Sentences with phrase «ce mark»

Successful regulatory preparation and submission working with state Competent Authorities and Ethics Committees for approval to begin CE mark trials (Germany, Belgium, Czech Republic)
Assisted in the writing of the clinical dossier results from EU trial for submission to notified body for CE mark
Symetis is also developing the ACURATE neo / AS ** next generation valve system, currently in a clinical trial intended to serve as the basis for a future CE mark application.
Design is now complete, the company's now recruiting for human trials, and the main 2014/15 focus is on obtaining CE Mark approval & building up an EU sales team.
The Prosigna Assay has been CE - marked and is available for use by healthcare professionals in the European Union and other countries that recognize the CE Mark, as well as Canada, Israel, Australia, New Zealand and Hong Kong.
«The CE mark is recognised in most countries of the world, but it is much easier to gain than FDA approval in the US, so lots of US companies start in Europe to be on the market earlier,» says Wismer.
Just make sure that the shades you choose have the CE mark, as this guarantees they offer UV protection.
All plastic products bear the CE mark of the European Union.
Randgold CE Mark Bristow on Thursday told media in the country that the complex's all - Malian... →
We're in the final stages of the European regulatory process for the software and hope to have CE mark shortly.
We will follow with the CE mark on the VeriSeq NIPT product for distribution as an IVD solution early next year.
The year 2000 CE marks not merely the end of the second Christian millennium; it may well mark the end of Christianity as a clearly definable tradition.
SafeThe recently CE marked TM5 now incorporates the new ISO / TS 15066 guidelines on safety in collaborative robots systems, which covers four types of collaborative operation:
It does not have European CE marking and the U.S. Food and Drug Administration has not approved it for use in patients in the United States.
The team will apply for CE marking, a symbol shown on devices demonstrating that they conform with relevant EU medical devices directives, so that the implant can be used across hospitals outside of the clinical investigation, across Europe and beyond.
The new IVDD involves MP regulators in the CDx review process for CE marking.
is recognised by UK Fire and Rescue Services and the London Fire Brigade, suitable for installation to BS 7273 - 4 Standard Actuation (Category B) and conforms to EN1155 and is CE marked.
The closer is approved to EN1155, EN1154 and CE Marked, with additional features that include a seven segment LED display, manual release button and a low battery warning display.
Since then, TRIB's announced a CE Marking for its new point - of - care Uni-Gold Giardia test.
The highest level of attestation of conformity required for CE marking is 1 + and the lowest level of attestation is 4.
CE marking of construction products was introduced with the CPD in the 80s and the marking applied can consider only certain essential criteria.
Many manufactured goods require CE marking, which...
Issues included the incidence of VAT and whether or not the yacht, which was CE marked and MCA coded, had been properly constructed in accordance with the Recreational Craft Directive.
CES marked the coming - out party for AMD's latest processor, now named «Ryzen.»
Authored training modules for CE marking and ISO quality systems requirements.

Not exact matches

Marking his 13th Uncarrier promotion on Thursday at CES in Las Vegas, T - Mobile CEO John Legere also promised that for customers who sign up for the current unlimited plan, the company will never raise the price.
Per the publication, Mark Fields, Ford's CEO, will make the announcement at the impending Consumer Electronics Show (CES) in January 2016.
Early Christian Writings, earlychristianwritings.com / — a list of early Christian doc - uments to include the year of publication — 30 - 60 CE Passion Narrative 40 - 80 Lost Sayings Gospel Q 50 - 60 1 Thessalonians 50 - 60 Philippians 50 - 60 Galatians 50 - 60 1 Corinthians 50 - 60 2 Corinthians 50 - 60 Romans 50 - 60 Philemon 50 - 80 Colossians 50 - 90 Signs Gospel 50 - 95 Book of Hebrews 50 - 120 Didache 50 - 140 Gospel of Thomas 50 - 140 Oxyrhynchus 1224 Gospel 50 - 200 Sophia of Jesus Christ 65 - 80 Gospel of Mark 70 - 100 Epistle of James 70 - 120 Egerton Gospel 70 - 160 Gospel of Peter 70 - 160 Secret Mark 70 - 200 Fayyum Fragment 70 - 200 Testaments of the Twelve Patriarchs 73 - 200 Mara Bar Serapion 80 - 100 2 Thessalonians 80 - 100 Ephesians 80 - 100 Gospel of Matthew 80 - 110 1 Peter 80 - 120 Epistle of Barnabas 80 - 130 Gospel of Luke 80 - 130 Acts of the Apostles 80 - 140 1 Clement 80 - 150 Gospel of the Egyptians 80 - 150 Gospel of the Hebrews 80 - 250 Christian Sibyllines 90 - 95 Apocalypse of John 90 - 120 Gospel of John 90 - 120 1 John 90 - 120 2 John 90 - 120 3 John 90 - 120 Epistle of Jude 93 Flavius Josephus 100 - 150 1 Timothy 100 - 150 2 Timothy 100 - 150 T - itus 100 - 150 Apocalypse of Peter 100 - 150 Secret Book of James 100 - 150 Preaching of Peter 100 - 160 Gospel of the Ebionites 100 - 160 Gospel of the Nazoreans 100 - 160 Shepherd of Hermas 100 - 160 2 Peter 100 - 200 Odes of Solomon
30 - 60 CE Passion Narrative 40 - 80 Lost Sayings Gospel Q 50 - 60 1 Thessalonians 50 - 60 Philippians 50 - 60 Galatians 50 - 60 1 Corinthians 50 - 60 2 Corinthians 50 - 60 Romans 50 - 60 Philemon 50 - 80 Colossians 50 - 90 Signs Gospel 50 - 95 Book of Hebrews 50 - 120 Didache 50 - 140 Gospel of Thomas 50 - 140 Oxyrhynchus 1224 Gospel 50 - 200 Sophia of Jesus Christ 65 - 80 Gospel of Mark 70 - 100 Epistle of James 70 - 120 Egerton Gospel 70 - 160 Gospel of Peter 70 - 160 Secret Mark 70 - 200 Fayyum Fragment 70 - 200 Testaments of the Twelve Patriarchs 73 - 200 Mara Bar Serapion 80 - 100 2 Thessalonians 80 - 100 Ephesians 80 - 100 Gospel of Matthew 80 - 110 1 Peter 80 - 120 Epistle of Barnabas 80 - 130 Gospel of Luke 80 - 130 Acts of the Apostles 80 - 140 1 Clement 80 - 150 Gospel of the Egyptians 80 - 150 Gospel of the Hebrews 80 - 250 Christian Sibyllines 90 - 95 Apocalypse of John 90 - 120 Gospel of John 90 - 120 1 John 90 - 120 2 John 90 - 120 3 John 90 - 120 Epistle of Jude 93 Flavius Josephus 100 - 150 1 Timothy 100 - 150 2 Timothy 100 - 150 T - itus 100 - 150 Apocalypse of Peter 100 - 150 Secret Book of James 100 - 150 Preaching of Peter 100 - 160 Gospel of the Ebionites 100 - 160 Gospel of the Nazoreans 100 - 160 Shepherd of Hermas 100 - 160 2 Peter
Early Christian Writings, earlychristianwritings.com / — a list of early Christian doc - uments to include the year of publication — 30 - 60 CE Passion Narrative 40 - 80 Lost Sayings Gospel Q 50 - 60 1 Thessalonians 50 - 60 Philippians 50 - 60 Galatians 50 - 60 1 Corinthians 50 - 60 2 Corinthians 50 - 60 Romans 50 - 60 Philemon 50 - 80 Colossians 50 - 90 Signs Gospel 50 - 95 Book of Hebrews 50 - 120 Didache 50 - 140 Gospel of Thomas 50 - 140 Oxyrhynchus 1224 Gospel 50 - 200 Sophia of Jesus Christ 65 - 80 Gospel of Mark 70 - 100 Epistle of James 70 - 120 Egerton Gospel 70 - 160 Gospel of Peter 70 - 160 Secret Mark 70 - 200 Fayyum Fragment 70 - 200 Testaments of the Twelve Patriarchs 73 - 200 Mara Bar Serapion 80 - 100 2 Thessalonians 80 - 100 Ephesians 80 - 100 Gospel of Matthew 80 - 110 1 Peter 80 - 120 Epistle of Barnabas 80 - 130 Gospel of Luke 80 - 130 Acts of the Apostles 80 - 140 1 Clement 80 - 150 Gospel of the Egyptians 80 - 150 Gospel of the Hebrews 80 - 250 Christian Sibyllines 90 - 95 Apocalypse of John 90 - 120 Gospel of John 90 - 120 1 John 90 - 120 2 John 90 - 120 3 John 90 - 120 Epistle of Jude 93 Flavius Josephus 100 - 150 1 Timothy 100 - 150 2 Timothy 100 - 150 T - itus 100 - 150 Apocalypse of Peter 100 - 150 Secret Book of James 100 - 150 Preaching of Peter 100 - 160 Gospel of the Ebionites 100 - 160 Gospel of the Nazoreans 100 - 160 Shepherd of Hermas 100 - 160 2 Peter 3.
The earliest gospel — St. Mark's, written about 65 CE — begins with the baptism of an adult Jesus.
It is, then, with a certain confidence that he attempts the rather prodigious task of explaining the simultaneous engendering of intelligence and material bodies: ~ we are now, then, to attempt the genesis of intellect at the same time as the genesis of material bodies — two enterprises that are evidently correlative if it be true that the main lines of our intellect mark out the general form of our action on matter, and that the detail of matter is ruled by the requirements of our action» (CE 2040.
Even the most conservative dating still puts Mark, the earliest of the Gospels at 50 CE.
Today marked the end of CES.
For your peace of mind, all of our educational toys, games and nursery products carry the European CE safety mark.
Tech industry giants unveil their latest plans at the annual CES in Las Vegas, as upstart companies try to make their mark
The prospective, multi-center clinical performance evaluation study for CE - IVD marking was conducted at Curetis and three clinical centers in France and Germany.
Curetis N.V. (the «Company» and, together with Curetis USA Inc. and Curetis GmbH, «Curetis»), a developer of next - level molecular diagnostic solutions, today announced the successful completion of clinical performance evaluation and CE - IVD marking of its novel Unyvero Application Cartridge, UTI, for the diagnosis of severe urinary tract infections.
NIBSC provides a wide range of biological reference materials and reagents, including WHO international standards, influenza reagents, Quality Control Reagents Unit (QCRU) reagents and other CE - marked IVD reagents.
The included CE - marked LymphoTrack Dx bioinformatics software reliably identifies, separates, and analyzes data generated from any combination of samples and assays, so researchers and clinicians can sequence, analyze data files, and generate testing summaries within their own laboratories without uploading data to the Internet.
We provide a full - range of standardized CE - marked in vitro diagnostic products for hematology - oncology, as well as RUO assays, analyte specific reagents (ASRs), and DNA & RNA controls.
Invivoscribe provides ISO 13485 certified, PCR - and NGS - based reagents manufactured in a facility registered with FDA; RUO test kits; CE - marked IVDs, including IdentiClone ® and LymphoTrack ® Dx Assays with both LymphoTrack ® and LymphoTrack ® Dx Software; for clonality, MRD, and somatic hypermutation testing.
As a reagent manufacturer, we offer a comprehensive selection of gel, capillary, and next - generation sequencing PCR assays for gene rearrangement, chromosome translocation, and gene mutation detection as analyte specific reagents (United States), research use only, or CE - marked in vitro diagnostics to laboratories (outside of North America).
These include RUO and CE - marked IVD products that are used extensively all over the world.
Release of additional CE - IVD LymphoTrack ® Dx Assays, including an IGK clonality assay and assays targeting the IGH framework 2 and 3 regions, complements the previously released CE - marked assay that targets the IGH framework 1 region.
Invivoscribe will also seek CE IVD marking of a LymphoTrack TRB Assay for sale of kits to laboratories outside North America, and 510 (k) clearance in the United States.
«Our agreement with Thermo Fisher Scientific provides an opportunity to offer more than just RUO assays and CE - marked assays.
Reagents include RUO test kits and CE - marked IVDs, including IdentiClone ® and LymphoTrack ® Dx Assays with LymphoTrack ® Dx Software.
Unmatched performance — high transfection efficiency & cell viability in primary cells Fully scalable — from R&D to the clinic without reoptimization Safe — non-viral cell engineering in closed, sterile, computer - controlled environment Cell loading flexibility — mRNA, gRNA, siRNA, DNA, proteins, cell lysates, and small molecules into autologous or allogenic immune, stem / progenitor, or somatic cells Regulatory ease — Master File designation with the CBER Division of the U.S. FDA, cleared by NIH's RAC and Health Canada, cGMP - compliant, and CE - marked
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