The Siemens proprietary Complexed PSA is an alternative to traditional PSA testing for frontline detection. This new assay is defined as high sensitivity based on the criteria set forth by the International Federation of Clinical Chemistry (IFCC) Task Force on Clinical Applications of Cardiac Bio-Markers: Atellica ® IM Total . PDF 510(k) Substantial Equivalence Determination Decision ... Results obtained with different assay methods or kits cannot be used interchangeably. The Atellica IM TSH3-UL Assay is a third-generation assay that uses proven advanced chemiluminescent Acridinium Ester technology. Hemoglobin A1c (A1c_3) Calibrator Atellica CH - CAL 4 x 2 x 0.5mL. Use this form if there's a problem with the post - for example if you think a community guideline is being broken. GMDN Preferred Term Name GMDN Definition; Chemiluminescent immunoassay analyser IVD, automated A mains electricity (AC-powered) laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers (e.g., drug, hormone, microbial toxin) in a clinical specimen, using an immunological method that utilizes a chemiluminescent . Siemens Healthcare Diagnostics Inc. 511 Benedict Avenue, Tarrytown, NY 10591 USA . The Atellica IM COV2T assay is a fully automated 1‑step antigen sandwich immunoassay using acridinium ester chemiluminescent technology, in which antigens are bridged by antibodies present in the patient sample. Features. The Atellica® IM SARS-CoV-2 IgG (sCOVG) assay is a chemiluminescent immunoassay intended -quantitative detection of IgG antibodies to SARS -CoV-2 in human serum and plasma (lithium heparin) using . Atellica IM Fol DIL is stable onboard the system for 28 days. Atellica IM aTG - Sterilization. Chemiluminescent Immunoassay. The Atellica™ IM 1300 Analyzer (mid-volume) and the Atellica™ IM 1600 Analyzer (highvolume) have the same footprint and utilize the proven acridinium ester (AE) technology. You are about to report this post for review by an Inspire staff member. Results obtained with different assay methods or kits cannot be used interchangeably. It is a magnetic latex particle chemiluminescent immunoassay for the in-vitro quantitative determination of troponin I in serum and plasma samples. QTMD008.1 (Alinity 114 Abbott)- Điện hóa phát quang Roche Cobas 8000, ECLIA ElectroChemiluminescent Immunoassay, Roche Cobas 8000: QTMD008.3 (Roche cobas e801) 9. The Atellica® Solution is designed to address common clinical laboratory challenges. Device Count: 1. the new Siemens Atellica platform. Both assays target . Test Name. The COV2T test (Siemens Healthineers nr. chemiluminescent immunoassay: . Method comparison. Experience the power of the Atellica Solution! Device Description: Procalcitonin (PCT) Atellica IM - RGT 100T. GMDN Definition. Hepatitis C virus total antibody IVD, kit, chemiluminescent assay A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total antibodies to the Hepatitis C virus in a clinical specimen, using a chemiluminescent immunoassay method. Version or Model: 11099328. Both the Siemens Healthineers Atellica® IM* and the ADVIA Centaur®* SARS-CoV-2 IgG (sCOVG) assays measure IgG antibodies to SARS-CoV-2 in the blood to help clinicians assess the level of an individual's immune response over time. Reagent Atellica® IM Reproductive Endocrinology Assay Testosterone 2 For Atellica IM Analyzer 100 Tests 20 µL Sample Volume Siemens 10995708 Siemens Healthcare Laboratory Diagnostics offers laboratories fully automated immunoassay platforms and a comprehensive, disease-focused menu in excess of 100 tests. 1. PSA complexed with alpha-1-antichymotrypsin (ACT) comprises a higher proportion of PSA in men with prostate cancer 6-8 It is recommended as a frontline detection test It is used in conjunction with a digital rectal examination (DRE) Ascend Clinical Reference Ranges (May 2019) Tests Units Reference Ranges Methodology Instruments 0.89 - 1.76 Hypothyroid: < 0.89 Hyperthyroid: > 1.76 T4, Total (Thyroxine) ug/dL 4.5 - 10.9 Chemiluminescence Siemens Atellica IM-1600 The sensitivities and positive predictive values were 86.5 and 89.8 for Roche, 97.5 and 98.1 for Siemens, and 99.4 and 98.2 for Abbott, respectively. High-Sensitivity Troponin I. The most comprehensive information guide on Atellica IM aTG - SIEMENS HEALTHCARE DIAGNOSTICS INC including impacted physicians & ROI, Business Case, HEOR & VAC Business & Quality Metrics . Methodology: Siemens Atellica IM BR 27.29 (BR) chemiluminescent immunoassay was used. Introduction. Siemens Healthcare Diagnostics Inc. F. Proprietary and Established Names: Atellica IM High-Sensitivity Troponin I (TnIH) G. Regulatory Information: Product Code Classification Regulation Section Panel MMI Class II 21 CFR 862.1215 - Creatine phosphokinase/creatine kinase or isoenzymes test system Clinical Chemistry (75) Assay. Regulatory Information . The Atellica® Solution is designed to address common clinical laboratory challenges. Company Name: Siemens Healthcare Diagnostics Inc. It is a syndromic testing system for a variety of pathogens associated with key healthcare concerns. Immunoassay analyzer with chemiluminescence testing methodology using advanced acridinium ester technology. Device IDs: 00630414597300 ( Primary) 00630414211534 ( Unit of Use) Catalog Number: 11099328. One test produced a test result of 6.8 ng/mL and the other test produced a result of 5.8 ng/mL. For more details. The Atellica IM System instrument was previously cleared as the Trinidad IM instrument under k151792; the new name of the system is the Atellica IM Analyzer. The first 11206711, Munich, Germany) 16 is an automated 1-step antigen chemiluminescent sandwich immunoassay for total antibodies, and the COV2G (Siemens Healthineers nr. Trade Name . Introduction. E-mail: [email protected]. Laboratory Measurements. Both assays target the S1-RBD. 11206997) 17 is an automated 2-step chemiluminescent sandwich immunoassay for IgG antibodies against the SARS-CoV-2 virus. The Babson Diagnostics aC19G1 test is an indirect sandwich chemiluminescent immunoassay performed on the Atellica IM Analyzer intended for the qualitative detection of IgG antibodies to SARS-CoV-2 . Test principle The Atellica IM sCOVG assay is a fully automated 2‑step-sandwich immunoassay using acridinium-ester chemiluminescent technology. UNSPSC Code. 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