Viro Varicella-Zoster Virus Identification Reagent
FDA 510(k) K942743 · Viro Research, Inc.
510(k) numberK942743
Submission
- Device name
- Viro Varicella-Zoster Virus Identification Reagent
- Applicant
- Viro Research, Inc.
Rockford, IL, US - Received
- June 10, 1994
- Decision date
- December 15, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GQW – Antigen, Cf, (Including Cf Control), Varicella-Zoster
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3900
- Specialty
- Microbiology
Other 510(k)s with product code GQW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K070206 | Diagnostic Hybrids D3 Dfa Varicella-Zoster Virus Identification Kit, 01-020000GQW · Traditional | Diagnostic Hybrids, Inc. | 08/30/2007SE |
| K990141 | Light Diagnostics Simulfluor Hsv/Vzv Immunoflourescence Assay, Model 3295GQW · Traditional | Light Diagnostics | 10/19/1999SE |
| K964872 | VZV Antigen Control SlidesGQW · Traditional | Viral Antigens, Inc. | 03/18/1997SE |
| K912239 | Vzvscan(Tm) Latex Aggutination TestGQW · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 06/11/1991SE |
| K903882 | Varicella-Zoster Virus Antibody Test Kit-Latex AggGQW · Traditional | Viral Antigens, Inc. | 12/04/1990SE |
| K894622 | Varicella Zoster VirusGQW · Traditional | Bion Ent., Ltd. | 10/24/1989SE |
| K843676 | Varicella/Zoster VirusGQW · Traditional | Institute Virion , Ltd. | 09/26/1985SE |
| K841434 | Varicella-Zoster(Igg) Ifa TestGQW · Traditional | Zeus Scientific, Inc. | 04/19/1985SE |
| K802938 | Varicella-Zoster Antigens & ControlsGQW · Traditional | Orion Diagnostica, Inc. | 12/31/1980SE |
Questions and answers
When was Viro Varicella-Zoster Virus Identification Reagent cleared by the FDA?
Viro Varicella-Zoster Virus Identification Reagent (K942743) received a 510(k) decision of Substantially Equivalent on December 15, 1994, 188 days after the submission was received.
What is the product code of K942743?
The FDA product code is GQW – Antigen, Cf, (Including Cf Control), Varicella-Zoster, a Class II (moderate risk) device regulated under 21 CFR 866.3900.