decision diagnostics corp fda approval
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SEC Complaint: Keith Berman and Decision Diagnostics Corp
17 déc 2020 · Statements Berman and DECN made about FDA emergency use authorization were material to the market including to investors and potential |
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Decision Diagnostics Corp
29 jan 2024 · DECN made misleading and inaccurate statements related to the status of its application for FDA approval of its test kits On April 6 2020 |
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SEC Complaint: Keith Berman and Decision Diagnostics Corp.
17 déc. 2020 DECN filed an application with the FDA for emergency use authorization for a. Covid-19 testing kit (the “EUA Application”) on April 3 2020. On ... |
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Amended Petition for Termination of Trading
7 mai 2020 Decision Diagnostics Corp. (hereinafter “DECN” or the “Company”) |
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UNITED STATES OF AMERICA Before the SECURITIES AND
20 mai 2020 Counsel for Decision Diagnostics Corp. /s/ David Misler. David Misler ... Misleading Statements Concerning FDA Approval. |
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CEO of Medical Device Company Charged in COVID-19 Related
15 déc. 2020 Decision Diagnostics Corp. ... FDA approval so we can raise money." ... BERMAN was therefore aware that FDA approval was not. |
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List of SARS-CoV-2 Diagnostic test kits and equipments eligible for
il y a 6 jours The decisions taken based on the Canada's Minister of Health interim ... The COVID-19 diagnostic tests approved by the Ministry of Health ... |
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Principles for Codevelopment of an In Vitro Companion Diagnostic
15 juil. 2016 an IVD companion diagnostic should be approved granted a de novo request or cleared by. 125. FDA contemporaneously with the approval of the ... |
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Guidance for Industry and FDA Staff In Vitro Diagnostic (IVD) Device
25 juin 2010 Appendix 1: REGULATORY DECISION TREE (21 CFR PART 812) for IVD. INVESTIGATIONAL STUDIES. ... Part 814 Premarket Approval of Medical Devices. |
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PERSONALIZED MEDICINE AT FDA
which focuses on using biomarkers as the basis for treatment decisions as rapidly approves diagnostic tools and treatments that expand the field. |
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ROCHE DIAGNOSTICS CORPORATION v. MESO SCALE
8 avr. 2022 Roche Diagnostics Corporation and BioVeris Corpora- ... for FDA approval (ii) it is declared developed by the Board. |
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PERSONALIZED MEDICINE AT FDA
Clearance or approval of eight significant new in vitro diagnostic test biomarkers as the basis for treatment decisions as opposed to a tumor's location. |
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SEC Complaint: Keith Berman and Decision Diagnostics Corp
17 déc 2020 · Statements Berman and DECN made about FDA emergency use authorization were material to the market, including to investors and potential |
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UNITED STATES OF AMERICA Before the SECURITIES - SECgov
20 mai 2020 · Counsel for Decision Diagnostics Corp /s/ David knew that no COVID-19 test kits could be sold without FDA approval, which the company |
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Anthony Sanchez, et al v Decision Diagnostics Corp, et al 21-CV
28 déc 2020 · Expedited FDA EUA Approval For Genviro Swift :15 Virus Test Kit” 24 On May 12, 2020, Decision Diagnostics issued a press release touting, |
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Decision Diagnostics Corp Supplemental Disclosures
15 mai 2018 · Diagnostic Newco LLC from its owner Kimberly Binder Diagnostic completing its FDA 510k approval application, and then problems Shasta |
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FACT SHEET - Wall Street Reporter
Decision Diagnostics Corp is a worldwide regulated Our U S FDA approved GenUltimate and FDA cleared for use with OneTouch® Ultra®, Ultra®2, and |
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List of SARS-CoV-2 Diagnostic test kits and - The Global Fund
Board Decision on Additional Support for Country Responses to COVID-19 The COVID-19 diagnostic tests approved by the Ministry of Health, Labour and Welfare https://www fda gov/medical-devices/emergency-situations-medical- devices/ QIAGEN Rotor- Gene® Q real-time PCR cycler General Biologicals Corp |
