Phadezym Ige Prist Test

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

510(k) Number

K810507 ↗

FDA Product Code

DGC

Device Class

Class II

Regulation

21 CFR Part 866.5510

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Phadebas Rast Allergen Discs

  Class II

  FDA 510(k) K823841 Active Cleared 12 Jan 1983

• Phadebact Strep F Test

  Class I

  FDA 510(k) K830445 Active Cleared 27 Apr 1983

• Delfia Plate Fluorometer 1232

  Class I

  FDA 510(k) K895240 Active Cleared 4 Oct 1989

• Mastercap Am 5.0/Mastercap Rm 5.0

  Class I

  FDA 510(k) K970420 Active Cleared 30 Jun 1997

• Phadebas Igg Rast Test

  Class II

  FDA 510(k) K810694 Active Cleared 23 Jul 1981

• Delfia Progesterone Kit

  Class I

  FDA 510(k) K890428 Active Cleared 23 Feb 1989

See all devices from Pharmacia, Inc. →

• What is the primary purpose of the Phadezym IgE PRIST Test?

  This device is designed for use in clinical laboratory settings to assist healthcare professionals in the detection and measurement of immunoglobulin E (IgE) in patient samples.

• What is the regulatory status of this device?

  The Phadezym IgE PRIST Test is a Class II medical device that has received FDA 510(k) clearance under the product code DGC, indicating it has been found substantially equivalent to legally marketed predicate devices.

• Which medical specialty is this test associated with?

  This device is categorized under the immunology medical specialty, as it is used to identify and quantify specific immunological components, specifically IgE, antigens, antisera, and controls.