GQW · Class II · 21 CFR 866.3900

FDA Product Code GQW: Antigen, Cf, (including Cf Control), Varicella-zoster

Leading manufacturers include Diagnostic Hybrids, Inc., Orion Diagnostica, Inc. and Zeus Scientific, Inc..

10
Total
10
Cleared
180d
Avg days
1980
Since

FDA 510(k) Cleared Antigen, Cf, (including Cf Control), Varicella-zoster Devices (Product Code GQW)

10 devices
1–10 of 10
Cleared Aug 30, 2007
DIAGNOSTIC HYBRIDS D3 DFA VARICELLA-ZOSTER VIRUS IDENTIFICATION KIT, 01-020000
K070206
Diagnostic Hybrids, Inc.
Microbiology · 220d
Cleared Oct 19, 1999
LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 3295
K990141
Light Diagnostics
Microbiology · 273d
Cleared Jun 11, 1991
VZVSCAN(TM) LATEX AGGUTINATION TEST
K912239
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 21d
Cleared Apr 19, 1985
VARICELLA-ZOSTER(IGG) IFA TEST
K841434
Zeus Scientific, Inc.
Microbiology · 378d
Cleared Dec 31, 1980
VARICELLA-ZOSTER ANTIGENS & CONTROLS
K802938
Orion Diagnostica, Inc.
Microbiology · 42d

About Product Code GQW - Regulatory Context