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Gilford C3 Complement Reagent

by Gilford

510(k) K853466

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK853466 Date16 Sep 1985ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
CZW
Device Class
Class II
Regulation
21 CFR Part 866.5240
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This is an immunological reagent kit for the detection and quantification of complement C3, the most abundant protein of the complement system and a central component in both the classical and alternative activation pathways. The kit includes antigen, antiserum, and control components for use in clinical immunology laboratories.

The device is classified as a Class II medical device under FDA regulation number 866.5240 with product code CZW. It received traditional 510(k) clearance (K853466) on September 16, 1985, and is substantially equivalent to a legally marketed predicate device.

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Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What components are included in the Gilford C3 Complement Reagent kit?

    The kit contains the specific C3 antigen, a matching antiserum, and control materials. These components allow laboratories to perform both detection and quantification of complement C3 in a single, standardized assay, ensuring consistent results across runs.

  • Is the Gilford C3 Complement Reagent intended for single‑use or can it be reused?

    The kit is supplied as a single‑use, disposable set. Each component is packaged to maintain sterility and performance for one assay, preventing cross‑contamination and preserving the accuracy of quantitative measurements.

  • How is the kit supplied and stored before use?

    The reagents are provided in sealed vials or containers that maintain sterility. They should be stored according to the manufacturer’s instructions, typically at refrigerated temperatures (2‑8 °C) to preserve activity until the expiration date indicated on the label.

  • What regulatory pathway was used for the Gilford C3 Complement Reagent?

    The device received traditional 510(k) clearance (K853466) on September 16 1985, indicating it was found substantially equivalent to a legally marketed predicate device under FDA Class II regulations (product code CZW).