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510(k) K133140

BD VERITOR SYSTEM FOR THE RAPID DETECTION OF RSV by Becton, Dickinson & CO — Product Code GQG

K133140 is an FDA 510(k) premarket notification submitted by Becton, Dickinson & CO for the device "BD VERITOR SYSTEM FOR THE RAPID DETECTION OF RSV". The FDA issued a decision of Substantially Equivalent on November 15, 2013. The device falls under product code GQG (Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus), a Class I device regulated under 21 CFR 866.3480. Becton, Dickinson & CO has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 2013
Date Received
October 17, 2013
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
Device Class
Class I
Regulation Number
866.3480
Review Panel
MI
Submission Type

Other clearances by Becton, Dickinson & CO

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  • K252040 — BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Bloo (March 13, 2026)
  • K250884 — 0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe (December 2, 2025)
  • K250358 — BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus fo (October 31, 2025)
  • K250059 — BD PhaSeal™ Optima Connecting Set (C83-O); BD PhaSeal™ Optima Spike Set (C180-O) (September 12, 2025)
  • K251713 — BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL) (August 8, 2025)
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Other clearances for product code GQG

  • K253318 — Clungene RSV Antigen Rapid Test (January 30, 2026)
  • K240280 — Nano-Check™ RSV Test (July 30, 2024)
  • K162911 — Sofia RSV FIA on Sofia 2 analyzer (February 22, 2017)
  • K132456 — BD VERITOR (TM) SYSTEM FOR RAPID DETECTION OF RSV (November 7, 2013)
  • K130398 — SOFIA(R) RSV FIA (August 13, 2013)
  • K121633 — BD VERITOR(TM) SYSTEM FOR THE RAPID DETECTION OF RSV (September 18, 2012)
  • K101918 — QUICKVUE RSV 10 (September 24, 2010)
  • K101514 — BD DIRECTIGEN EZ RSV (July 9, 2010)
  • K091235 — RAMP RSV ASSAY (July 24, 2009)
  • K070747 — QUICK VUE RSV TEST, MODELS 20193, 20199 (April 23, 2007)

FDA data resources