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510(k) K942743

VIRO VARICELLA-ZOSTER VIRUS IDENTIFICATION REAGENT by Viro Research, Inc. — Product Code GQW

K942743 is an FDA 510(k) premarket notification submitted by Viro Research, Inc. for the device "VIRO VARICELLA-ZOSTER VIRUS IDENTIFICATION REAGENT". The FDA issued a decision of Substantially Equivalent on December 15, 1994. The device falls under product code GQW (Antigen, Cf, (Including Cf Control), Varicella-Zoster), a Class II device regulated under 21 CFR 866.3900.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 1994
Date Received
June 10, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigen, Cf, (Including Cf Control), Varicella-Zoster
Device Class
Class II
Regulation Number
866.3900
Review Panel
MI
Submission Type

Other clearances for product code GQW

  • K070206 — DIAGNOSTIC HYBRIDS D3 DFA VARICELLA-ZOSTER VIRUS IDENTIFICATION KIT, 01-020000 (August 30, 2007)
  • K990141 — LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 3295 (October 19, 1999)
  • K964872 — VZV ANTIGEN CONTROL SLIDES (March 18, 1997)
  • K912239 — VZVSCAN(TM) LATEX AGGUTINATION TEST (June 11, 1991)
  • K903882 — VARICELLA-ZOSTER VIRUS ANTIBODY TEST KIT-LATEX AGG (December 4, 1990)
  • K894622 — VARICELLA ZOSTER VIRUS (October 24, 1989)
  • K843676 — VARICELLA/ZOSTER VIRUS (September 26, 1985)
  • K841434 — VARICELLA-ZOSTER(IGG) IFA TEST (April 19, 1985)
  • K802938 — VARICELLA-ZOSTER ANTIGENS & CONTROLS (December 31, 1980)

FDA data resources