Virgo(R) Vzv-Igg Elisa

• • Terminated Z-2445-2012 FDA Class III ·initiated 29 May 2012

  The Positive Control for the Captia Varicella-Zoster Virus (VZV) IgG Kit has been reported as running high out of its assigned ISR range.

510(k) Number

K883427 ↗

FDA Product Code

GQX

Device Class

Class II

Regulation

21 CFR Part 866.3900

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Virgo (R) Cmv-Igg Elisa

  Class II

  FDA 510(k) K883102 Active Cleared 8 Feb 1989

• Lactate Dehydrogenase Ldh

  Class II

  FDA 510(k) K883206 Active Cleared 9 Sep 1988

• Deltatest (R) Lipase II

  Class I

  FDA 510(k) K893718 Active Cleared 28 Sep 1989

• Gen Profiler System

  Class I

  FDA 510(k) K851619 Active Cleared 14 May 1985

• Virgo(R) Microwell Alt Assay

  Class I

  FDA 510(k) K884784 Active Cleared 29 Dec 1988

• Serological Test Kit for Igg Anti. Epstein-Barr VI

  Class I

  FDA 510(k) K883670 Active Cleared 28 Apr 1989

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