Vidas Respiratory Syncytial Virus (RSV) Assay
FDA 510(k) K896097 · Vitek Systems, Inc.
510(k) numberK896097
Submission
- Device name
- Vidas Respiratory Syncytial Virus (RSV) Assay
- Applicant
- Vitek Systems, Inc.
Hazelwood, MI, US - Received
- October 20, 1989
- Decision date
- February 26, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GQG – Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3480
- Specialty
- Microbiology
Other 510(k)s with product code GQG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253318 | Clungene RSV Antigen Rapid TestGQG · Traditional | Hangzhou Clongene Biotech Co., Ltd. | 01/30/2026SE |
| K240280 | Nano-Check RSV TestGQG · Dual Track | Nano-Ditech Corporation | 07/30/2024SE |
| K162911 | Sofia RSV FIA on Sofia 2 analyzerGQG · Traditional | Quidel Corporation | 02/22/2017SE |
| K133140 | BD Veritor System for the Rapid Detection of RSVGQG · Special | Becton, Dickinson & CO | 11/15/2013SE |
| K132456 | BD Veritor (TM) System for Rapid Detection of RSVGQG · Traditional | Becton, Dickinson and Company | 11/07/2013SE |
| K130398 | Sofia(R) RSV FiaGQG · Traditional | Quidel Corp. | 08/13/2013SE |
| K121633 | BD Veritor(Tm) System for the Rapid Detection of RSVGQG · Traditional | Becton, Dickinson and Company | 09/18/2012SE |
| K101918 | Quickvue RSV 10GQG · Traditional | Quidel Corp. | 09/24/2010SE |
| K101514 | BD Directigen Ez RSVGQG · Traditional | Becton, Dickinson & CO | 07/09/2010SE |
| K091235 | Ramp RSV AssayGQG · Traditional | Response Biomedical Corp. | 07/24/2009SE |
More from Response Biomedical Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K920661 | Vidas CMV Igg AssayLFZ · Traditional | 02/12/1993SE |
| K921302 | Vitek Immunodiagnostic Assay SystemJHI · Traditional | 07/28/1992SE |
| K921176 | Vitek Immunodiagnostic Assay SystemCEP · Traditional | 04/08/1992SE |
| K920952 | Vitek Immunodiag Assay Syst(Vidas) Ferritine AssayDBF · Traditional | 04/07/1992SE |
| K915884 | Vidas Chlamydia Assay, ModificationLJC · Traditional | 03/04/1992SE |
| K905211 | Vidas Clostridium Difficile Toxin a (Cda) AssayLLH · Traditional | 10/11/1991SE |
| K912371 | Biomerieux RSV Direct If KitLKT · Traditional | 09/23/1991SE |
| K910230 | Lyme-Spot If KitLSR · Traditional | 08/30/1991SE |
| K910210 | Slidex Meningite-Kit 5GTJ · Traditional | 08/12/1991SE |
| K910304 | Rapid Coryne Syst/Identif of Coryneform BacteriaLQL · Traditional | 07/26/1991SE |
Questions and answers
When was Vidas Respiratory Syncytial Virus (RSV) Assay cleared by the FDA?
Vidas Respiratory Syncytial Virus (RSV) Assay (K896097) received a 510(k) decision of Substantially Equivalent on February 26, 1990, 129 days after the submission was received.
What is the product code of K896097?
The FDA product code is GQG – Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus, a Class I (low risk) device regulated under 21 CFR 866.3480.