GQW — Antigen, Cf, (Including Cf Control), Varicella-Zoster Class II
FDA product code GQW covers "Antigen, Cf, (Including Cf Control), Varicella-Zoster", a Class II medical device regulated under 21 CFR 866.3900. Submissions are reviewed by the Microbiology panel. At least 10 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GQW
- Device Class
- Class II
- Regulation Number
- 866.3900
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K070206 | diagnostic hybrids | DIAGNOSTIC HYBRIDS D3 DFA VARICELLA-ZOSTER VIRUS IDENTIFICATION KIT, 01-020000 | August 30, 2007 |
| K990141 | light diagnostics | LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 3295 | October 19, 1999 |
| K964872 | viral antigens | VZV ANTIGEN CONTROL SLIDES | March 18, 1997 |
| K942743 | viro research | VIRO VARICELLA-ZOSTER VIRUS IDENTIFICATION REAGENT | December 15, 1994 |
| K912239 | bd becton dickinson vacutainer systems preanalytic | VZVSCAN(TM) LATEX AGGUTINATION TEST | June 11, 1991 |
| K903882 | viral antigens | VARICELLA-ZOSTER VIRUS ANTIBODY TEST KIT-LATEX AGG | December 4, 1990 |
| K894622 | bion ent | VARICELLA ZOSTER VIRUS | October 24, 1989 |
| K843676 | institute virion | VARICELLA/ZOSTER VIRUS | September 26, 1985 |
| K841434 | zeus scientific | VARICELLA-ZOSTER(IGG) IFA TEST | April 19, 1985 |
| K802938 | orion diagnostica | VARICELLA-ZOSTER ANTIGENS & CONTROLS | December 31, 1980 |