The amendments also allow the future use of "other specimen types" when requested by BioFire Defense, LLC and concurred with by FDA. FDA also concurred with the modifications to the (1) Instructions for Use, including wording in the intended use, to improve the overall clarity and accuracy of the document, and (2) Healthcare Provider and Patient Fact Sheets, that were requested by FDA. Verify your identity in apps and thirdparty workouts will give you an estimate of your calories to contribute to your daily move goal. Flexible and/or foldable electronic devices, and flexible, Storing and archiving data previously erased for economic reasons, Digital forensics, electronic discovery, malware detection, IT compliance, Deployed at various airports and federal security checkpoints, Hypothetical, experiments; some components of integrated circuits have been developed, Smaller, faster, lower power consuming computing, Much faster computing for some kinds of problems, chemical modeling, new materials with programmed properties, Hypothetical of, Making the web machine-readable by annotating data on the web based on its meaning. You will be subject to the destination website's privacy policy when you follow the link. FDA also concurred with the related updates to the Instructions for Use and the Fact Sheets for the Abbott RealTime ZIKA assay that reflect the addition of EDTA whole blood. The amendments also allow the future use of "other authorized instruments", of "other extraction methods" and of "other authorized specimen types" when requested by CDC and concurred with by FDA. There may be times in your life when sensitive files need to change hands, and an encrypted hard drive is essential to keeping those secrets secure. You can purchase physical Voice Changing Devices that interact with your phone for landlines and cell phones to filter your voice on calls. In fact, NordVPN gives you the ability to route your IP address and DNS settings through one of its more than 5,000 global servers. First, many cheap spy cameras are available on sites like Amazon and eBay that have abysmal reviews and come from sketchy overseas companies. This noise generator can create noise that replicates a crowded rooms ambient sounds, making it hard for microphones or eavesdropping ears to discern what youre saying. Follow food safety guidelines when handling and cleaning fresh produce. This action has two critical effects: it hides your IP address and encrypts all incoming and outgoing data. In response to CDC's request, on May 3, 2017 FDA concurred with the modifications to the authorized Instructions for Use labeling for the CDC Zika MAC-ELISA to (1) add the DynexTechnologies, Inc.'s Agility and DSX systems as acceptable automated instruments for use with the Zika MAC-ELISA, (2) add language recommending an additional negative human serum control be run once daily, (3) include a limitation concerning the use of the Hennessey detecting antibody conjugate 6B6C-1 in conjunction with the Vero E6 antigen when testing infant serum, and (4) update contact information. Entry-level devices, such as the night vision binoculars used by hunters, typically start at about $400, while military-grade night vision goggles can cost anywhere between $3,000-$10,000. Tracking and destruction of rockets, bombs, drones etc. In response to Siemens Healthcare Diagnostics Inc.'s request, on December 19, 2016 FDA concurred with the modification to the authorized VERSANT Zika RNA 1.0 Assay (kPCR) Kit Fact Sheets to combine the Fact Sheet for Patients and the Fact Sheet for Pregnant Women into one Fact Sheet for Patients and to include updated language to align with the latest CDC Zika Laboratory Guidance, implemented in November 2016. On February 26, 2016, pursuant to section 564(b)(1)(C) of the Act (21 U.S.C. That person is not cool. Adaptive structures that respond to different conditions, or supermassive buildings and infrastructure (e.g. Adaptive and individualized, Reflex is the most effective and fun system for mastering basic facts in addition, subtraction, multiplication and division for grades 2+. 'This study provides important data to suggest that implicit biases in OHCA exist, and that these biases may influence disparities in OHCA training, care, and outcomes. 7 Bond Gadgets Which Defy Reason and Practicality", "Chekhov's Gun is the movie trope that'll ruin everything once you know about it", "Top 10 James Bond Villain Gadgets 07. This affordable and compact spy gadget has a built-in USB stick so that you can easily access and save your files. He added that more research was needed to propose solutions to this problem. Lightweight and waterproof, it works under extreme weather conditions, has a 50-hour battery life, and can be attached to headgear. The coolest gadgets arent just for the big screen action stars. 's breakthrough can put 100 DVDs on a disc", "Remapping Computer Circuitry to Avert Impending Bottlenecks", "Shannon Airport deploys face recognition", "Quantum computing device hints at powerful future", "First Ever Commercial Quantum Computer Now Available for $10 Million", "Does quantum mechanics offer the best way to protect our most valuable data? Yoga lowers your blood pressure and slashes the risk of heart disease, study finds, John Ely Senior Health Reporter For Mailonline, Determining the Importance of Various GEnders, Races and Body Shapes for CPR Education Using Mannikins: Images in MedIa (DIVERSE II) - Canadian Journal of Cardiology. There is no evidence to suggest that handling food or consuming food can spread COVID-19. In response to CDC's request, on October 8, 2019 FDA concurred with the modifications to the Healthcare Provider and Patient Fact Sheets for the CDC Ebola Virus VP40 Real-time RT-PCR Assay to reflect changes to the CDC testing algorithm and updated epidemiological information concerning Ebola virus disease (EBV). Likewise, some regions have laws discouraging people from filming upskirt videos and other obscene materials. 'Choreographed' routine sees Harry putting on 'alpha display' while Meghan appears 'elegant throughout', says body language expert, Prince William says he will 'NEVER' watch Harry and Meghan's Netflix docuseries and tells friends NOT to retaliate at barbs against him because he's 'looking to the future' and intent on 'getting on with the job', sourcesclaim, Prince Harry has 'absolutely NO regrets' and is 'DELIGHTED' with his incendiary Netflix series that branded Britain 'racist', 'mocked' The Queen and contained multiple barbs at his brother William, Harry and Meghan are told to stay AWAY from King Charles's coronation: Political and military grandees warn couple they could face public BOOS at May's event after Netflix bombshells, William and Harry will be 'exchanging Christmas presents for their children but not for each other' as relations between estranged brothers hits new low following bombshell Netflix series, Thomas Markle says it WAS him texting Meghan from his sick bed before her wedding to Harry and reveals the proof - after Duchess told Netflix he never called her 'Meghan' so she assumed his phone had been 'compromised', Who lives in a house like this? The WeBoost Drive X reaches out to faraway cell towers providing a signal for your phone. If it finds something, it will let you know. Find the best deals on Family from your favorite brands. WebYou can decide where and when your keys can be used, and you can revoke them anytime. News. Woodblock printing: The earliest specimen of woodblock printing is a single-sheet dharani sutra in Sanskrit that was printed on hemp paper between 650 and 670 AD; it was unearthed in 1974 from a Tang tomb near Xi'an. This authorization is limited to the use of the authorized RealStar Ebolavirus RT-PCR Kit 1.0 on only specified instruments by CLIA high complexity laboratories. Place your other hand on top of your first hand and interlock your fingers. There is no evidence to suggest that handling food or consuming food can spread COVID-19. Zika Virus Emergency Use Authorization. 139160, Adams, R., Mann, G., & Hobbs, V. (2017). The Instructions for Use and Fact Sheet for Health Care Providers have also been updated to incorporate this amendment. A service like NordVPN routes your traffic through remote servers. A person witnessing a suspected cardiac arrest should call emergency services and start CPR if trained to do so and if it is safe. 360bbb-3(b)(1)), and on the basis of such determination, the Secretary of HHS then declared that circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for detection of Zika virus and/or diagnosis of Zika virus infection, subject to the terms of any authorization issued under 21 U.S.C. There are many reasons you wouldnt want a sensitive conversation to be overheard or recorded without you knowing. Ownership of vacuum flasks is predicted to increase by 44 per cent as an alternative to splashing out in coffee shops. Unrivaled access, premier storytelling, and the best of business since 1930. While there are about 30,000 OHCAs in the UK each year, just one in 10 people end up surviving. Drug overdose and losing a large amount of blood can also be to blame. Even if you dont have nefarious intentions, we advise our readers to research your local, state and national laws regarding hidden cameras and voice recordings. To receive email updates about COVID-19, enter your email address: We take your privacy seriously. On July 19, 2016 the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of Viracor-IBT Laboratories, Inc.'s ("Viracor-IBT") Zika Virus Real-time RT-PCR test for the qualitative detection of RNA from Zika virus in human serum, plasma or urine (collected alongside a patient-matched serum or plasma specimen) from individuals meeting Centers for Disease Control and Prevention (CDC) Zika virus clinical criteria (e.g., clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiologic criteria for which Zika virus testing may be indicated). I will never buy my child their doll, Georgia journalist is one of few people in world who's completely immune to ALL known variants of COVID and his blood would still kill virus even if it was diluted by 90%, Inspecting the dreamhouse! The amendments: (1) update nucleic acid extraction options authorized for use with the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel-Influenza A(H7) [Eurasian Lineage] Assay; (2) provide users with additional guidance on reporting/referring presumptive positive results to CDC; and (3) as described in Section IV. The Spot Trace will automatically start sending signals to you as soon as it detects movement and provides nearly real-time updates on the devices location. By Adrian Covert, Jonathan Knoder. Worried parents Sean Poulter Consumer Affairs Editor For The Daily Mail. Writing in theCanadian Journal of Cardiology, the experts presented the findings of theirDetermining the Importance of Various gEnders, Races and body Shapes for CPR Education (DIVERESE) study. The Idylla Ebola Virus Triage Test should be performed by laboratories in CLIA moderate and high complexity laboratories in the U.S. or in similarly qualified non-U.S. laboratories, by clinical laboratory personnel who have received specific training on the use of the Idylla Ebola Virus Triage Test on the Idylla System. Instead, create your own personal bubble with the Rabbler, one of the coolest spy gadgets weve found yet. Sales of modern air fryers are also up by 176 per cent. The science behind Bond", "No Time to Die: James Bond's Most Brutal Kill Isn't the Main Villain", "No Time to Die Clip Debuts James Bond's Latest Q Gadget", "No Time To Die: Every Bond Vehicle And Gadget Explained", "No Time to Die: James Bond's stunt car on show in Beaulieu", Review of the "Bond" Omega Seamaster Professional, Considerations for the role of James Bond, https://en.wikipedia.org/w/index.php?title=List_of_James_Bond_gadgets&oldid=1126687667, Short description is different from Wikidata, Articles that may contain original research from April 2019, All articles that may contain original research, Articles with unsourced statements from April 2019, Creative Commons Attribution-ShareAlike License 3.0, Twenty rounds of ammunition for the rifle concealed within the case. A Korean miniature dharani Buddhist sutra discovered in 1966, bearing extinct Chinese writing characters used only during the reign of China's only self-ruling empress, Kamal Khan's Loaded Backgammon Dice, Octopussy (1983)", "James Bond Film Gadgets and Devices Octopussy", "James Bond's Montblanc from Octopussy: The Sequel - Vintage Fountain Pens: Sheaffer, Parker, Inkwells, Buy Sell Trade at ThePenMarket.com", "PocketCalculatorShow.com Nerd Watch Fun! An added bonus beyond the added privacy, is it protects your screen as well. Autoblog brings you car news; expert reviews of cars, trucks, crossovers and SUVs; and pictures and video. The manufacturer Crockpot estimates that an electrical pressure cooker generally uses around 500W to cook an average stew in just 21 minutes, compared with 205 minutes to cook the same meal using around 3,000W in a conventional oven.. The amendments also include a new Fact Sheet for Asymptomatic Individuals Suspected of Exposure to MERS-CoV Cases and revisions to the Instructions for Use, and Fact Sheets for Health Care Providers and Patients. WebExclusive: Win As One campaign aims to build Commons majority among progressive parties Repeat these compressions at a rate of 100 to 120 times per minute until an ambulance arrives or you become exhausted. In response to altona Diagnostics GmbH's request, on March 6, 2017 FDA concurred with the following revisions to the emergency use authorization of the RealStar Zika Virus RT-PCR Kit U.S. issued on May 13, 2016: (1) update the Instructions for Use and Fact Sheets to include EDTA plasma as an authorized clinical specimen; and (2) update the Instructions for Use to include results of the FDA Reference Material testing with the RealStar Zika Virus RT-PCR Kit U.S. On April 28, 2016 the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of Focus Diagnostics, Inc.'s, Zika Virus RNA Qualitative Real-Time RT-PCR test for the qualitative detection of RNA from Zika virus in human serum specimens from individuals meeting Centers for Disease Control and Prevention (CDC) Zika virus clinical criteria (e.g., clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiologic criteria for which Zika virus testing may be indicated), by qualified laboratories designated by Focus Diagnostics, Inc., and, in the United States, certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), to perform high complexity tests. Anyone infected with COVID-19 can spread it, even if they do NOT have symptoms. A fixture in the homes of earlier generations, pressure cookers use a combination of heat, steam and high pressure to tenderise cheap cuts of meat and cook meals faster than an oven or hob. Research, development, prototypes, limited commercialization (e.g. This authorization was limited to the use of the authorized CDC Ebola Virus NP Real-time RT-PCR Assay on the Applied Biosystems (ABI) 7500 Fast Dx Real-Time PCR Instrument by qualified laboratories designated by CDC. The CDC Ebola Virus VP40 Real-time RT-PCR Assay can also be used with urine specimens when tested in conjunction with a patient-matched whole blood, serum, or plasma specimen. Academics from Canada and Argentina found fewer than 10 per cent of mannequins used to promote CPR on social media represented black or Asian people. A VPN can also let you access the dark web if youre interested in that sort of thing. WebThis is a list of emerging technologies, in-development technical innovations with significant potential in their applications.The criteria for this list is that the technology must: Exist in some way; purely hypothetical technologies cannot be considered emerging and should be covered in the list of hypothetical technologies instead. And with the base (not included) you can connect up to four cameras at once. Testing is performed by qualified laboratories designated by CDC and, in the United States, certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. And since were at the mercy of big tech companies to keep our online and mobile behavior safe, many people are investing in their own spy equipment to ensure their private internet activity is secure: VPN cybersecurity technology. In response to CDC's request on November 15, 2016, FDA concurred with the modification to the CDC algorithm for results confirmation of the Zika MAC-ELISA as outlined in the updated CDC Guidance for U.S. Laboratories Testing for Zika Virus Infection (revised). The Gareth Southgate effect! The amendments allow, in addition to altona Diagnostics GmbH, distributors that are authorized by altona Diagnostics GmbH to distribute the RealStar Ebolavirus RT-PCR Kit 1.0 with certain conditions applicable to such authorized distributor(s). Studies in Closed Ecological Systems: Biosphere in a Bottle, Frieda B. Taub Annual Review of Ecology and Systematics Vol. On November 21, 2016, the FDA issued an Emergency Use Authorization (EUA) for emergency use of Abbott's RealTime Zika assay for the qualitative detection of RNA from Zika virus in human serum, EDTA plasma and urine (collected alongside a patient-matched serum or plasma specimen) from individuals meeting Centers for Disease Control and Prevention (CDC) Zika virus clinical criteria (e.g., clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiological criteria for which Zika virus testing may be indicated), by laboratories in the United States (U.S.) that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. Because this assay may be distributed outside the U.S., the amendments also allow the use of this assay under this EUA, with certain conditions, at non-U.S. laboratories that are similarly qualified as CLIA High Complexity Laboratories. The original books and early adaptations had only relatively minimal pieces like the modified attache case in From Russia, with Love. With a single personal subscription for $3 a month, you can use 1Password on all of your devices and receive notifications when your passwords are vulnerable so you can make changes. Mannequins used to practice life-saving CPR aren't diverse enough, doctors have claimed. Zika virus RNA is generally detectable in these specimens during the acute phase of infection and, according to the updated CDC Guidance for U.S. Laboratories Testing for Zika Virus Infection, up to 14 days in serum and urine (possibly longer in urine), following onset of symptoms, if present. This test is for the presumptive detection of novel influenza A (H7N9) virus in conjunction with the FDA cleared CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel in real-time RT-PCR (rRT-PCR) assays in patients with signs and symptoms of respiratory infection. Life-saving CPR training is used to help bystanders improve the odds of survival if someone suffers a cardiac arrest, a sudden loss of heart function. If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. Researchers want to ditch the reliance on default 'lean white male' models. The Instructions for Use and Fact Sheet for Health Care Providers have also been updated to incorporate these amendments. You can review and change the way we collect information below. These droplets and particles can be breathed in by other people or land on their eyes, noses, or mouth. In an editorial published in the same journal researcher Nicholas Grubic, also of Queens Department of Medicine, said the researchers had highlighted a concerning issue that should be addressed by public health authorities. Their new research follows on from an audit of themannequins used in CPR certification courses which found the vast majority use the lean white male model, an issue they described as 'problematic'. It does not include makeshift gadgets or weapons, animals, or general spy equipment and installations such as disguises / fake passports, surveillance equipment, secret passages / trap doors, remote-controlled detonations, unless particularly notable. It isnt very easy to accomplish any work when your device is running low on data. self-health monitoring, Significantly stronger metal components (particularly in aircraft jet engines). Cardiopulmonary resuscitation (CPR) can be used to try to restart someone's heart if it has stopped. On February 6, 2015, pursuant to section 564(b)(1)(C) of the Act (21 U.S.C. In response to Hologic Inc.'s request, on September 7, 2016 FDA concurred with the revision to add processed urine (collected alongside a patient-matched serum or plasma specimen) as an authorized specimen under the emergency use authorization of the Aptima Zika Virus Assay issued on June 17, 2016. 247d-6b), that the Ebola virus presents a material threat against the United States population sufficient to affect national security. Get breaking news stories and in-depth coverage with videos and photos. Suppose you want to ensure you arent left high and dry, especially when driving out in the middle of Timbuktu. WebYou can use the Google Pay app for fast, simple, and secure online payments. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. In response to CDC's request to amend this EUA, on June 10, 2014 FDA reissued the June 5, 2013, EUA in its entirety with the CDC-requested amendments incorporated. However, early CPR doubles the odds of patient survival. On March 17, 2016, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of Centers for Disease Control and Prevention's (CDC) Trioplex Real-time RT-PCR Assay (Trioplex rRT-PCR) for the qualitative detection and differentiation of RNA from Zika virus, dengue virus, and chikungunya virus in human sera or cerebrospinal fluid (collected alongside a patient-matched serum specimen), and for the qualitative detection of Zika virus RNA in urine and amniotic fluid (each collected alongside a patient-matched serum specimen). These can include audio bugs, Wi-Fi cameras, IP cameras, GSM bugs, wiretaps, body wires, GPS trackers, phone taps, or other types of surveillance bugs in the room. Part of the Daily Mail, The Mail on Sunday & Metro Media Group. Jared and Ivanka take a family stroll to check the progress of their $24 MILLION 'Billionaire Bunker' mansion in Indian Creek, General CPR guidelines are the same for all adults including for pregnant women. Journal of Power Sources,196:p.886-893. On October 25, 2014, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of the BioFire Defense, LLC's FilmArray NGDS BT-E Assay for the presumptive detection of Ebola Zaire virus (detected in the West Africa outbreak in 2014) in whole blood specimens from individuals with signs and symptoms of Ebola virus infection or who are at risk for exposure or may have been exposed to the Ebola Zaire virus (detected in the West Africa outbreak in 2014) in conjunction with epidemiological risk factors. Its easy to install and has 1080p video quality for both day and night. Where there are positive or equivocal results from the Zika MAC-ELISA, confirmation of the presence of anti-Zika IgM antibodies requires additional testing by CDC, or by authorized laboratories in consultation with CDC, using the CDC-issued algorithm. Learn what you should do if you have pets. Centers for Disease Control and Prevention. An artificial environment where the user feels just as immersed as they usually feel in conscious reality. Keeping your hands on their chest, release the compression and allow the chest to return to its original position. On September 28, 2016, the FDA issued an Emergency Use Authorization (EUA) for emergency use of ARUP Laboratories' Zika Virus Detection by RT-PCR test for the qualitative detection of RNA from Zika virus in human serum, EDTA plasma and urine (collected alongside a patient-matched serum or EDTA plasma specimen) from individuals meeting Centers for Disease Control and Prevention (CDC) Zika virus clinical criteria (e.g., clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiological criteria for which Zika virus testing may be indicated). This is a list of James Bond gadgets featured in the Bond films, organized by the film eras of its actor.. Linking to a non-federal website does not constitute an endorsement by CDC or any of its employees of the sponsors or the information and products presented on the website. The assay is intended for use with specimens collected from individuals meeting CDC Zika virus clinical criteria (e.g., clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiologic criteria for which Zika virus testing may be indicated as part of a public health investigation). One of the easiest way to manage all of your online passwords is with a password manager like 1Password. The Instructions for Use and Fact Sheets also have been updated to incorporate these revisions, and the Pregnant Women Fact Sheet and Patient Fact Sheet were combined into one Patient Fact Sheet. 360bbb-3(a). Hypothetical, research, commercialization (e.g. When youre up to secret spy activity, you have to have spy gear that prevents other people from eavesdropping on the information you have. What does VPN technology do? And, yes, it actually tells time. Regardless whether youre taking video by land or sea, the 1140p video will look crisp and stabilized, even when youre on the move. A iPhone 13 Pro Max privacy screen protector keeps anyone from rubbernecking to secretly see whats on your phone. When we initially wrote this article, we decided not to include any hidden cameras in the spy gadgets featured above. On April 25, 2014, the FDA issued an Emergency Use Authorization (EUA) for the "A/H7N9 Influenza Rapid Test" manufactured by Arbor Vita Corporation. Law enforcement uses thermal imaging to pick up heat from a person or object, even if theres a solid surface concealing it. In response to DoD's request to amend this EUA, on October 10, 2014 FDA reissued the August 5, 2014, EUA in its entirety with the DoD-requested amendments incorporated. Simply opening up a scalding metal pan filled with high-pressure steam was something of a lottery with many fearing the lid would explode across the kitchen. Emergency Situations (Medical Devices), Recalls, Market Withdrawals and Safety Alerts, Emergency Use Authorizations for Medical Devices, Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices, Monkeypox Emergency Use Authorizations for Medical Devices, EUAs for Coronavirus Disease 2019 (COVID-19), 2015 Enterovirus D68 (EV-D68) Emergency Use Authorization, 2014 Ebola Virus Emergency Use Authorizations, 2013 Coronavirus Emergency Use Authorization (Potential Emergency), 2013 H7N9 Influenza Emergency Use Authorization (Potential Emergency), CII-ArboViroPlex rRT-PCR Assay (Columbia University), TaqPath Zika Virus Kit (Thermo Fisher Scientific), Gene-RADAR Zika Virus Test (Nanobiosym Diagnostics, Inc.), Zika ELITe MGB Kit U.S. (ELITechGroup Inc. Molecular Diagnostics), Zika Virus Detection by RT-PCR Test (ARUP Laboratories), VERSANT Zika RNA 1.0 Assay (kPCR) Kit (Siemens Healthcare Diagnostics Inc.), Letter Granting EUA Amendment(s) December 19, 2016, Zika Virus Real-time RT-PCR Test (Viracor Eurofins), RealStar Zika Virus RT-PCR Kit U.S. (altona Diagnostics), Zika Virus RNA Qualitative Real-Time RT-PCR (Quest Diagnostics Infectious Disease, Inc.), EV-D68 2014 rRT-PCR Assay (CDC) - May 12, 2015, EZ1 Real-time RT-PCR Assay (DoD) - October 10, 2014, CDC Ebola Virus NP Real-time RT-PCR Assay (CDC) - March 2, 2015, CDC Ebola Virus VP40 Real-time RT-PCR Assay (CDC) - March 2, 2015, FilmArray Biothreat-E Test (BioFire Defense, LLC) - October 25, 2014, Letter Granting EUA Amendment(s) (November 12, 2019), FilmArray NGDS BT-E Assay (BioFire Defense, LLC) - March 2, 2015, RealStar Ebolavirus RT-PCR Kit 1.0 (altona Diagnostics GmbH) - November 26, 2014, LightMix Ebola Zaire rRT-PCR Test (Roche Molecular Systems, Inc.) - December 23, 2014, Xpert Ebola Assay (Cepheid) - March 23, 2015, Idylla Ebola Virus Triage Test (Biocartis NV) - May 26, 2016, DPP Ebola Antigen System (Chembio Diagnostic Systems, Inc.) - November 9, 2018, determined that Middle East respiratory syndrome coronavirus (MERS-CoV) poses a significant potential for a public health emergency, CDC Novel Coronavirus 2012 Real-time RT-PCR Assay (CDC) - June 10, 2014, RealStar MERS-CoV RT-PCR Kit U.S. - February 12, 2016, Fact Sheet for Asymptomatic Individuals Suspected of Exposure to MERS-CoV Cases, determined that avian influenza A(H7N9) poses a significant potential for a public health emergency, Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel-Influenza A(H7) [Eurasian Lineage] Assay (CDC) - March 27, 2018, Lyra Influenza A Subtype H7N9 Assay (Quidel Corporation) - February 14, 2014, A/H7N9 Influenza Rapid Test (Arbor Vita Corporation) - April 25, 2014, Historical Information about Device Emergency Use Authorizations, Letter: Termination of Declaration of Emergency Justifying Emergency Use Authorization (EUA) of Certain In Vitro Diagnostic Tests (6/22/10) [ARCHIVED], Letter: Termination of Declaration of Emergency Justifying the Authorization of Emergency Use of Certain Personal Respiratory Protection Devices (6/22/10) [ARCHIVED], Letter: Disposition of Certain Personal Respiratory Protection Devices Authorized for Emergency Use (6/22/10) [ARCHIVED], Federal Register: Termination of Declarations Justifying Emergency Use Authorizations of Certain In Vitro Diagnostic Devices, Antiviral Drugs, and Personal Respiratory Protection Devices (6/25/10), Tri-Agency Task Force for Emergency Diagnostics (TTFED) Press Release, Information for Laboratories Implementing IVD Tests Under EUA, How to Submit a Pre-EUA for In vitro Diagnostics to FDA, OCET - Medical Countermeasures Initiative, Emergency Use Authorization of Medical Products and Related Authorities, CDC Information on Avian Influenza A (H7N9) Virus, Questions About Personal Protective Equipment (PPE). 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