Product code GQW— Microbiology
DIAGNOSTIC HYBRIDS D3 DFA VARICELLA-ZOSTER VIRUS IDENTIFICATION KIT, 01-020000
- Classification name
- Antigen, Cf, (Including Cf Control), Varicella-Zoster
- Device class
- Class 2
- Regulation
- 21 CFR 866.3900
- Advisory panel
- Microbiology
- Total cleared
- 10
- First cleared
- Most recent
Market context for product code GQW
FDA has cleared devices under product code GQW between 1980 and 2007, filed by 9 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2007
- 1999
- 1997
- 1994
- 1991
- 1990
- 1989
- 1985
- 1980
Top applicants under product code GQW
Recent clearances under product code GQW
- K070206 — DIAGNOSTIC HYBRIDS D3 DFA VARICELLA-ZOSTER VIRUS IDENTIFICATION KIT, 01-020000
- K990141 — LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 3295
- K964872 — VZV ANTIGEN CONTROL SLIDES
- K942743 — VIRO VARICELLA-ZOSTER VIRUS IDENTIFICATION REAGENT
- K912239 — VZVSCAN(TM) LATEX AGGUTINATION TEST
- K903882 — VARICELLA-ZOSTER VIRUS ANTIBODY TEST KIT-LATEX AGG
- K894622 — VARICELLA ZOSTER VIRUS
- K843676 — VARICELLA/ZOSTER VIRUS
- K841434 — VARICELLA-ZOSTER(IGG) IFA TEST
- K802938 — VARICELLA-ZOSTER ANTIGENS & CONTROLS
Data sourced from openFDA. This site is unofficial and independent of the FDA.