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FDA 510(k)

BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit

K-Number: K223016 · 2023-01-27

ApplicantBd
Decision Date2023-01-27
Product CodePSZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit is a medical device manufactured by Bd. It received FDA 510(k) clearance on 2023-01-27 under approval number K223016. The device is classified under product code PSZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit?

BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit is a medical device that received FDA 510(k) clearance on 2023-01-27. It is manufactured by Bd. The 510(k) number is K223016.

When was BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit approved by the FDA?

BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit received FDA 510(k) clearance on 2023-01-27, under approval number K223016.

What company makes BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit?

BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit is manufactured by Bd.

What is the FDA product code for BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit?

The FDA product code for BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit is PSZ.

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Related PubMed Literature

PMID: 42056377 Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh. Scientific reports (2026) PMID: 41529615 Wearable microneedle sensors for continuous interstitial fluid monitoring. Biosensors & bioelectronics (2026) PMID: 40706113 RNA aptamer-packaged virus-like particles for label-free, rapid, and on-site fluorescence detection of malachite green in aquatic products. Biosensors & bioelectronics (2025)

Other Devices by Bd

K180438BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit K221504BD Surgiphor™ Antimicrobial Irrigation System K232434BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived Kit K240257Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery Kit K253445BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120)

Related Devices (Code: PSZ)

K160164BD Veritor System for Rapid Detection of Flu A + B Labratory KitBecton, Dickinson & CO K160161BD Veritor System for Rapid Detection of Flu A + B CLIA waived kitBecton, Dickinson & CO K153012Sofia Influenza A+B FIAQuidel Corporation K173502Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab KitAlere Scarborough, Inc. K162438Sofia Influenza A+B FIA on Sofia 2Quidel Corporation K162642Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab KitAlere Scarborough, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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