BD 256041 - IVeritor System Flu A & B Clinical Test Moderate Complexity Rapid Influenza Diagnostic Kit, 30 test/kt (Temp Sensitive; Non-Returnable) (Continental US Only)
The BD 256041 Veritor System Flu A & B Clinical Test (Moderate Complexity) is an advanced rapid diagnostic assay designed for the qualitative detection and differentiation of Influenza A and Influenza B viral antigens in respiratory specimens. Developed by BD (Becton Dickinson), this test is intended for use with the BD Veritor Plus Analyzer, providing objective digital results within approximately 10 minutes. It is CLIA moderate complexityclassified, offering a powerful combination of speed, accuracy, and convenience for clinical laboratories and healthcare facilities conducting influenza testing during flu season or in outbreak situations.
| Manufacturer | 256041 |
| Application | Respiratory Test Kit |
| CLIA Classification | CLIA Moderate Complexity |
| Reading Type | Machine Read |
| Reading Type | Machine Read |
| Test Name | Influenza A + B |
Key Benefits
The BD Veritor Flu A & B Test delivers highly accurate results quickly, enabling timely clinical decision-making and patient management. Its proprietary BD optical and digital reading technology minimizes user interpretation errors, providing clear and consistent results. The tests closed, self-contained design enhances biosafety by reducing exposure risk to potentially infectious material. With minimal hands-on time and automated interpretation, it supports efficient patient throughput in busy healthcare settings. Its integration with the BD Veritor Plus Analyzer also allows for secure data capture and easy connectivity with laboratory information systems (LIS).
Compatibility and Applications
This test is designed exclusively for use with the BD Veritor Plus Analyzer. It is suitable for use in hospitals, urgent care centers, clinics, physician offices, and moderate-complexity laboratories. The test is intended for nasal or nasopharyngeal swab specimens collected from individuals showing signs and symptoms of influenza. The BD 256041 Flu A & B test helps differentiate between influenza types A and B, supporting appropriate antiviral therapy decisions and infection control measures. It is particularly useful in pediatric, geriatric, and high-risk populations where timely diagnosis is critical.
Usage Guidelines
Collect the respiratory specimen using an approved swab and process it according to the manufacturers instructions. Insert the sample into the BD Veritor Flu A & B test device and incubate for the required period. After incubation, insert the device into the BD Veritor Plus Analyzer for automatic reading and interpretation. The analyzer will display clear Flu A Positive, Flu B Positive, or Negative results within minutes. Dispose of all used materials in accordance with local biohazard waste protocols. Always follow proper infection control and personal protective equipment (PPE) procedures when handling specimens.
Certifications, Safety Standards, and Regulatory Approvals
The BD 256041 Veritor Flu A & B Test is FDA-cleared for in vitro diagnostic (IVD) use and CLIA classified as a moderate complexity test. It is also CE-marked for global distribution. The test is manufactured under ISO 13485 and Good Manufacturing Practice (GMP) guidelines to ensure consistent quality and reliability. BDs rigorous validation processes guarantee compliance with performance standards for sensitivity, specificity, and reproducibility as outlined by regulatory and clinical authorities.
Comparison with Competitor Products
Compared to traditional lateral-flow influenza tests and manual interpretation kits, the BD Veritor Flu A & B Test offers enhanced accuracy through digital analysis. While manual tests can be subject to user variability and subjective interpretation, BDs Veritor Plus Analyzer provides objective, automated readings. The systems connectivity and data management capabilities also outperform most competing brands, allowing integration into electronic medical records (EMR) and improving workflow efficiency. The result is a faster, safer, and more reliable diagnostic process that reduces the likelihood of misdiagnosis.
Typical User Profile and Application Scenarios
This test is intended for healthcare professionals in clinical settings performing moderate complexity testing. It is ideal for laboratories, urgent care providers, pediatricians, and infection control teams who require quick and reliable influenza A/B differentiation. The BD Veritor Flu A & B Test is also used in occupational health centers, student health facilities, and long-term care environments to rapidly identify and contain flu outbreaks among vulnerable populations.
Best Practices for Use and Maintenance
Ensure that all operators are trained in both specimen collection and use of the BD Veritor Plus Analyzer. Store the test kits at 230C and avoid exposure to direct sunlight or moisture. Do not use test devices past their expiration date. Calibrate and maintain the BD Veritor Analyzer as recommended by the manufacturer to ensure continued accuracy. Always run positive and negative controls as part of routine quality assurance procedures, especially when opening new kit lots or analyzers.
Regulatory and Safety Information
This diagnostic product is intended for professional use in CLIA moderate complexity laboratories only. It is not designed for over-the-counter or at-home testing. Handle all specimens and materials as potentially infectious and dispose of them according to clinical biosafety guidelines. Refer to the products package insert and Safety Data Sheet (SDS) for complete information on test principles, limitations, and precautions. BD ensures that the Veritor Flu A & B Test meets all relevant global safety and performance requirements for clinical diagnostic testing.
How to Order
To purchase the BD 256041 Veritor System Flu A & B Clinical Test (Moderate Complexity), add the product to your cart and proceed through the secure checkout process on the CIA Medical website. For bulk orders, subscription supply, or institutional pricing, contact CIA Medical customer service at (312) 275-5850 or submit an inquiry via the contact form. CIA Medical provides fast delivery, competitive pricing, and expert support for all BD Veritor System and infectious disease diagnostic products.
