955857 ↗

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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• What is the N Protein Standards SY used for in laboratory testing?

  The N Protein Standards SY serves as a reference standard for immunology assays, specifically for quantifying and validating complement C3 antigen levels in serum or plasma samples. This aids clinicians in accurately diagnosing and monitoring complement-related disorders, ensuring reliable test results for conditions influenced by complement system activity.

• How is the N Protein Standards SY supplied and intended for use?

  The N Protein Standards SY is supplied as a liquid reagent and is designed for single-use in laboratory settings. It is intended exclusively for use in immunology testing environments, adhering to regulatory standards for diagnostic reagents. This ensures consistency and accuracy in complement C3 measurements.

• Is the N Protein Standards SY sterile and how should it be stored?

  The N Protein Standards SY is a liquid reagent intended for laboratory use, but the provided data does not explicitly state whether it is sterile. For optimal performance, it should be stored according to standard laboratory practices for liquid reagents, typically at 2–8°C (refrigerated) and protected from light until use. Always refer to the product labeling for specific storage instructions.

• What regulatory approval does the N Protein Standards SY hold?

  The N Protein Standards SY has received FDA 510(k) clearance (K955857) as substantially equivalent to a predicate device under 21 CFR 866.5240. This classification ensures it meets regulatory standards for diagnostic reagents used in immunology testing, particularly for complement C3 antigen assays.

• Are there different sizes or models available for the N Protein Standards SY?

  The provided data does not specify multiple sizes or models for the N Protein Standards SY. It is described as a single reference standard reagent, intended for consistent use in complement C3 quantification. For variations or additional formats, consult the manufacturer’s catalog or technical documentation.