The BD MAX™ System is a fully-integrated, automated platform that performs nucleic acid extraction, real-time PCR. The BD SARS-CoV-2 Reagents for BD MAX System is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR, in vitro diagnostic procedures, and use of the BD MAX System. Scroll through a list of Open-System Reagents available for use on the BD MAX System below. Surgical instruments These cookies are used in order to collect information regarding your browsing habits and profiling your center of interest with the aim of showing you advertisements and BD communications when they are relevant to your personal interests. Gastrointestinal care Infection prevention Introducing the BD MAX™ Vaginal Panel The BD MAX Vaginal Panel is the first FDA market-authorized, microbiome-based, polymerase chain reaction (PCR) assay that directly detects the 3 most common infectious causes of vaginitis: Bacterial vaginosis, vulvovaginal candidiasis a nd trichomoniasis. Patient monitoring and temperature management Vascular surgery SARS-CoV-2 Reagents for BD MAX™ System. The BD SARS-CoV-2 Reagents for BD MAX System results are for the identification of SARS-CoV-2 RNA. Biosciences 7. Testing is limited to U.S. laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C.§263a, to perform moderate and high complexity tests. Specimen collection Capability BD and the BD Logo are trademarks of Becton, Dickinson and Company. BD is experiencing elevated rates of potential false positive results from certain customers when using the BD SARS-CoV-2 Reagents for the BD MAX System. Drug delivery systems BD Biosciences provides flow cytometers, reagents, tools, and a wide range of services to support the work of researchers and clinicians who understand disease and improve care. The BD SARS-CoV-2 Reagents for BD MAX System utilizes multiplexed primers and probes targeting RNA from the nucleocapsid phosphoprotein gene (N1 and N2 regions) of the SARS-CoV-2 coronavirus, and the human RNase P gene. The BD MAX System uses a combination of lytic and extraction reagents to perform cell lysis, DNA extraction and removal of inhibitors. The BioGX Reagents offer laboratories a wide variety of syndromic groups from respiratory to sexual health, enteric pathogens, drug resistance, meningitis, transplant and tropical disease. 443419 - BD MAX™ StaphSR. Medication and supply management software, Medication and supply management technologies, Browse all medication and supply management products, Identification and susceptibility testing, Browse all microbiology solutions products, Patient monitoring and temperature management, Browse patient monitoring and temperature management, BD Recykleen sharps collectors and accessories, V Mueller and Snowden-Pencer open instrumentation, Healthcare-associated infection prevention, BioGX SARS-CoV-2 Reagents for BD MAX System. The primer and probe sets are based on the United States Centers for Disease Control and Prevention (US CDC) assay for specific detection of SARS-CoV-2 by amplifying two unique regions of the N gene (i.e., N1 and N2). Drainage Lab automation Microbiology solutions Following cell lysis, with a combination of heat and lytic enzymes, the released nucleic acids are captured by magnetic The BD SARS-CoV-2 Reagents for BD MAX™ System is a real-time RT-PCR test designed to detect SARS-CoV-2 in nasal, nasopharyngeal and oropharyngeal swabs samples from individuals suspected of COVID-19 by their healthcare provider 4; The assay utilizes multiplexed primers and probes targeting RNA from the nucleocapsid phosphoprotein gene (N1 and N2 regions) of the SARS-CoV-2 … We will review your submission and send additional information shortly. Meet the BD MAX™ The BD MAX™ System is a fully-integrated, automated platform that performs nucleic acid extraction and real-time PCR providing results for up to 24 samples across multiple syndromes in less than three hours*. Results across multiple syndromes. Urology and kidney health Browse the expanding catalog of BD products across a wide range of care areas, specialties and brands. All other trademarks are the property of their respective owners. Hazardous drug safety This product is manufactured and packaged as an Open System Reagent for the BD MAX™ system. The BD SARS-CoV-2 Reagents for BD MAX™ System is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasal, nasopharyngeal, and oropharyngeal swab samples from individuals suspected of COVID-19 by their healthcare provider. the left side of the BD MAX™ System and Rack B is on the right, Figure 2). Select Support Type The SARS-CoV-2 RNA is generally detectable in upper respiratory samples during the acute phase of infection. Support Sharps disposal solutions Drug delivery systems Home care Ref: 445003-01 Worldwide BD MAX System assay development partners and end-users are able to create User-Defined Protocols (UDPs) by leveraging these reagents to meet emerging diagnostic demands and address regional healthcare needs. 442967 - BD Viper™ LT System PCR Accessory Kit. The BioGX SARS-CoV-2 Reagents for BD MAX™ System is authorized for use on respiratory specimens from people who meet clinical and/or epidemiological criteria for Coronavirus Disease 2019 (COVID-19) testing. Molecular systems Respiratory care 9 Diabetes care © Hazardous drug safety These development partners and end-users have created UDP solutions for syndromes ranging from Respiratory to Tropical Disease. • The BD SARS-CoV-2 Reagents for BD MAX™ System can be used to test nasopharyngeal, nasal, mid-turbinate, and oropharyngeal swab specimens, nasopharyngeal wash/aspirate or nasal aspirates. The BD MAX™ System is cleared, approved, or market authorized by the FDA only when used with BD MAX IVD assays which have been cleared, approved, or market authorized by the FDA. Infusion therapy Medication and supply management Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities. Complete test in one tube Fully automated to simplify workflow Enter the barcode from each BD MAX™ Sample Preparation Reagent tube using the barcode scanner or manual entry. Wound care, Support Type SARS-CoV-2 Reagent + TNA-3 (COVID-19) – BD Max. The BD SARS-CoV-2 Reagents for BD MAX System is only for use under the Food and Drug Administration's Emergency Use Authorization. Cervical cancer screening Biosurgery Interventional specialities BD MAX ™ open system reagent suite Automate UDPs with easy-to-use open system reagents The objective of the BD MAX ™ open system reagent suite is to provide an easy-to-use, automated solution for labs performing user-defined protocols (UDPs), with the flexibility to respond to evolving needs. Hernia repair and fixation Syringes and needles BD offers an array of nucleic acid extraction and amplification reagents for use on the BD MAX System. Please select a Capability in order to start your service request. Vascular access The BioGX SARS-CoV-2 Reagents for BD MAX™ System is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal and oropharyngeal swab samples from individuals suspected of COVID-19 by their healthcare provider. document.write(new Date().getFullYear()) Medication and supply management Supply management Patient monitoring and temperature management The BD MAX ™ system offers you an efficient path to improved clinical outcomes by combining and automating extraction and thermocycling into a single platform capable of running both FDA-cleared and open system assays. Negative results must be combined with clinical observations, patient history, and epidemiological information. BD MAX ™ open system reagent suite Automate UDPs with easy-to-use open system reagents The objective of the BD MAX ™ open system reagent suite is to provide an easy-to-use, automated solution for labs performing user-defined protocols (UDPs), with the flexibility to respond to evolving needs. Capability Diabetes care The BioGX SARS-CoV-2 Reagents for BD MAX™ System is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the 2019-nCoV in nasopharyngeal and oropharyngeal swab samples from patients who meet COVID-19 clinical and/or epidemiological criteria. %' %' dqg wkh %' /rjr duh wudghpdunv ri %hfwrq 'lfnlqvrq dqg &rpsdq\ 2xu plvvlrq 0lwljdwlqj frvw suhvvxuhv 3urwhfwlqj sdwlhqwv dqg khdowkfduh zrunhuv,qfuhdvlqj Interventional specialities Prostate health COVID-19/Flu Combo Test for BD MAX™ Medication management NOTE: Items: #445003 & 442827, are now combined to the item 445003-01. Due to the excitation and emission characteristics of the acceptor dye, there will be … Flexibility and standardization allow you to … The agent detected may not be the definite cause of disease. Infusion therapy Our diverse resources give you the opportunity to obtain knowledge, gain insight and read success stories on our solutions. Biosurgery Visiting. Software solutions Start with Position 1 of Rack A and ensure that each patient/specimen ID and each BD MAX™ Sample Preparation Reagent tube is accurately matched. 443376 - BD MAX™ UVE Specimen Collection Kit. Thank You. 442963 - BD MAX™ Enteric Bacterial Panel. Worldwide BD MAX System assay development partners and end-users are able to create User-Defined Protocols (UDPs) by leveraging these reagents to meet emerging diagnostic demands and address regional healthcare needs. (C. jejuni and C. coli), and Shiga toxin 1 and 2 genes. Positive results do not rule out bacterial infection or co-infection with other viruses. Select Capability Sharps disposal solutions Lab automation Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. The BD MAX EBP kit comprises all the reagents and components needed for extraction and PCR set-up, including pipette tips. Biosciences BD MAX System is intended for in vitro diagnostic (IVD) use in performing FDA cleared or approved nucleic acid testing in clinical laboratories. BD offers an array of nucleic acid extraction and amplification reagents for use on the BD MAX System. Molecular diagnostics 24 tests BD MAX™ Enteric Bacterial Extraction Tube (B2) Oven-dried pellet containing DNA magnetic affinity beads, protease reagents and Sample Processing Control. BioGX SARS-CoV-2 Reagents for BD MAX™ System The test helps fill an urgent need across the U.S. for hospitals to access an easy-to-use, rapid diagnostic test to screen patients and health care workers for COVID-19. The BD SARS-CoV-2 Reagents for BD MAX™ System is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasal, nasopharyngeal, and oropharyngeal swab samples from individuals suspected of COVID-19 by their healthcare provider. BD MAX™ Enteric Bacterial Panel Reagent Strips Unitized Reagent Strip containing all the liquid reagents and disposable pipette tips necessary for DNA Extraction. 443420 - BD MAX™ UVE Sample Buffer Tubes 442969 - BD MAX™ CT/GC. The BD SARS-CoV-2 Reagents for BD Max System test is only authorized for use in laboratories in the United States certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform moderate and high complexity tests. Cervical cancer screening These cookies are used in order to collect information regarding your browsing habits and profiling your center of interest with the aim of showing you advertisements and BD communications when they are relevant to your personal interests. Billing Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. The BD MAX system helps redefine staff productivity with a fully integrated, automated molecular platform capable of running both FDA-cleared and open system assays efficiently and flexibly. Please Select, Capability Biopsy Infection prevention All rights reserved. 442970 - BD MAX™ CT/GC/TV. Software solutions BD Horizon Brilliant™ Violet 650 (BV650) (Ex-max 407 nm/Em-max 650 nm) is a tandem fluorochrome of BD Horizon BV421 and an acceptor dye with an Em Max at 650 nm. IVD assays, research use only (RUO) assays, and user-defined protocols (UDP) cannot be combined in the same rack. 442959 - BD ProbeTec™ Chlamydia trachomatis (CT) Qx Assay Gray Amp Reagent Pack. 6. Anesthesia delivery Specimen collection Clinical Reagents, Research Reagents, Single Cell Multiomics. Syringes and needles The BD SARS-CoV-2 Reagents for BD MAX™ System is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasal, nasopharyngeal, and oropharyngeal swab samples from individuals suspected of COVID-19 by their healthcare provider. Surgical instruments Single cell multiomics Kit components include: • Unitised reagent strips (24 strips for 24 tests) that allow a single strip to be used for a single test, thereby minimising waste and disposables. Hernia repair and fixation • The BioGX SARS-CoV-2 Reagents for BD MAX™ System can be used to test nasopharyngeal, nasal, mid-turbinate, and oropharyngeal swab specimens, nasopharyngeal wash/ aspirate or nasal aspirates. Clinical Reagents, Research Reagents, Single Cell Multiomics. Please Select The strip contains a single reaction tube, a BD. Shop a large selection of products and learn more about BD MAX Consumables: Microfluidic Cartridges Microfluidic Cartridges, 24 Microfluidic Cartridges, 24 Lane. Ordering False positive test results could lead to a delay in diagnosis and potentially cause the patient to be exposed to COVID-19 if they are isolated with an infected individual. Microbiology solutions Molecular diagnostics Anesthesia delivery Single cell multiomics Vascular access, Product Line It is the responsibility of the end user to determine the analytical performance of the reagents in an appropriately designed validation study. 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