Gilford Immunoglobulin A Reagent

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

510(k) Number

K853467 ↗

FDA Product Code

CZP

Device Class

Class II

Regulation

21 CFR Part 866.5510

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Gilford Immunoglobulin M Reagent

  Class II

  FDA 510(k) K853469 Active Cleared 16 Sep 1985

• 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

See all devices from Gilford →

• What is the Gilford Immunoglobulin A Reagent used for?

  The Gilford Immunoglobulin A Reagent is used to measure immunoglobulins A, G, M, D, and E in serum using immunochemical techniques. This measurement aids in the diagnosis of abnormal protein metabolism and the body's reduced ability to resist infectious agents, as stated in the device description.

• How is the Gilford Immunoglobulin A Reagent supplied and what is its classification?

  The device is supplied as a reagent for immunochemical testing and is classified as a Class II medical device under FDA regulation number 866.5510 with product code CZP. This classification and supply format are specified in the device data.

• What regulatory clearance does the Gilford Immunoglobulin A Reagent have and when was it granted?

  The Gilford Immunoglobulin A Reagent received traditional 510(k) clearance (K853467) from the FDA on September 16, 1985, based on substantial equivalence to a legally marketed device. This information is explicitly provided in the device data under AUTHORIZATIONS and SPECIFICATIONS.