FDA 510(k)

BD Respiratory Viral Panel for BD MAX System; BD Respiratory Viral Panel-SCV2 for BD MAX System

K-Number: K230956 · 2023-07-31

ApplicantBd Integrated Diagnostic Solutions /

Decision Date2023-07-31

Product CodeQOF

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

BD Respiratory Viral Panel for BD MAX System; BD Respiratory Viral Panel-SCV2 for BD MAX System is a medical device manufactured by Bd Integrated Diagnostic Solutions /. It received FDA 510(k) clearance on 2023-07-31 under approval number K230956. The device is classified under product code QOF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BD Respiratory Viral Panel for BD MAX System; BD Respiratory Viral Panel-SCV2 for BD MAX System?

BD Respiratory Viral Panel for BD MAX System; BD Respiratory Viral Panel-SCV2 for BD MAX System is a medical device that received FDA 510(k) clearance on 2023-07-31. It is manufactured by Bd Integrated Diagnostic Solutions /. The 510(k) number is K230956.

When was BD Respiratory Viral Panel for BD MAX System; BD Respiratory Viral Panel-SCV2 for BD MAX System approved by the FDA?

BD Respiratory Viral Panel for BD MAX System; BD Respiratory Viral Panel-SCV2 for BD MAX System received FDA 510(k) clearance on 2023-07-31, under approval number K230956.

What company makes BD Respiratory Viral Panel for BD MAX System; BD Respiratory Viral Panel-SCV2 for BD MAX System?

BD Respiratory Viral Panel for BD MAX System; BD Respiratory Viral Panel-SCV2 for BD MAX System is manufactured by Bd Integrated Diagnostic Solutions /.

What is the FDA product code for BD Respiratory Viral Panel for BD MAX System; BD Respiratory Viral Panel-SCV2 for BD MAX System?

The FDA product code for BD Respiratory Viral Panel for BD MAX System; BD Respiratory Viral Panel-SCV2 for BD MAX System is QOF.

Related Clinical Trials

NCT05708755 CMV Immunity Monitoring in Lung Transplant Recipients RECRUITING NCT02389166 Optiflow in Sequential Non-Invasive Ventilation COMPLETED NCT07373496 Patient Position Monitoring System for Beam Gated Radiation Therapy of Malignancies of the Chest and Upper Abdomen RECRUITING NCT07063381 Low-frequency Electrical Stimulation for Cognitive Enhancement in Atrial Fibrillation ENROLLING_BY_INVITATION NCT00448981 Stopping Upper Respiratory Infections and Flu in the Family: The Stuffy Trial COMPLETED NCT06732050 Influence of Intraoperative Nociception Guided Analgesia on Perioperative Total Analgesic Requirement Endometriosis COMPLETED

Related PubMed Literature

PMID: 42173476 Feasibility of applying the Orthopaedic Data Evaluation Panel (ODEP) shoulder criteria for implants used in a United States-based integrated healthcare system. Journal of shoulder and elbow surgery (2026) PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026) PMID: 41054198 Relevant domains for health technology assessment of medical device reimbursement in Brazil's unified health system: a survey and Delphi panel study on stakeholder preferences. International journal of technology assessment in health care (2025)

Related Devices (Code: QOF)

DEN200031BioFire Respiratory Panel 2.1 (RP2.1)Biofire Diagnostics, LLC K231481Xpert Xpress CoV-2/Flu/RSV plusCepheid® K223591cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® SystemRoche Molecular Systems, Inc. K222736Panther Fusion SARS-CoV-2/Flu A/B/RSV AssayHologic, Inc. K230719BIOFIRE® SPOTFIRE® Respiratory (R) Panel MiniBiofire Diagnostics, LLC K220963Simplexa COVID-19 & Flu A/B DirectDiasorin Molecular, LLC

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.