This is a prospective evaluation of the diagnostic performance of the Abbott RT-MTB and its RT-MTB RIF/INH assays. The key to full recovery is often a fast, accurate diagnosis. Helping people get and stay healthy with quality medicines you can trust. Our diagnostic solutions are used in hospitals, laboratories and clinics around the globe. VIEW THE M2000. 0g8XN< (:1+it00]e`|n,_d8Hh"PH ?\p A 14-year-old boy died Thursday night after falling from a ride at an Orlando amusement park that takes passengers 430 feet in the air before plummeting toward the ground at 70 miles per hour . Abbott mSample Preparation System DNA (1) Abbott mSample Preparation System RNA Bulk Lysis Buffer Kit (1) GMDN Term. Content is not under the control of corelaboratory.abbott. DNA in plasma. Nucleic acid was extracted from plasma (400 l) with the Abbott mSample Preparation System DNA kit (Abbott Molecular, Des Plaines, IL, USA) on the Abbott m2000sp platform (Abbott Molecular),. PQDx 0084-027-00 WHO Public Report December 2019, version 3.0 Page 1 of 36 . The Abbott RealTime CMV/EBV maxCycle protocol was used for this study: it al-lowed the management of CMV and EBV samples in a single run but required a specic extraction for each test, in two dierent tubes, when both of these parameters were requested at the same time. Manufacturer orAuthorized Representative: Abbott Germany. EA#o! Some types may include controls for the subsequent nucleic acid technique (NAT) analysis. $288.00. Thermo Scientific Pharma KingFisher Flex Magnetic Particle Processor. Abbott mSample Preparation System DNA: 2: In Commercial Distribution: 06K12-24: 00849811004452: GS1: 1: 089855696: NA: Abbott mSample Preparation System DNA is a nucleic acid extraction system used for laboratory isolation of DNA from biological samples. Summary Background and aim: Quantification of cytomegalovirus (CMV) DNAemia is essential in clinical management of post-transplant infec-tion. Results were standardized to international units per . The Alinity, ARCHITECT, ACCELERATOR and CELL-DYN systems are intended for performing in vitro diagnostic assays on samples of human origin (blood, urine). DNA extractions were performed from 500 L of plasma using an Abbott mSample preparation system DNA kit on an m2000sp instrument (Abbott Molecular, Illinois, USA) and eluted in a volume of 70 L. Some types may include controls for the subsequent nucleic acid technique (NAT) analysis. ZERO BIAS - scores, article reviews, protocol conditions and more No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company. Study design and setting. A collection of reagents and other associated materials intended to be used for the extraction and/or isolation of nucleic acid from clinical specimens and/or biological cultures in preparation for subsequent analysis using a nucleic acid-based method. We compared the performance characteristics of the Abbott mSample preparation system DNA kit on the m24 SP instrument (Abbott), the High Pure viral nucleic acid kit on the COBAS AmpliPrep system (Roche), and the EZ1 Virus 2.0 kit on the BioRobot EZ1 extraction platform (Qiagen) coupled with the abbott msample preparation system dbs buffer kit ( 1) abbott msample preparation system dna ( 1). Max. Medical Devices companies use Gridlex Zip Help Desk, Customer Services, Shared Mailbox and Ticketing system to manage Medical Device customer support, quality, safety, complaints and ordering, and other operations, Abbott mSample Preparation System DBS Buffer Kit, Hospital Reimbursement & Quality Outcomes, PROMEGA CORPORATION - Abbott mSample Preparation System DBS Buffer Kit : Product Information, PROMEGA CORPORATION - Abbott mSample Preparation System DBS Buffer Kit : Product Code Information, Labeling does not contain MRI Safety Information, Nucleic acid extraction/isolation kit IVD. The nucleic acids are then ready for amplification. Download scientific diagram | Bland-Altman representation of CMV DNA loads (copies/ ml) measured using the Abbott CMV PCR kit in the m2000RT (ABBOTT) after extraction by the Abbott mSample . the following automated nucleic acid extraction methods were evaluated: the abbott msample preparation system dna kit on the m24 sp instrument (abbott diagnostics, il), the high pure viral nucleic acid kit on the cobas ampliprep system (roche diagnostics, mannheim, germany), and the ez1 virus 2.0 kit (qiagen, valencia, ca) on the biorobot ez1 The website that you have requested also may not be optimised for your screen size. me HIV-1 Quali Abbott Laboratories abbott msample preparation system dna Abbott Msample Preparation System Dna, supplied by Abbott Laboratories, used in various techniques. This website contains general information about our products sold worldwide. This study aimed to validate an in-house quantitative real-time PCR assay targeting the BKPyV major capsid VP1 gene for assessment of viral load using the Abbott m2000 RealTime System. Nucleic acid extraction/isolation kit IVD (4) FDA Product Code Name. WHO Prequalification of Diagnostics Programme . GMDN Names and Definitions: Copyright GMDN Agency 2015. hA 04r\GczC. Device Description: Abbott mSample Preparation System DNA is a nucleic acid extraction system used for laboratory isolation of DNA from biological samples. 2022 Abbott, Abbott Park, Illinois, U.S.A. m2000 system: m2000sp instrument (optional for automated, medium throughput sample processing, 145.0 79.4 217.5 cm, weight 314.4 kg), m24sp instrument (optional for automated, However, the chemistry provided in the specialized DNeasy Mericon Food Kit resulted in the best results from poorly digested material. The ex- Abbott mSample Preparation System DNA, Pack/96 (4x24 Extractions) Indicative Price 248.50 USD. The complete sample DNA and RNA extraction and 96-well preparation for qPCR analysis is achieved in less than three hours using PrepSEQ . Discover how the use of troponin in the asymptomatic population can help to accurately identify the risk of a future cardiac event. Brand Name: Abbott mSample Preparation System DNA. WHO Prequalification of Diagnostics Programme . Bioz Stars score: 86/100, based on 3 PubMed citations. Device Name: Abbott mSample Preparation System is a nucleic acid extraction system used for laboratory isolation of RNA from biological samples.. Company Name: PROMEGA CORPORATION. Abbott mSample Preparation System DBS Buffer Kit - GMDN. In contrast, the Abbott magnetic beads system resulted in the highest DNA yields from . formed using the Abbott mSample Preparation System DNA. Abbott Laboratoriesabbott msample preparation system dna Abbott Msample Preparation System Dna, supplied by Abbott Laboratories, used in various techniques. Abbott mSample Preparation System DBS Buffer Kit: 2: To capture DNA from the studied samples, an Abbott mSample Preparation System DNA kit (CE-IVD), which is based on magnetic microparticles, was used. Non-methylated cytosine residues are converted into uracil Version (Model) Number: 04J70-24. Home / Medical devices / Abbott mSample Preparation System DNA. Product Attributes Guide. Automation system along with one of the largest infectious disease assay menus that creates efficiency and reliability from bar-coded laboratory tubes through patient results. Explore articles from the Economist Intelligence Unit to discover how recent innovations driven by clinical diagnostics can help advance patient care. ABBOTT REALTIME HBV ASSAY/ CALIBRATOR KIT/CONTROL KIT & ABBOTT MSAMPLE PREPARATION SYSTEM DNA: Generic Name: hepatitis viral b dna detection: Applicant: ABBOTT MOLECULAR, INC. 1300 east touhy avenue des plaines, IL 60018: PMA Number: P080026: Supplement Number: S019: Date Received: 11/16/2016: Decision Date: 12/13/2016: Product Code: The Abbott mSample Preparation SystemDNA uses magnetic particle technology to capture nucleic acids and washes the particles to remove unbound sample components. me HIV-1 Qual Global Unique Device ID: 00849811004452. we compared the performance characteristics of the abbott msample preparation system dna kit on the m24 sp instrument (abbott), the high pure viral nucleic acid kit on the cobas ampliprep system. Amplification and real-time detection of CMV DNA was performed on an m2000rt instrument. Abbott mSample Preparation System DNA. Items are stocked in the UNICEF Supply Division warehouses. Reliability of assay results cannot be guaranteed if there are any deviations from the instructions in this package insert.Key to symbols used List Number In Vitro Diagnostic Medical Device. Isolates total genomic DNA from a wide range of specimens including cells, bacteria, yeast, plants, tissue, FFPE, soil, saliva, urine, blood and many more Available in spin column format, 96 well plates, and magnetic beads Efficiently extract inhibitor-free total genomic DNA Abbott mSample Preparation System DNA. Nucleic acid extraction/isolation kit IVD, 00849811051739 - Maxwell CSC RNA Blood Kit, 00849811051746 - Maxwell CSC RNA FFPE Kit, 00849811051753 - Maxwell CSC DNA FFPE Kit, 00849811051777 - Maxwell CSC Blood DNA Kit, 00849811060960 - Maxwell CSC Viral Total Nucleic Acid Purification Kit, 00849811060991 - Maxwell CSC 48 Instrument, 00849811064647 - Maxwell CSC Whole Blood DNA Kit, Labeling does not contain MRI Safety Information, Between 15 Degrees Celsius and 30 Degrees Celsius, 2022-02-09 The Maxwell CSC Instrument is a nucleic acid extraction instrument used in combination with Maxwell CSC reagent kits to perf, 2022-02-09 The Maxwell CSC RNA Blood Kit is a reagent kit used in combination with Maxwell CSC instruments to perform automated isolati, 2022-02-09 The Maxwell CSC RNA FFPE kit is a reagent kit used in combination with Maxwell CSC instruments to perform automated isolatio, 2022-02-09 The Maxwell CSC DNA FFPE Kit is a reagent kit used in combination with Maxwell CSC instruments to perform automated isolatio, 2022-02-09 The Maxwell CSC Blood DNA kit is a reagent kit used in combination with Maxwell CSC instruments to perform automated isolati, 2022-02-09 The Maxwell CSC Viral Total Nucleic Acid Purification DNA kit is a reagent kit used in combination with Maxwell CSC instrume, 2022-02-09 The Maxwell CSC 48 Instrument is a nucleic acid extraction instrument used in combination with Maxwell CSC reagent kits to p. As a result, the site may contain information on pharmaceuticals, medical devices and other products or uses of those products that are not approved in other countries or regions. PROMEGA CORPORATION ABBOTT MSAMPLE PREPARATION SYSTEM DNA CLINICAL SAMPLE CONCENTRATOR: Back to Search Results: Catalog Number 06K12-24: Device Problem False Positive Result (1227) Patient Problem No Clinical Signs, Symptoms or Conditions (4582) Event Date 09/18/2020: Event Type malfunction Manufacturer Narrative . DNA from all the samples was extracted from 500 L of plasma and eluted in a volume of 70 L (Abbott mSample preparation system DNA kit on the m2000sp instrument). Abbott mSample Preparation System DNA (00849811004452), Labeling does not contain MRI Safety Information, Nucleic acid extraction/isolation kit IVD. Our diagnostic solutions are used in hospitals, laboratories and clinics around the globe. Reproduced with Permission from the GMDN Agency. The crucial information derived from our tests, instruments and informatics systems are often the first step in patient care decision making for hundreds of health conditions from heart attacks . For information regarding lithium batteries in Abbott equipment, please email battery@chemtrec.com or call +1-571-444-1844. Are you a Medical Device Company? Clinical Sample Concentrator (2) General Purpose Reagent (2) The nucleic acid bound to microparticles is then eluted. International: Call your Abbott Representative This package insert must be read carefully before product use.Package insert instructions must be followed. For product availability in your country, please contact your local Abbott representative. We evaluated the performances of two quantitative real-time Abbott mSample Prep System DNA, pack/96 | Africa Medical Supplies Platform. Device Name: Abbott mSample Preparation System DNA is a nucleic acid extraction system used for laboratory isolation of DNA from biological samples.. Company Name: PROMEGA CORPORATION. Product: Abbott RealTi. The study was conducted in the district of Manhia . Both assays were performed on the same DNA extract obtained from thawed plasma samples within 48 h of DNA extraction. Abbott m Sample Prep System DNA, pack/96. Abbott's commitment to drive excellence in clinical chemistry is seen through sigma Strong, helping laboratories achieve measurably better healthcare performance. 2 The Abbott mSample Preparation SystemDNA uses magnetic particle technology to capture nucleic acids and washes the particles to remove unbound sample components. PUBLIC REPORT . We offer a high throughput solution for the automation of the PrepSEQ workflow to purify samples for residual host cell DNA analysis. Version (Model) Number: 06K12-24. AlinIQ Always On Services can help you achieve operational efficiency and increased productivity by avoiding unexpected downtime. Driven by collaboration with laboratories and organizations around the world, Abbott is committed to helping proactively evaluate and solve some of the toughest infectious disease challenges. device: Medical device code: 06DV5252117791 Form date: 01/12/2016 15:54 Record date MD: 06/12/2016 14:01 Date introduce requestor in the system: 01/12/2014 11:47 Identification of the manufacturer: Manufacturer name, long: Abbott . Some types may include controls for . . The key to full recovery is often a fast, accurate diagnosis. Abbott Molecular Inc. is the legal manufacturer of the Abbott multi-Collect Specimen Collection Kit Promega Corporation is the legal manufacturer of the Abbott mSample Preparation System DNA. PROMEGA CORPORATION FDA.report GUDID PROMEGA CORPORATION 00849811004452 Nucleic acid extraction/isolation kit IVD Customer Support Contacts Operating and Storage Conditions Storage Environment Temperature we compared the performance characteristics of the abbott msample preparation system dna kit on the m24 sp instrument (abbott), the high pure viral nucleic acid kit on the cobas ampliprep system (roche), and the ez1 virus 2.0 kit on the biorobot ez1 extraction platform (qiagen) coupled with the abbott cmv pcr kit, the lightcycler cmv quant kit Abbott mSample Preparation System DNA is a nucleic acid extraction system used for laboratory isolation of DNA from biological samples. PUBLIC REPORT . M2000 REALTIME SYSTEM and assays. 4/ 93) l- 2 system operating manual identiiies a variety of potential malfunctions within the device, cassette, and interface. value paid with public resources: Processing Data for med. device: Medical device code: 06DB5252150883 Identity type: GTIN Identity: GTIN Form date: 30/05/2019 11:33 Record date MD: 30/05/2019 14:50 Date introduce requestor in the system : 09/05/2018 12:27 Identification of the manufacturer: Manufacturer name, long: Abbott Molecular Inc. Code type . A collection of reagents and other associated materials intended to be used for the extraction and/or isolation of nucleic acid from clinical specimens and/or biological cultures in preparation for subsequent analysis using a nucleic acid-based method. Abbott is providing these links to you only as a convenience, and the inclusion of any link does not imply endorsement of the linked site by Abbott. For over 50 years Abbott has been committed to delivering innovative immunoassays to serve the hepatitis diagnostics community. Other reagents: Abbott mSample Preparation System DNA Kit (192 sample preparations/kit) and inactivation reagent (IR). The following icons may appear on the product page and product details page of the catalogue for better understanding of the attributes of our supplies. ZERO BIAS - scores, article reviews, protocol conditions and more Bioz Stars score: 86/100, based on 1 PubMed citations. CLOSE Device Characteristics Device Record Status Alternative and Additional Identifiers Customer Contact [?] Max. All ARCHITECT analyzers, Alinity hq, CELL-DYN Ruby, CELL-DYN Sapphire and CELL-DYN Emerald 22 AL instruments are Class I laser products. Content is intended for healthcare professionals only. Cold Chain temperature requirements: Constant temperature between +2 to +8C (36 to 46F) at all levels . ACCELERATOR APS and ACCELERATOR a3600 are Class II laser products. Global Unique Device ID: 00849811004445. value paid with public resources: Processing Data for med. endstream endobj 2422 0 obj <>/Filter/FlateDecode/Index[98 2285]/Length 67/Size 2383/Type/XRef/W[1 1 1]>>stream The bound nucleic acids are eluted and transferred to a 96 deep-well plate. The bound nucleic acids are eluted. In the rst stage, DNA is captured and puried in magnetic eld. Premarket Submission Number Not Available/Not Released, Storage Environment Temperature: between 15 and 30 Degrees Celsius. Add to cart. Certain products described or certain features of some products described on this global page might not be commercially available in your country. 01/ 06) system operating manual for use with list. the id now covid- 19 rapid point- of- care test. Product availability varies by country. Description. The crucial information derived from our tests, instruments and informatics systems are often the first step in patient care decision making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers. Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. PQDx 0084-027-00 WHO Public Report November 2021, version 4 .0 Page 1 of 36 . Product: Abbott RealTi. Discover how you can achieve measurably better healthcare performance with our personalized solutions: Follow the Abbott | Diagnostics LinkedIn channel for the latest news from our company and within the in vitro diagnostics industry. Please be aware that the website you have requested is intended for the residents of a particular country or countries, as noted on that site. The information and recommendations contained herein are based upon tests believed to be reliable. Brand Name: Abbott mSample Preparation System. Links which take you out of Abbott worldwide websites are not under the control of Abbott, and Abbott is not responsible for the contents of any such site or any further links from such site. The Alinity ci-series offers powerful integration across clinical chemistry and immunoassay systems helping laboratories maximize their operational efficiency. Abbott mSample Prep System DNA, pack/96. The Abbott mSample Preparation System DNA as well as the Qiagen DNA Mini Kit and DNeasy Mericon Food Kit resulted in successful preparation results from all materials. Read the instructions in the system manuals and labeling and/or reagent instructions carefully. 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