Virgo Reagents Indirect Fluorscent

No FDA recalls found in the data synced 10 Oct 2026.

510(k) Number

K841127 ↗

FDA Product Code

DHN

Device Class

Class II

Regulation

21 CFR Part 866.5100

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Lipase Hydrolysis/Glycerol Kinase, Triglycerides

  Class I

  FDA 510(k) K863874 Active Cleared 13 Nov 1986

• Toxoplasma Gondii Igg Elisa

  Class II

  FDA 510(k) K871905 Active Cleared 30 Jul 1987

• Gemeni Igm Assay

  Class II

  FDA 510(k) K800450 Active Cleared 24 Apr 1980

• Herpes Ident. & Typing Test Hitt

  Class II

  FDA 510(k) K831504 Active Cleared 20 Sep 1983

• Gemeni Igg Assay

  Class II

  FDA 510(k) K800451 Active Cleared 24 Apr 1980

• Gemstar System

  Class I

  FDA 510(k) K821335 Active Cleared 13 Jul 1982

See all devices from Electro-Nucleonics Laboratories, Inc. →