Ct ng cepheid package insert

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August undefined, 2024

WebJan 3, 2024 · The Xpert CT/NG assay was the first nucleic acid-based test for CT and NG available for point-of-care (POC) use. Generally, this assay can be completed in 90 min, reducing the delay in reporting the results and potentially enabling rapid effective treatment. WebMay 29, 2024 · SUNNYVALE, Calif., May 29, 2024 / PRNewswire / -- Cepheid announced today that it has received U.S. Food and Drug Administration (FDA) 510 (k) clearance for testing throat and rectal specimens with its Xpert® CT/NG test. The test provides fast and accurate molecular detection of chlamydia and gonorrhea, making same-day …

Xpert CT/NG Cepheid

WebThe Cepheid® Xpert® CT/NG Vaginal/Endocervical Specimen Collection Kit is designed to collect, preserve and transport patient Chlamydia trachomatis and Neisseria … WebDescription. ZeptoMetrix external controls have demonstrated performance on a variety of molecular assays. The product has been tested with the Cepheid® GeneXpert® system … how fast does diflucan work on yeast

Chlamydia Trachomatis/Neisseria Gonorrhoeae Negative Control …

WebSep 29, 2024 · Cepheid's previously announced capacity expansion program, supported by parent company Danaher Corporation, was designed in part to address anticipated demand for Xpert Xpress SARS-CoV-2/Flu/RSV ... WebCT/NG Panel (17 X 1.2 mL) - Log in for Price. Add to Cart (800) 274-5487. Contact Us; Search keywords or SKU. Login (800) 274-5487. Products . Monkeypox Products; Coronavirus Products; ... The product has been tested with the Cepheid® GeneXpert® system and provides the expected results, however performance characteristics must be … WebTo change a limitation statement pertaining to pregnant women in the Cepheid Xpert CT/NG Assay package insert C. Measurand: Genomic DNA of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) D. Type of Test: Real Time Polymerase Chain Reaction E. Applicant: Cepheid F. Proprietary and Established Names: Xpert CT/NG high density carbs

Cepheid Package Inserts

WebIPC measurement is within the acceptable range. Where CT and/or NG DNA is detected, the IPC will be disregarded as the detection of the CT and/or NG DNA target will verify that the assay functions as expected. External controls are not provided with the assay. The package insert recommends a commercial source of external controls. WebThe Solution. Cepheid'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 91.9% sensitivity and 95.6% specificity. Not just a solution, a complete solution - Cepheid’s GeneXpert System, with Xpert ® GBS LB and Xpert GBS is ... how fast does dramamine workhttp://cepheid.mediaroom.com/2024-05-29-Cepheid-Receives-FDA-Clearance-for-Extragenital-Claims-for-Xpert-R-CT-NG-Test high density can liners

"WebConclusions: It was found that the Xpert CT/NG assay performed similarly to the Aptima transcription mediated amplification assay for the detection of CT and NG in extragenital specimens. The Xpert assay has the benefit of providing faster results at the point-of-care, thus reducing the turnaround time for results, potentially enabling same-day ... " - Ct ng cepheid package insert

Ct ng cepheid package insert

Cepheid Receives FDA Clearance for Extragenital Claims for Xpert® CT/NG ...

WebPackage Inserts Women’s health testing made simple. With just one sample, the Aptima Multitest Swab simplifies testing and provides more answers for sexual and vaginal health. Women's Health Assays With just one sample, the Aptima Multitest Swab simplifies testing and provides more answers for sexual and vaginal health. CT/NG Mycoplasma genitalium WebJun 1, 2024 · The Xpert CT/NG assay limit of detection was 88 to 161 EB/mL in rectal and 161 to 225 EB/mL in pharyngeal specimens by probit analysis (Cepheid package insert: Xpert CT/NG. Sunnyvale, CA).

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WebThe Abbott RealTi m e CT/NG assay is an in vitro polymerase chain reaction (PCR) assay for the direct, qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae. Abbott RealTime CT/NG Package Insert (PDF - 0.6 MB) For Information Only - Not a Controlled Copy VIEW ORDERING INFORMATION WebCepheid Package Inserts Package Insert Portal Select Language Document Title Document Number Date Xpert ® Xpress Nasopharyngeal Sample Collection Kit (Multi …

WebBD MAX CT/GC/TV is designed to detect the 3 most prevalent non-viral sexually transmitted infections—CT, GC and TV—in a single assay. With BD MAX CT/GC/TV you can provide quality patient care and support clinical decision accuracy and patient management. Download the BD MAX™ CT/GC/TV Info Sheet >> WebJun 27, 2024 · With Cepheid’s real-time PCR tests for CT/NG and TV: On-demand and in-visit results reduce patient call-backs, over treatment, under treatment and patients lost to follow-up Patient-collected specimens can provide operational efficiencies Same patient specimen can be utilized for Xpert CT/NG & Xpert TV

WebThe product has been tested with the Cepheid® GeneXpert® system and provides the expected results, however performance characteristics must be established by the end user. Formulated with purified, intact bacterial cells Bacterial cells are chemically modified to make them noninfectious Refrigerator stable—store between 2 and 8°C WebCepheid

WebXpert Urine Specimen Collection Kit. Manufacturer: Cepheid. Description. Disclaimers. Rx only. Designed to preserve and transport Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis DNA in first-catch female and male urine specimens from symptomatic and asymptomatic individuals prior to analysis with the Xpert CT/NG test …

WebDownload package insert documents for Aptima Combo 2 Assay for CT/NG. Skip to main content Safety Data; Package Inserts; Main navigation. Women's Health Products . Breast Health; Gynecological Health; Sexual Health; Body Composition ... Updated Version Package Insert for PRD-05576, PRD-05571, PRD-05572, and PRD-05572B. Part # … high density cartridge heaters manufacturersWeb16 X 100 mm, 8 mL Conventional / Yellow with No additive. 13 X 75 mm, 4 mL Conventional / Gray with Boric Acid, Sodium Formate a …. #481018. 133. BD #364943. Urine Specimen Collection Kit BD Vacutainer® 8 mL Plastic Collection Tube Sterile. BD Vacutainer® plastic collection kit for UA chemistry urine testing. high density carpetWebCarefully insert the swab into your vagina about two inches inside the opening of the vagina. Gently rotate the swab for 10-30 seconds. Ensure the swab touches the walls of the vagina so that moisture is absorbed onto the swab. Withdraw the swab and continue to … high density carpet foamWeb1. ®Read the package insert specific to the Cepheid Xpert CT/NG assay. 2. Tear open the foil pouch containing the quality control swab at the notch. 3. Remove the swab from the … high density cartridge heaters factoryWebFeb 13, 2024 · These tests analyze variations in the sequence, structure, or expression of deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) in order to diagnose disease or medical conditions, infection with... how fast does diflucan workWeb90-minute detection and differentiation of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) Product Resources MyCepheid Store VIDEO AIDS Health Foundation … Cepheid's Xpert ® GBS test is the only in vitro diagnostic test to fully meet CDC … high density cat3 patch panelsWebJun 27, 2024 · With Xpert ® CT/NG’s fast results in 90 minutes, same-day diagnosis and treatment are possible for fast and accurate patient care. Xpert TV is the first and only … high density carpet pad