• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Opinions
    • Top 30
    • Research
    • Supply Chain
    • Device Sectors
    • Directory
    • Events
    • Resources
    • Microsites
    • More
  • Magazine
  • News
  • Opinions
  • Top 30
  • Research
  • Supply Chain
  • Device Sectors
  • Directory
  • Events
  • Resources
  • Microsites
  • Current / Back Issues
    Features
    Editorial
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Reprints
    Subscribe Now
    Advertise Now
    Top Features
    Cybersecurity Challenges Leave Medical Device Makers Insecure

    OEMs Are Demanding Designs that Challenge Suppliers

    Diabetes Technology Manufacturers Seemingly on a Sugar Rush

    Post-Pandemic Partnerships: A Full-Service Outsourcing Discussion

    Discovering the Value of Surface Treatments and Coatings for Medtech
    OEM News
    Supplier News
    Service / Press Releases
    Online Exclusives
    Press Releases
    People in the News
    Product & Service Releases
    Supplier News
    Medtech Makers
    Technical Features
    International News
    Videos
    Product & Service Releases
    Live From Shows
    Regulatory
    Financial/Business
    Top News
    Medtronic, DaVita to Create New Kidney Care Firm

    OmniGuide's RevoLix HTL Hybrid Thulium Laser OK'ed for BPH and Stone Treatments

    In Vitro Diagnostic Medical Devices Regulation Takes Effect

    Brian Case Appointed Chief Technology Officer at KORU Medical

    Solid Growth Expected for India's Medical Device Sector
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Cybersecurity Challenges Leave Medical Device Makers Insecure

    OEMs Are Demanding Designs that Challenge Suppliers

    Diabetes Technology Manufacturers Seemingly on a Sugar Rush

    Post-Pandemic Partnerships: A Full-Service Outsourcing Discussion

    Discovering the Value of Surface Treatments and Coatings for Medtech
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Injecting Neurostimulators into Blood Vessels (We Swear, It’s Not Sci-Fi)

    Understanding the Costs of Care in the OR

    Sick of Being Sick: Pandemic Fatigue Flares at AAOS

    Managing Critical Healthcare Supply Chains in Turbulent Times

    To Drive Value, Human Capital Leaders Turn to Outsourced Solutions
    3D/Additive Manufacturing
    Contract Manufacturing
    Electronics
    Machining & Laser Processing
    Materials
    Molding
    Packaging & Sterilization
    R&D & Design
    Software & IT
    Testing
    Tubing & Extrusion
    Cardiovascular
    Diagnostics
    Digital Health
    Neurological
    Patient Monitoring
    Surgical
    Orthopedics
    All Companies
    Categories
    Company Capabilities
    Add New Company
    Outsourcing Directory
    Cirtec Medical

    BMP Medical

    Concise Engineering

    Trademark Plastics Inc.

    Fusion Biotec Inc.
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    3D Printing in Dental Prosthodontics, Orthodontics, and Surgery

    What New Tech Can Improve Your Medical Manufacturing Plant?

    Why Medical Device Firms Must Navigate the Muddy Waters of ESG Requirements

    Medical Device Servicing vs. Remanufacturing

    Digital Marketplaces for Medical Equipment Come of Age
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Cirtec Medical

    BMP Medical

    Concise Engineering

    Trademark Plastics Inc.

    Fusion Biotec Inc.
    • Magazine
      • Current/Back Issues
      • Features
      • Editorial
      • Columns
      • Digital Editions
      • Subscribe Now
      • Advertise Now
    • News
    • Directory
      • All Companies
      • ALL CATEGORIES
      • Industry Associations
      • Company Capabilities
      • Add Your Company
    • Supply Chain
      • 3D/Additive Manufacturing
      • Contract Manufacturing
      • Electronics
      • Machining & Laser Processing
      • Materials
      • Molding
      • Packaging & Sterilization
      • R&D & Design
      • Software & IT
      • Testing
      • Tubing & Extrusion
    • Device Sectors
      • Cardiovascular
      • Diagnostics
      • Digital Health
      • Neurological
      • Patient Monitoring
      • Surgical
      • Orthopedics
    • Top 30 Company Report
    • Expert Insights
    • Slideshows
    • Videos
    • eBook
    • Resources
    • Podcasts
    • Infographics
    • Whitepapers
    • Research
      • White Papers
      • Case Studies
      • Product Spec Sheets
      • Market Data
    • MPO Summit
    • Events
      • Industry Events
      • Live From Show Events
      • Webinars
    • Microsite
      • Companies
      • Product Releases
      • Product Spec Sheets
      • Services
      • White Papers / Tech Papers
      • Press Releases
      • Videos
      • Literature / Brochures
      • Case Studies
    • About Us
      • About Us
      • Contact Us
      • Advertise with Us
      • eNewsletter Archive
      • Privacy Policy
      • Terms of Use
    Breaking News

    Vela Diagnostics' SARS-CoV-2 RT-PCR Test v2.0 Earns EUA

    Automated test enables high throughput testing of up to 46 samples in a single run.

    Related CONTENT
    • Will Industry’s COVID-19 Recovery End Prematurely?
    • The Current COVID-19 Environment and Emergency Use Authorizations
    • OralDNA Labs Gains EUA for Saline Oral Rinse COVID-19 RT-PCR Test
    • BD's SARS-CoV-2 Antigen Test OKed in Europe
    • Saliva Tests Could Spot Silent COVID-19 Carriers
    PR Newswire09.24.20
    Vela Diagnostics announced the ViroKey SARS-CoV-2 RT-PCR Test v2.0 has obtained the Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). This automated probe-based reverse transcription PCR test detects SARS-CoV-2, the coronavirus responsible for COVID-19, in nasopharyngeal and oropharyngeal swabs. With the EUA, laboratories in the United States certified under the Clinical Laboratory Improvement Amendments will now be able to use the test for COVID-19 detection.
     
    "Receiving the EUA for our automated COVID-19 detection kit will enable us to better assist laboratory and healthcare personnel in managing the pandemic in the U.S.," said Sam Dajani, CEO and Chairman of the Board.  
     
    The ViroKey SARS-CoV-2 RT-PCR Test v2.0 is an automated probe-based reverse transcription PCR test optimized for a workflow consisting of Vela Diagnostics' Sentosa SX101 and the Sentosa SA201 instrument (or ABI 7500 Fast Dx). The automated test enables high throughput testing of up to 46 samples in a single run, with reduced hands-on time.
     
    Besides receiving EUA from the FDA, the ViroKey SARS-CoV-2 RT-PCR Test v2.0 has also received the CE mark and Provisional Authorisation from the Singapore Health Sciences Authority.
    Related Searches
    • Diagnostics
    Related Knowledge Center
    • Diagnostics
    Suggested For You
    Will Industry’s COVID-19 Recovery End Prematurely? Will Industry’s COVID-19 Recovery End Prematurely?
    The Current COVID-19 Environment and Emergency Use Authorizations The Current COVID-19 Environment and Emergency Use Authorizations
    OralDNA Labs Gains EUA for Saline Oral Rinse COVID-19 RT-PCR Test OralDNA Labs Gains EUA for Saline Oral Rinse COVID-19 RT-PCR Test
    BD BD's SARS-CoV-2 Antigen Test OKed in Europe
    Saliva Tests Could Spot Silent COVID-19 Carriers Saliva Tests Could Spot Silent COVID-19 Carriers
    Cepheid Cepheid's Combo COVID-19, Flu A/B, RSV Test Earns EUA
    Hologic Granted EUA for Asymptomatic COVID-19 Testing Hologic Granted EUA for Asymptomatic COVID-19 Testing
    TEAM Technologies Partners with Maxim Biomedical TEAM Technologies Partners with Maxim Biomedical
    FDA Authorizes First Point-of-Care COVID-19 Antibody Test FDA Authorizes First Point-of-Care COVID-19 Antibody Test
    Eurobio Scientific Launches Rapid Dx Test for SARS CoV-2 Virus Antigen Eurobio Scientific Launches Rapid Dx Test for SARS CoV-2 Virus Antigen
    COVID-19 Molecular Test Shipments Exceed 150 Million COVID-19 Molecular Test Shipments Exceed 150 Million
    Painless Paper Patch Glucose Level Test Uses Microneedles Painless Paper Patch Glucose Level Test Uses Microneedles
    Baxter, bioMérieux Ink Distribution Deal for Kidney Injury Dx Test Baxter, bioMérieux Ink Distribution Deal for Kidney Injury Dx Test
    FDA Approves Expanded Use of Roche FDA Approves Expanded Use of Roche's CINtec PLUS Cytology Test
    FDA Publishes COVID-19 Molecular Dx Test Comparative Performance Data FDA Publishes COVID-19 Molecular Dx Test Comparative Performance Data

    Related Content

    • Will Industry’s COVID-19 Recovery End Prematurely?

      Will Industry’s COVID-19 Recovery End Prematurely?

      Finally, a light at the end of the tunnel, but will it remain lit?
      Michael Barbella, Managing Editor 10.01.20

    • The Current COVID-19 Environment and Emergency Use Authorizations

      The Current COVID-19 Environment and Emergency Use Authorizations

      This column will provide information related to FDA EUAs granted due to the global COVID-19 pandemic.
      Christine Scifert and Dawn Norman, M.S., MRC-X LLC 10.01.20

    • Diagnostics
      OralDNA Labs Gains EUA for Saline Oral Rinse COVID-19 RT-PCR Test

      OralDNA Labs Gains EUA for Saline Oral Rinse COVID-19 RT-PCR Test

      First Emergency Use Authorization for a simple saline 30-second swish and gargle collection.
      PR Newswire 09.30.20


    • Diagnostics
      BD

      BD's SARS-CoV-2 Antigen Test OKed in Europe

      Portable, rapid PoC antigen test to detect SARS-CoV-2 in 15 minutes to be available in Europe by end of October.
      PR Newswire 09.30.20

    • Diagnostics
      Saliva Tests Could Spot Silent COVID-19 Carriers

      Saliva Tests Could Spot Silent COVID-19 Carriers

      Mass screening with self-collected saliva and rapid testing could provide easy, non-invasive, quick, relatively accurate results.
      Hokkaido University 09.29.20


      Trending
      • Dexcom Reportedly In Talks To Acquire Insulet | Medical Product Outsourcing
      • Shrinking Medical Devices Create Sizable Challenges For Micromolders | Medical Product Outsourcing
      • 5 Ways Plastics Revolutionized The Healthcare Industry | Medical Product Outsourcing
      • Anumana's ECG Pulmonary Hypertension AI Algorithm Gains Breakthrough Status | Medical Product Outsourcing
      • Prometheus Group Sued Over Reused Catheters And Rectal Sensors | Medical Product Outsourcing
      Breaking News
      • Medtronic, DaVita to Create New Kidney Care Firm
      • OmniGuide's RevoLix HTL Hybrid Thulium Laser OK'ed for BPH and Stone Treatments
      • In Vitro Diagnostic Medical Devices Regulation Takes Effect
      • Brian Case Appointed Chief Technology Officer at KORU Medical
      • Solid Growth Expected for India's Medical Device Sector
      View Breaking News >
      CURRENT ISSUE

      May 2022

      • Cybersecurity Challenges Leave Medical Device Makers Insecure
      • Contract Design for Medtech
      • Diabetes Medical Device Technology Update
      • Medtech Full-Service Outsourcing Q&A 2022

      Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
      You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

      • About Us
      • Privacy Policy
      • Terms And Conditions
      • Contact Us

      follow us

      Subscribe
      Nutraceuticals World

      Latest Breaking News From Nutraceuticals World

      Thorne Relaunches Gut Health Test with Microbiome Wipe
      Alkemist Labs Announces Alkemist Assured Seal and Next Generation Transparency Reports
      GC Rieber Foundations Expand Philanthropic Efforts
      Coatings World

      Latest Breaking News From Coatings World

      ICP Receives ASC Innovation Award for Spray Foam That Meets Changing Environmental Regulations
      Pylon Coatings Uses Polygiene Biomaster & Verimaster for Antimicrobial Surface Protection
      Sto Corp. Recognized with Multiple Honors at the EIFS Hero Awards
      Medical Product Outsourcing

      Latest Breaking News From Medical Product Outsourcing

      Medtronic, DaVita to Create New Kidney Care Firm
      OmniGuide's RevoLix HTL Hybrid Thulium Laser OK'ed for BPH and Stone Treatments
      In Vitro Diagnostic Medical Devices Regulation Takes Effect
      Contract Pharma

      Latest Breaking News From Contract Pharma

      DFE Pharma Opens India CoE for Fast-Track Formulation Services
      Helsinn Establishes New R&D Hub in the U.S.
      CureVac, myNEO Partner on Antigen Targets for mRNA-Cancer Vax Development
      Beauty Packaging

      Latest Breaking News From Beauty Packaging

      Carlyle To Acquire HCP Packaging
      Estée Lauder Companies Faces Class Action Lawsuit
      La Roche-Posay Launches Matte Moisturizer for Oily Skin
      Happi

      Latest Breaking News From Happi

      Women in Flavor and Fragrance Present 2022 Recognition Awards Dinner June 16
      Univar Expands Distribution Agreement with ANGUS Chemical Company
      Acme-Hardesty Passes Responsible Distribution Verification
      Ink World

      Latest Breaking News From Ink World

      NAPIM’s Virtual Digital & Emerging Technologies Conference is Back, June 14–15, 2022
      CEMATEX Introduces Online Business Platform to Connect Global Textile Community
      PICO Chemical Celebrates 46 Years
      Label & Narrow Web

      Latest Breaking News From Label & Narrow Web

      Teklynx software helps Top Clean Injection validate labels
      Zeller+Gmelin named Berry Global’s 2021 Ink Supplier of the Year
      Videojet and Loftware partner to accelerate labeling automation
      Nonwovens Industry

      Latest Breaking News From Nonwovens Industry

      Rael Raises $35M in Series B Funding
      Schobertechnologies Offers Rotary Web-fed Converting Solutions
      Thorne Relaunches Gut Health Test with Microbiome Wipe
      Orthopedic Design & Technology

      Latest Breaking News From Orthopedic Design & Technology

      ManaMed's ManaSport Wearable Ultrasound Earns FDA Nod
      Ekso Bionics Names Jerome Wong as Interim CFO
      Exactech Completes First Surgeries Using Next-Gen Cage Glenoid
      Printed Electronics Now

      Latest Breaking News From Printed Electronics Now

      ams OSRAM Introduces New Horticulture LEDs
      Avery Dennison Launches AD Twist U7XM Inlays
      ARPA-E Funding Drives Innovation, Industry Partnerships at NREL

      Copyright © 2022 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

      AD BLOCKER DETECTED

      Our website is made possible by displaying online advertisements to our visitors.
      Please consider supporting us by disabling your ad blocker.


      FREE SUBSCRIPTION Already a subscriber? Login