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Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
FDA product code GQG · Class 1 · Microbiology
29
Registered devices
28
Adverse events
3
Recalls
32
510(k) clearances
Devices with this code
QuickVue — QUIDEL CORPORATIONBD Veritor™ System For Rapid Detection of RSV - Laboratory kit — BECTON, DICKINSON AND COMPANYBinaxNOW RSV — Alere Scarborough, Inc.FLU/RSV Positive Control — MERIDIAN BIOSCIENCE, INC.Easy Lab Pro RSV — AMERICAN BIO MEDICA CORPORATIONRed Tunica — Rodimedi & Associates, Inc.McKesson — MCKESSON MEDICAL-SURGICAL INC.IMAGEN Respiratory Syncytial Virus (RSV) — OXOID LIMITEDRapid Response — BTNX IncBinaxNOW RSV Control Swab Kit — Alere Scarborough, Inc.TRU RSV — MERIDIAN BIOSCIENCE, INC.RDS — AMERICAN BIO MEDICA CORPORATIONBinaxNOW RSV — Alere Scarborough, Inc.CLUNGENE — Hangzhou Clongene Biotech Co., Ltd.Rapid Response — BTNX IncMcKesson — MCKESSON MEDICAL-SURGICAL INC.BD Veritor™ System For Rapid Detection of RSV - CLIA waived kit — BECTON, DICKINSON AND COMPANYBinaxNOW Nasopharyngeal Swab Accessory Kit — Alere Scarborough, Inc.Nano-Check RSV Test — NANO-DITECH CORPORATIONBinaxNOW RSV — Alere Scarborough, Inc.QuickVue — QUIDEL CORPORATIONSofia — QUIDEL CORPORATIONCHORUS RESPIRATORY SYNCYTIAL VIRUS IgG — DIESSE DIAGNOSTICA SENESE SPARDS — AMERICAN BIO MEDICA CORPORATION
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2007-03-28 | Binax, Inc. dba IMPD | Tip of the foam swab could detach from the shaft causing injury to the patient. |
| 2004-02-18 | Binax, Inc. | Pouch integrity compromised |
| 2003-12-15 | Becton Dickinson & Co. | Diagnostic test kit may exhibit false positive results. |
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