abbott binaxnow expiration date location

She is a journalism graduate of Mizzou and Northwestern. Facilities should keep a copy of the referenced document for any Some are good for six months, some for nine, some for 11. This site does not include all credit card companies or all available credit card offers. One of the benefits of at-home tests is that they can be done frequently and provide answers within minutes. With just a one-day window to get a negative COVID-19 test before flying back to the U.S., select at-home test kits like the Abbott BinaxNow COVID-19 Home Test have become incredibly popular for international travel. Sites can then locate their lot #(s) on the list provided and find their expiration date ; Current expiration dates for BinaxNOW professional (i.e., on-site administration) tests can be found on the Abbott website. Testing has been completed to support a shelf -life (expiration date) of up to 9 months. At-Home Rapid COVID-19 Testing Expiration Dates -Check the expiration date on your test kit. Abbott has now informed DHS of the test kit lot numbers for which the expiration date is extended. Plus, your own feed of TPG content. If you have a negative result, it does not rule out SARS-CoV-2 infection; you may still be infected and you may still infect others. The products and information contained herewith may not be accessible in all countries, and Abbott takes no responsibility for such information which may not comply with local country legal process, regulation, registration and usage. 2023 Abbott. 10 Standing Order Who can collect specimens? GDPR Statement (last updated: May 2018) | California Transparency in Supply Chains Act | Declaration for California Compliance Law. Abbott did not respond to a request clarifying why some people are not receiving the note. You can find the expiration date on the front of your BinaxNow home test. The CDC guidelines require all travelers, regardless of vaccination status, to show a negative COVID-19 test result before boarding a plane to the U.S. (TPG reported last summer that the wait times for BinaxNow supervised exams through Zoom were quite long due to high demand, but wait times have improved.). This first-of-its kind service for COVID-19 testing ships tests directly to your home and uses trained, virtual proctors to guide you through the test via video call. No, this is for personal use only and doesnt provide a documented test result that you can display when traveling. Abbott is intently monitoring the mutations of COVID so we can ensure our tests can detect them, as we do with many viruses. The test kits have an original expiration date of September 2021, October 2021, and November 2021. Just pack a test in your bag (or two just in case), fire up the eMed site to get an appointment with a supervised exam started, perform the test, and get results in your inbox soon after. Earn 5X Membership Rewards Points for flights booked directly with airlines or with American Express Travel up to $500,000 on these purchases per calendar year and earn 5X Membership Rewards Points on prepaid hotels booked with American Express Travel. Abbott has informed users that further testing has authorized use of some tests up to nine months, three months beyond the original expiration dates. ALWAYS BE READY WITH THE #1 COVID19 SELF TEST IN THE U.S.*. When you reach for your stash of BinaxNOW Self Tests whether you're experiencing symptoms or had a recent exposure it's important to ensure your test and the components aren't expired. It has been authorized only for the detection of proteins from SARSCoV-2, not for any other viruses or pathogens, and is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. This is the specific name that is on the test kit. Upon calling the company, he was told that all expiration dates had been extended for an extra three months. For Use Under an Emergency Use Authorization (EUA) Only. Abbott BinaxNOW Ag Home Tests Guidance Document Background Ohio partnered with Abbott and eMed to bring rapid, reliable testing into the home where the result is delivered in minutes. The BinaxNOW COVID-19 Self Test is identical to the professional-use test, used since August 2020. This site does not include all credit card companies or all available credit card offers. Theyre pretty stable for over a year.. The BinaxNow COVID-19 test kits were originally made in a bulk in late 2020 thru early 2021 and was approved for testing by the FDA under the EUA (Emergency Use Authorization). "Upon determining that a portion of our test kits were reporting higher than expected false-positive test results, we worked quickly with the Food and Drug Administration (FDA) to voluntarily recall the problematic test kits and correct the issue," Ellume founder and CEO Dr. Sean Parsons said at the time. See what a point or mile is worth with our appraisals of a loyalty programs currency, based on redemption values. Follow the Instructions for Use regarding serial testing. Learn more. Testing has been completed to support a shelf-life (expiration date) of up to 15 months. 1 / 11/2023 . The credit card offers that appear on the website are from credit card companies from which ThePointsGuy.com receives compensation. However, if you have symptoms of COVID-19, and your first test is negative, you should test again in 48 hours since antigen tests are not as sensitive as molecular tests. Family Care Rate Survey: Responses Needed! xkoFH$OnurFs@r(dKI;3*se8>xBYKwlq| 3.`d\;sv55GlT^3X_GG) Cp zHuRWT%l*2apZ7 .3tdU"5IZC[.! According to the FDA, this is due to some variation in stability testing. As was reported last week, DHS was notified on Tuesday, January 11, by Abbott of its decision on January 7 to extend by three months the expiration date for certain BinaxNow antigen rapid test kits. URL addresses listed in MMWR were current as of the date of publication. is an Emmy Award-winning TV producer who has worked for NBC, CBS and ABC, to name just a few. Earn 80,000 Membership Rewards points after you spend $6,000 on purchases on your new Card in your first 6 months of Card Membership. Make sure youre looking at the expiration date. Each product box has an expiration date and should not be used after that date. If this happens to you, we suggest checking with the testing company. They are still fine, according to WHEC, the NBC affiliate in chilly Rochester, N.Y., which posed that question to manufacturers. Check here before booking an award fare. All rights reserved. Learn more. $200 Uber Cash: Enjoy Uber VIP status and up to $200 in Uber savings on rides or eats orders in the US annually. has a printed expiration date. nL42LtT:36D]K '$B Read more TOM GRALISH / Staff Photographer by Tom Avril Published Jan 21, 2022 Our opinions are our own, and have not been reviewed, approved, or endorsed by our advertising partners. BinaxNOW COVID-19 Antigen Self Test + NAVICA. % For i-STAT test cartridge information and intended use, refer to individual product pages or the cartridge information (CTI/IFU) in the i-STAT Support area. Photos displayed are for illustrative purposes only. You can find the lot number for your. Next CMS Skilled Nursing Facilities/Long Term Care Open Door Forum Will be Held on January 27, Public Health Emergency Renewed an Additional 90 days, Reminder! There are even more places your Platinum Card can get you complimentary entry and exclusive perks. Indicated for children as young as 2 years old when administered by an adult, and for all people 15 and older to self-administer. . Improve earnings, maximize rewards and track progress toward dream trips. Earn 80,000 Membership Rewards points after you spend $6,000 on purchases on your new Card in your first 6 months of Card Membership. a three-month extension on the expiration date, USPS reaches agreement to deliver COVID-19 test kits, with Philly part of pilot program, some other manufacturers have been extended as well. "So, if you didn't know then you might be in for a shock!". Abbott recently received an extension from the U.S. FDA for BinaxNOW Self Tests from 15-month expiration dates to 22-months. Does the product expire? November 1, 2022. If coronavirus proteins are present in the sample, the antibodies bind to them in such a way that the strip changes color, said Volk, chief medical officer at Baptist Health Floyd Hospital in New Albany, Ind. Abbott - A Leader in Rapid Point-of-Care Diagnostics. Your use of this website and the information contained herein is subject to our Website Terms and Conditions and Privacy Policy: US Citizens | Non-US Citizens. Member Action Needed! 2783 0 obj <> endobj Abbott will also. Use the instructions to see the letter and listing of BinaxNOW COVID-19 Ag Card lots which qualify for this expiry extension. Everybody knows now, the energy sector was the place to be last year as the segment was an outlier and one of the few to sidestep 2022's market carnage. Visit your local pharmacy to request no-cost tests using your insurance. More than 800,000 rapid COVID-19 tests passed their expiration date recently in a Florida warehouse, prompting concerns that they would go to waste. Now, travelers have more time. Earn 80,000 Membership Rewards points after you spend $6,000 on purchases on your new Card in your first 6 months of Card Membership. The high annual fee is only worth it if youre taking full advantage of the cards benefits. Abbott has conducted a computational analysis of the detection of multiple SARS-CoV-2 strains, including the Delta and Omicron variants and predicts no impact to the performance of our BinaxNOW COVID-19 Antigen Self Test. 2831 0 obj <>stream Here are the instructions how to enable JavaScript in your web browser, FSA/HSA Eligible. You may contact the Section for Long-Term Care Regulation (SLCR) at 573-526-8524. Page 1 of 32 BinaxNOW COVID-19 Ag Card Product Expiry Update January 2022 Dear Valued Customer: Since the launch of the BinaxNOW COVID-19 Ag Card, Abbott has continued testing for product stability to extend the expiration date and have shared these results with the FDA. Individual components inside the box will have varying expiration dates, do not pay attention to those dates only the expiration date on the outside of the box beside the hour glass icon. Consider using a proctored or teleheath-led self test, or contact your healthcare professional. Uber Cash and Uber VIP status is available to Basic Card Member only. "Essentially, this meant that I have an additional three months to use them so rather than expiring Sept. 28, 2021, (which would've been prior to our trip), they now expire on Dec. 28, 2021. The back of this Abbott BinaxNOW rapid COVID-19 test has an original expiration date of Oct. 16, 2022, printed next to the image of an hourglass, but the expiration dates for many such tests have been extended. For symptomatic use, a single test can be used. Please view our advertising policy page for more information. Travelers with one of these tests in hand may want to confirm their new expiration dates with either eMed or Optum before banking on using them for an upcoming international trip. Providing information and guidance for Long-Term Living Providers - Skilled Nursing, Intermediate Care, Assisted Living and Residential Care Homes. They have a shelf life. For documented results, consider using a proctored or teleheath-led self test, or contact your healthcare professional. Abbott will also conduct verification for the email address prior to providing expiry information. Seldom travelers may not get enough value to warrant the cost. Our team of researchers have confirmed that our BinaxNOW tests continue to detect the Omicron variant and its sub-variants, including XBB.1.5. Its really no different than when your medications expire, Volk said. Maine, and some of those had recently been labeled with new expiration dates. That means some. It may seem obvious, but read the instructions. ** Contact your health insurance provider to determine reimbursement eligibility. https://www.fda.gov/media/162799/download, California Transparency in Supply Chains Act, Declaration for California Compliance Law, instructions how to enable JavaScript in your web browser, A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens, Test kit dimensions: 9.125 L x 0.938 D x 5.063 H, Kit contains all necessary components for testing, including: 2 BinaxNOW COVID-19 Antigen Self Test Cards, 2 Nasal Swabs, 2 Reagent Bottles, Store between 35.6-86 F (2-30 C) until use. Optum prices are more expensive than eMed's but you won't have to buy six that you may not be able to use. Missouri Department of Health and Senior Services, COL-03031 v03 BinaxNOW COVID-19 Ag Card Product Expiry Update (002), Guidance for the Interim Final Rule Medicare and Medicaid Programs; Omnibus COVID-19 Health Care Staff Vaccination, Centers for Disease Control and Prevention, Missouri Association of Nursing Home Administrators, Missouri Coalition Celebrating Care Continuum Change (MC5), SLCR Newsletters and Provider Information, Funding Opportunity for Missouri Nursing Facility Strike Team and Infrastructure Award, Public Health Emergency (PHE) 1135 Waivers: Updated Guidance for Providers, Pre-Admission Screening and Resident Review (PASRR) Flexibility Ending May 11, 2023, iQIES for Minimum Data Set (MDS) Submission Release on April 17, 2023. Please pay close attention to the lot number, currently labeled kit expiry, and new kit expiry date. In January, the FDA extended the recommended shelf life of Abbott's BinaxNOW test kits from 12 to 15 months, based on data from the company. 4 0 obj Travelers staring down rapidly approaching expiration dates on their Abbott BinaxNOW tests can breathe easy, as they now have a 15-month shelf-life after yet another extension. New Expiration Dates as of 5/11/21 Total Received. But be aware that with the COVID antigen tests, the expiration date may be a moving target. The U.S. Food and Drug Administration has extended the shelf life of up to 1 million rapid COVID-19 tests that had expired in a Florida warehouse. Users of the BinaxNOW COVID-19 Ag Card are urged to check the lot numbers and expiration dates of their tests. This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 15 years or older or adult collected anterior nasal (nares) swab samples from individuals 2 years or older. Check with your local representative for availability in specific markets. For a crash course on what is meant by expiration in this context, and how to make sure your test is still OK, we spoke to Emily Volk, president of the College of American Pathologists, and Matthew Pettengill, director of clinical microbiology at Thomas Jefferson University Hospital. The test uses a nasal swab, control swabs, and test cards. To be on the safe side, use a test that has not expired. See results in just 15 minutes. If they didnt honor the prior FDA guidance, why would they follow this one? For full functionality of this site it is necessary to enable JavaScript. Learn how to use the BinaxNOW COVID-19 Antigen Self Test. Since the launch of the BinaxNOW COVID-19 Ag Card, Abbott has continued testing for product stability to extend the expiration date and has shared these results with the FDA. Credit ranges are a variation of FICO Score 8, one of many types of credit scores lenders may use when considering your credit card application. Even with a previous extension as far out as 12 months outlined in a slip inside the box her tests would still expire in early February 2022, weeks away. Test description . The expiration dates of the lot numbers listed in the referenced link have been extended to 12 months. Cost includes $12.95 plus applicable local sales tax. Improve earnings, maximize rewards and track progress toward dream trips. Get up to $300 back per calendar year on the Equinox+ digital fitness app, or eligible Equinox club memberships when you pay with your Platinum Card. . A single at-home COVID-19 test by Quidel sits on a drugstore shelf on Sept. 14, 2021, in Chicago. Am I able to get a record of my results from the BinaxNOW COVID-19 Antigen Self Test? Abbott BinaxNOW COVID-19 Ag Card Point of Care Diagnostic Test (antigen test) results, N1 cycle threshold . This compensation may impact how and where products appear on this site (including, for example, the order in which they appear). Providing information and guidance for Long-Term Living Providers - Skilled Nursing, Intermediate Care, Assisted Living and Residential Care Homes. No, this is an antigen test that only detects an active infection. A second, earlier date the day the test kit was assembled is typically printed below that, next to a mysterious-looking icon with a jagged line. Be sure to look out for the below note about calculating a test's expiration date, which directs you to add an additional three months to the date listed. Opinions expressed here are the authors alone, not those of any bank, credit card issuer, airline or hotel chain, and have not been reviewed, approved or otherwise endorsed by any of these entities. Available under FDA Emergency Use Authorization. In this process, "the manufacturer . Alternatively, click YES to acknowledge and proceed. Earn 5X Membership Rewards Points for flights booked directly with airlines or with American Express Travel up to $500,000 on these purchases per calendar year. The Food and Drug Administration (FDA) has authorized an expiry extension for BinaxNOW tests for three months from the current expiration date listed on the external box. Apply and select your preferred metal Card design: classic Platinum Card, Platinum x Kehinde Wiley, or Platinum x Julie Mehretu. In exchange for the annual fee, you'll unlock access to the Amex Membership Rewards program that let you access airline and hotel transfer partners, along with new lifestyle and travel credits. The entire process has never taken more than 20 to 25 minutes total. . 3-month extension on the printed expiration dates. You can self report up to 2 test results a day, per profile in NAVICA. At-home rapid tests. The Abbott BinaxNOW test is combined with eMed telehealth services which means a certified guide will guide a person through the test via video. Abbott recently received an extension from the U.S. FDA for BinaxNOW Self Tests from 15-month expiration dates to 22-months. Although wait times appear to have decreased, there's a new issue regarding expiration. BinaxNOW: Expiration Dates and Facing the "Kraken". With the number of cases still high, youll likely be using the test long before that date anyway. BinaxNOW is FSA/HSA eligible and reimbursable through most health insurance plans. Abbott says its tests can be stored between 36 and 86 degrees Fahrenheit, but the kits should be at room temperature when they are used. The news was first reported by Kyle Potter at Thrifty Traveler. Register TODAY to be Entered to Win $500! The shelf lives for tests from some other manufacturers have been extended as well. And to have perpetually confounding nick-names, such as the most recent "Kraken" variant. endstream endobj startxref I lucked up on my order. Earn 5X Membership Rewards Points for flights booked directly with airlines or with American Express Travel up to $500,000 on these purchases per calendar year. Enrollment required. <>/ExtGState<>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/Annots[ 21 0 R 22 0 R 23 0 R] /MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S>> A one-pack costs $50, a two-pack costs $69 and a three-pack costs $99. 3 0 obj Ron DeSantis. Card Rating is based on the opinion of TPGs editors and is not influenced by the card issuer. Page 1 of 12 Abbott Diagnostics Scarborough, Inc.: BinaxNOW COVID-19 Ag Self Test . READ MORE: USPS reaches agreement to deliver COVID-19 test kits, with Philly part of pilot program. Can people use HSA/FSA accounts to purchase the test? G.!^A$m# r;!-1dcGCv:!z_.n'n=5u( [z{5A;]%+/u-{7,-$ [x7-my_")|pr@1/R(gA^%C}|?@\;#@)T+RJY$2>!%`2*"aBooQQJ Q"CqbGT'V0BkV?gCD wKybUR%?IA[B1 J!%K-jx6s$W_R'b0j]` p(f$%N&EEm*= Q?~IK,'nQN@SO?m C?&2\my4"38psIJ}[e+YC2l$D. Some of us have received tests for future use, only to find an expiration date that's already passed. I n a ddi t i o n t o r a pi d a n t i g e n P O C t e s t s , r a pi d mo l e cu l a r P O C t e s t s a n d RT - P CR t e s t s , t h e F D A Bandages. On Oct. 1, Ellume voluntarily recalled more than 2 million tests, citing "higher-than-acceptable false-positive test results" falsely indicating that a user had tested positive for the coronavirus. Current test kit expiration dates may be as early as. Your email address will not be published. Check here before booking an award fare. and Abbott Laboratories, the manufacturers of the BinaxNow test THE ANSWER The expiration date to use for a BinaxNow testing kit is on the label and marked with an hourglass shape. It is not the bank advertisers responsibility to ensure all posts and/or questions are answered. $200 Airline Fee Credit: Get up to $200 in statement credits per calendar year in baggage fees and more at one select qualifying airline. 2023 Thrifty Traveler. Which is why we're sharing the latest updates with our BinaxNOW COVID-19 Self Tests so they can continue to have a positive impact in your lives even as COVID-19 and its many variants including the XBB.1.5 or "Kraken" you may have recently heard about continue to change. The shelf life was extended to 12 months, Aly Morici, a spokesperson for . While this was good news for the longevity of the tests, it meant that the expiration date written on tests distributed before this approval may no longer be accurate. Afterward, they dont work as well.. If anyone on our team wouldnt recommend it to a friend or a family member, we wouldnt recommend it on The Points Guy either. Earlier this month, Gov. Any organizations with tests currently expired are encouraged to check expiration dates as this FDA announcement allows use of expired tests up to three months from current expiration date. While the Omicron variant contains mutations to the spike protein, our tests do not rely on the spike gene to detect the virus. You can look up the revised expiration date by lot number (listed on the box of tests) using the FDA helper sheet for BinaxNOW Ag Card Home Tests and BinaxNOW Ag Self Tests. Enrollment required. The 15-minute BinaxNOW COVID-19 Ag Card Home Test has received FDA Emergency Use Authorization for at-home testing in collaboration with eMed, a digital health solution. VDH and MRC Personnel Authorized to Collect Anterior Nasal Specimens: Registered Nurses (RNs) Licensed Practical Nurses (LPNs) serving under the supervision of an International travelers catch a break as FDA extends expiration date for at-home COVID-19 test, This post contains references to products from one or more of our advertisers. Researchers gain the most accurate data from real-time testing, according to the FDA. Sometimes it's worth a large investment to reap the benefits of a great credit card. Abbott BinaxNow COVID-19 Antigen Tests EXTENDED to 15 months The expiration dates of the lot numbers listed in the referenced link have been extended to 15 months from the date of manufacture.Abbott has now informed DHS of the test kit lot numbers for which the expiration date is extended. Each kit box contains 2 test cards, 2 nasal swabs and 2 reagent bottles. They make the process of obtaining the required negative COVID test result much less of a hassle. You may contact the Section for Long-Term Care Regulation (SLCR) at 573-526-8524. Hes author of books such as the recent Wolverine: Creating Marvels Legendary Mutant. He also was executive producer of the SYFY Originals documentary, Todd McFarlane: Like Hell I Wont.. BinaxNOW, a rapid antigen test made by Abbott, can provide results in 15 minutes. Despite the product's shelf life extension, the earlier manufactured tests had components with varying . Compare the cost in points or miles to cash, and see which option is best. This card comes with a long list of benefits, including access to Centurion Lounges, complimentary elite status with Hilton and Marriott, at least $500 in assorted annual statement credits and so much more. This test is not sufficient for proof of a negative COVID-19 test for travel purposes. American Express has expanded The Centurion Network to include 40+ Centurion Lounge and Studio locations worldwide. For example, TPG senior editor Clint Henderson received several BinaxNow tests with an expiration date of Oct. 15, 2021. The BinaxNOW COVID-19 tests have not been FDA cleared or approved. This follows a request by the company to provide a longer shelf life for its test, after it reported stability studies that showed the tests remained accurate and consistent over the longer time period. CareStart tests distributed through the federal. Tissues. There are even more places your Platinum Card can get you complimentary entry and exclusive perks. BinaxNOW COVID-19 Antigen Self Test from Abbott can be used to detect active infection, with or without symptoms. Look on the back of your box for both the expiration date (next to the hourglass symbol) and lot number (next to the words LOT). Antigen tests have demonstrated positive percent agreement as high as 100% for symptomatic patients (3 serial tests, 2 days after first PCR positive) and as high as 88.9% for asymptomatic patients (3 serial tests, 6 days after first PCR positive) in an independent study conducted by the National Institutes of Health.1. That's exactly the case with the Amex Platinum card. Download the Extension Letter for more information. Get our daily email for the latest in travel, flight deals, and how to save on your next trip. Best card for premium perks while traveling, Capital One Venture X Rewards Credit Card, The Business Platinum Card from American Express, The best places to see cherry blossoms around the US this spring, Looking back: How my points and miles strategy has changed over the years, The best increased card offers to sign up for this March. Uber Cash and Uber VIP status is available to Basic Card Member only. covers news and travel for TPG. BinaxNow COVID-19 Antigen Rapid Self-Test at Home Kit | Walgreens Skip to main content Extra 15% off $40&plus; vitamins Weekly Ad Up to 50% off clearance Menu Find a Store Prescriptions Back Prescriptions Expiration details by test type: ABBOTT BinaxNOW: The FDA has approved an amended EUA for Abbott BinaxNOW antigen tests, extending the effective shelf-life. In the case of Abbotts BinaxNOW tests, the date is printed alongside a small icon of an hourglass. The annual airline fee statement credit can be complicated to take advantage of compared to the broader travel credits offered by competing premium cards. If you feel pain, please stop the test and seek advice from a healthcare provider. Get $200 back in statement credits each year on prepaid Fine Hotels + Resorts or The Hotel Collection bookings, which requires a minimum two-night stay, through American Express Travel when you pay with your Platinum Card. 15-month to 22-month shelf-life extension granted by the FDA December 21, 2022 Use the instructions to see the letter and listing of BinaxNOW COVID-19 Ag Card lots which qualify for this expiry extension. Generally, the tests are designed to be stable at a wide range of temperatures. But the exact date in each case is an open question, in part because some of the manufacturers are new at this game. American Express has expanded The Centurion Network to include 40+ Centurion Lounge and Studio locations worldwide. Abbott has now informed DHS of the test kit lot numbers for which the expiration date is extended. P rotect. DHS recently reported that they were notified in the late afternoon on Tuesday, January 11, by Abbott of its decision on January 7 to extend by three months after the expiration date for certain BinaxNow antigen rapid test kits that were first extended for six months in May 2021. Apply and select your preferred metal Card design: classic Platinum Card, Platinum x Kehinde Wiley, or Platinum x Julie Mehretu. As was reported last week, DHS was notified on Tuesday, January 11, by Abbott of its decision on January 7 to extend by three months the expiration date for certain BinaxNow antigen rapid test kits. - Some manufacturers have extended expiration dates. Tweezers. Terms apply to the offers listed on this page. The Centers for Disease Control and Prevention (CDC) has required a negative COVID-19 test before flying to the U.S. for all international travelers, regardless of their vaccination status, for nearly a year. It has been authorized by the FDA under an emergency use authorization. They have been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens, and are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. Editorial Disclaimer: Opinions expressed here are the authors alone, not those of any bank, credit card issuer, airlines or hotel chain, and have not been reviewed, approved or otherwise endorsed by any of these entities.