Cepheid group b strep package insert

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August undefined, 2024

http://cepheid.mediaroom.com/2024-11-07-Cepheid-Receives-CE-Mark-for-Xpert-R-Xpress-GBS WebAbout Cepheid. Based in Sunnyvale, California, Cepheid is a leading molecular diagnostics company dedicated to improving healthcare by developing, manufacturing, and …

DEPARTMENT OF HEALTH & HUMAN SERVICES

WebNov 7, 2024 · Through its strong molecular biology capabilities, the company is focusing on those applications where accurate, rapid, and actionable test results are needed most, … WebMar 25, 2024 · About Cepheid Based in Sunnyvale, California, Cepheid is a leading molecular diagnostics company dedicated to improving healthcare by developing, … how much is school lunch in indiana

cobas® Strep A Assay - Diagnostics

WebThe QuickVue In-Line Strep A Test uses a unique in-line extraction to detect group A streptococcal antigen directly from patient throat swab specimens. Two-color results give clear readability and proven accuracy provides for dependable results. This is a true one-step test and is the first rapid strep A test waived under CLIA '88. WebJan 1, 2010 · The package insert indicates that the AccuProbe Group B Streptococcus Culture Identification Test exhibited a 97.7% sensitivity and a 99.1% specificity compared to standard culture and serologic or biochemical identification methods in a multisite study of women at 35 to 37 weeks' gestation. WebGroup B Streptococci (GBS), or S. agalactiae, is a Gram-positive bacterium that is commonly asymptomatic in adults. For newborns, however, it can lead to serious – even deadly – health issues including sepsis, … how much is school fees at wits university

Cepheid Package Inserts

WebThe Solana GBS Assay is an in vitro diagnostic test for the direct, qualitative detection of Group B Streptococcus from vaginal/rectal swabs following 18 to 24 hours incubation in LIM or Carrot broth cultures.. The assay utilizes … WebA real-time polymerase chain reaction (PCR) test for the detection of Strep A in throat swab specimens from patients with signs and symptoms of pharyngitis, cobas® Liat ® Strep A delivers labquality results in ~15 minutes. Help patients get the treatment and relief they need faster with the reliable accuracy of the cobas® Liat ® Strep A Test. 2 how do i find kaspersky on my computerWebXpert® Xpress Strep A is a qualitative real-time PCR test providing accurate detection of Group A Streptococcus in as soon as 18 minutes. Xpert® Xpress Strep A provides … how do i find linden home sims

"WebSolana, a simplified molecular testing platform, is making molecular diagnostics faster and easier than ever before, without sacrificing performance. Solana combines Quidel’s proprietary helicase-dependent amplification (HDA) with fluorescence detection to deliver results you can trust, in an actionable timeframe. " - Cepheid group b strep package insert

Cepheid group b strep package insert

CLIA Complexity: WAIVED - Roche Diagnostics

WebCepheid's Xpert ® GBS test is the only in vitro diagnostic test to fully meet CDC criteria for rapid intrapartum GBS testing. With results in less than an hour, Xpert GBS delivers … Web•Package Insert Barcode: on the Package Insert Barcode Card contained in this cobas®Strep A assay Tube Pack. This barcode is lot-specific; match the lot number next …

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WebTHE IMPACT Xpert MRSA NxG is an accurate, rapid, on-demand PCR test that provides actionable results in about an hour: Shift your lab from reactive to proactive • Rapidly identify MRSA colonized patients that require contact precautions to reduce the risk of transmission and avoid costly outbreaks • Improve overall patient safety by reducing the … http://cepheid.mediaroom.com/2024-11-16-Cepheid-Introduces-Xpert-GBS-LB-XC

WebPlease be aware that Cepheid does not take any responsibility for you accessing such information that may not comply with any legal process, regulation, registration or usage … http://cepheid.mediaroom.com/2024-11-16-Cepheid-Introduces-Xpert-GBS-LB-XC#:~:text=SUNNYVALE%2C%20Calif.%2C%20Nov.%2016%2C%202422%20%2F%20PRNewswire%20%2F,using%20enriched%20Lim%20broth%20cultures%20of%20patient%20samples.

WebNational Center for Biotechnology Information WebOpen the catalog to page 1. High-risk human papillomavirus (HPV) testing is a highly effective and reliable method of screening to prevent cervical cancer. An easy-to-use, rapid (~60 minutes to results), and scalable (1 to 80 tests per hour) HPV test with partial genotyping for the most important HPV types (HPV16 and HPV18/45) for risk ...

WebXpert® Xpress Strep A provides medically actionable and timely information to clinicians to support improved patient management and antibiotic stewardship For In Vitro Diagnostic Use More Information Xpert Xpress Strep A Test Package Insert SDS Professionals Also Viewed View Full Comparison No Image #931487 BD #441128 Reagent BD Viper™ …

WebCEPHEID JIM KELLY EXECUTIVE DIRECTOR, REGULATORY AFFAIRS 904 CARIBBEAN DRIVE SUNNYVALE CA 94089 Re: K172126 Trade/Device Name: Xpert … how do i find kohls near meWeb• To obtain accurate results, the Package Insert instructions must be followed. • Dispose of containers and unused contents in accordance with Federal, State, and Local regulatory requirements.... how do i find lifetime sales on ebayWebStrep A is responsible for over 600 million global cases of acute pharyngitis annually. 1 On a global scale, group A Streptococcus (GAS) is a leading cause of morbidity and mortality. 2 Clinical symptoms of GAS infection overlap with other diseases. how much is school lunch in alabama how do i find large files on windows 10WebAllows for the accurate detection of Group A Strep Gives you the confidence to make clinical decisions sooner Facilitates effective patient management Aids targeted antimicrobial therapy and Antimicrobial Stewardship Simple and Secure Results Reporting how much is school lunch in dickinson ndWebARIES®SARS-CoV-2 Assay Protocol File Kit CN-0499-01 An assay protocol file and a package insert, are provided on a USB. ForInVitroDiagnosticUse.ForEmergencyUseAuthorization(EUA)only. 2... how much is school lunch in georgiaWebThe Lyra Direct C. difficile Assay is a qualitative, multiplexed in vitro diagnostic test for the detection of toxin A gene ( tcdA) or toxin B gene ( tcdB) sequences of toxigenic strains of Clostridium difficile from unformed (liquid or soft) stool specimens collected from patients suspected of having Clostridium difficile -Associated Disease … how much is school lunch in iowa