VZV Antigen Control Slides
FDA 510(k) K964872 · Viral Antigens, Inc.
510(k) numberK964872
Submission
- Device name
- VZV Antigen Control Slides
- Applicant
- Viral Antigens, Inc.
Memphis, TN, US - Received
- December 5, 1996
- Decision date
- March 18, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| K942743 | Viro Varicella-Zoster Virus Identification ReagentGQW · Traditional | Viro Research, Inc. | 12/15/1994SE |
| 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 |
More from Orion Diagnostica, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K971101 | HSV-2 Antigen Control SlidesGQN · Traditional | 07/01/1997SE |
| K964874 | HSV-1 Antigen Control SlidesGQN · Traditional | 07/01/1997SE |
| K964875 | CMV Antigen Control SlidesGQH · Traditional | 03/18/1997SE |
| K964870 | RSV Antigen Control SlidesGQG · Traditional | 03/18/1997SE |
| K903882 | Varicella-Zoster Virus Antibody Test Kit-Latex AggGQW · Traditional | 12/04/1990SE |
Questions and answers
When was VZV Antigen Control Slides cleared by the FDA?
VZV Antigen Control Slides (K964872) received a 510(k) decision of Substantially Equivalent on March 18, 1997, 103 days after the submission was received.
What is the product code of K964872?
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.