Gilford Immunoglobulin M Reagent

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K853469 ↗

FDA Product Code

DFT

Device Class

Class II

Regulation

21 CFR Part 866.5550

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Eia Rubella

  Class II

  FDA 510(k) K812787 Active Cleared 27 Nov 1981

• Advantage

  Class I

  FDA 510(k) K840120 Active Cleared 23 Mar 1984

• Gilford Tri-Level Assayed Immunology Control

  Class II

  FDA 510(k) K851202 Active Cleared 29 Apr 1985

• Impact 400 #1447X2

  Class I

  FDA 510(k) K833067 Active Cleared 8 Dec 1983

• Gilford Immunoglobulin G Reagent

  Class II

  FDA 510(k) K853465 Active Cleared 16 Sep 1985

• Gilford C4 Complement Reagent

  Class II

  FDA 510(k) K853468 Active Cleared 16 Sep 1985

See all devices from Gilford →

• What clinical conditions might this reagent help diagnose, and how does it work in the lab setting?

  The Gilford Immunoglobulin M (IgM) Reagent detects and measures IgM in serum, body fluids, or tissues by identifying its kappa and lambda light chains. It aids in diagnosing conditions involving abnormal light chain production, such as certain hematologic disorders like Waldenström macroglobulinemia or other immunoproliferative diseases. In the lab, it functions as part of immunochemical assays to quantify IgM levels, supporting immunology assessments under standard laboratory protocols.

• Is this reagent intended for reuse, or is it designed for single-use only? What does that mean for my lab’s workflow?

  The Gilford Immunoglobulin M Reagent is explicitly designed for single-use only. This means each vial is meant to be used once in a test, after which it should be discarded. For your lab’s workflow, this implies you’ll need to account for inventory turnover, proper labeling of expiration dates, and adherence to single-use protocols to avoid contamination or cross-reactivity between samples.

• What storage conditions are required to maintain the reagent’s efficacy, and why is this important?

  While the data doesn’t specify exact storage conditions (e.g., temperature or humidity), the reagent’s efficacy depends on controlled storage to preserve its stability. Since it’s a diagnostic tool for immunochemical assays, exposure to improper conditions (like heat or light) could degrade its performance, leading to inaccurate IgM measurements. Always follow the manufacturer’s instructions for storage to ensure reliable results.

• How do I know this reagent is safe and compliant for use in my immunology lab?

  The Gilford Immunoglobulin M Reagent holds FDA 510(k) clearance (K853469), confirming it meets regulatory standards for Class II medical devices under the Immunology advisory committee’s oversight. This clearance indicates it has been evaluated for safety and effectiveness as an immunological reagent, though compliance with lab-specific protocols (e.g., handling, documentation) remains your responsibility. Always verify the clearance status via the FDA’s database if unsure.

• Are there any special handling instructions for this reagent, such as sterility or compatibility with other lab equipment?

  The data does not mention sterility requirements or MRI safety considerations, but it is classified as a diagnostic tool for clinical immunology laboratories. Since it’s intended for single-use in immunochemical assays, standard lab hygiene practices (e.g., aseptic technique, proper disposal) should apply. Compatibility with specific lab equipment (e.g., ELISA readers, microwell plates) would depend on your lab’s existing workflows, as the reagent itself isn’t designed for multi-use or specialized environments like MRI.