Get up-to-the-minute news sent straight to your device. The FDA advises against using at-home Covid tests past their expiration date, because tests and their parts can break down over time. To be on the safe side, use a test that has not expired. Molecular testing: Take a look at this infographic on how coronavirus molecular testing works. 109 0 obj
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Many of these instruments are already located in hospital and academic medical center labs where patients go for care. hlj@E.3AF,lKS(a2/IuwsOC"A"(H>C)DBsHshJbmBLX+XpEOr f$Rx98|)`DHC03)7ckzUV,|$^gwHt0j eY3@54Pdkn6M8D42Z3h5E1l}^PC7B17jnhC96sBA>TtCBMEYu^tHtZSze.qT}{V5}_^Ux. It can also be performed at home using a virtually guided service in partnership with eMed. 0000166958 00000 n
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h2T0Pw/+Q0L)67 This article helps explain how the ID NOW molecular point-of-care test for COVID-19 works. 109 51
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Generally, the FDA authorizes at-home test kits with a shelf life of about four to six months, but that shelf life could be extended if the manufacturer finds more data that shows the tests are. The shelf lives for tests from some other manufacturers have been extended as well. Press release announcing launch of the ID NOW COVID-19 test here. These tests have not been FDA cleared or approved. Ourm2000 and Alinity m molecular systems are used in hospital and lab settings that are testing high volumes. The test does not need any . This is the name that will be displayed next to your photo for comments, blog posts, and more. Abbott received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the ID NOW COVID-19 test in March 2020. ? Your e-mail address will be used to confirm your account. We are producing 50,000 COVID-19 tests a day for our ID NOW system. We, iHealth Labs Inc, hereby clarify that we and our authorized distributors are the only organizations in the U.S. that may legally sell and distribute the Kit under FDA EUA. Facilities should keep a copy of the referenced document for any % 0000004068 00000 n
iHealth Rapid . As a result, the site may contain information on pharmaceuticals, medical devices and other products or uses of those products that are not approved in other countries or regions. A clear sky. Learn more. WILL YOUR RAPID TESTS BE AVAILABLE IN DRIVE-THRUS OR FOR AT-HOME USE? kdv1_2x/ We have always made highly reliable and accurate tests for other infectious diseases such as HIV and hepatitis, and we're highly confident in our tests since weve used the same approach to development. HOW LONG DOES IT TAKE TO GET RESULTS FOR THE ID NOW TEST? Our antibody and molecular lab tests are available around the world, as well as our ID NOW rapid molecular test. Biolabs International LLC / GriffMaier LLC, Paramount Sourcing LLC (exclusively partnered with Office Depot), Sunshine Paper LLC / Marketing Promotion Image Inc. 0000013781 00000 n
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. This how-to video also helps explain how molecular point-of-care testing on ID NOW works. Currently, the ID NOW COVID-19 test is available only in the U.S. under emergency use authorization (EUA) as this is where the majority of our ID NOW instruments are in use today. Learn more about COVID-19 testing on ID NOW here:https://abbo.tt/3KI9smQ, BinaxNOW provides results in 15 minutes. The EUA is supported by the Secretary of Health and Human Services' declaration that circumstances exist to justify the development of in vitro diagnostics (IVDs) under EUA for the detection and/or diagnosis of 2019-nCoV. %%EOF
Learn more. The website that you have requested also may not be optimized for your screen size. 0000002907 00000 n
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/[&%x~@!O'6)1"42qY87*2DI+r expiration date (Year-Month-Day) Abbott Diagnostics Scarborough, Inc.: BinaxNOW COVID-19 Ag Self Test 15-month to 22-month shelf-life extension granted by the FDA December 21, 2022 ECRI, a Plymouth Meeting-based nonprofit that evaluates the safety and quality of health care, recently ranked seven common tests on their user-friendliness, at www. It will provide a better understanding of the virus, including how long antibodies stay in the body. If you're with a hospital, lab, or healthcare provider, you can contact us for questions about ID NOW here. OraSure Technologies, Inc.: InteliSwab COVID-19 Rapid Test 9-month to 12-month self-life extension granted by the FDA August 3, 2022 Lot Number Tests with this printed expiration date (Year-month-day) 0000001804 00000 n
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. endstream
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For more information on Alinity m, check out this news release: https://abbo.tt/2zrt52N, Our rapid, molecular point-of-care test detects COVID-19 in 13 minutes or less. The website you have requested also may not be optimized for your specific screen size. It may seem obvious, but read the instructions. 0000105562 00000 n
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But for certain tests, that expiration date may have been extended beyond what is stamped on the package provided the manufacturer has demonstrated to the FDA that the components remain stable. If you're with a hospital, lab or healthcare provider, please see the contact details below. a This test has not been FDA cleared or approved. 864 0 obj
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An extended expiration date means the manufacturer provided. 0000127178 00000 n
HVMo8W(CR(E&i]4E Were continuing to ramp up our ID NOW manufacturing and plan to increase capacity to 2 million tests a month by June and are working to expand beyond that. Our tests are all important tools in the broader comprehensive testing effort. Clinicians and lab professionals have been using the same ID NOW instrument, collection swabs, and consumables (such as the sample receiver and transfer cartridge) to safely test respiratory viruses during this time. hb```)_@( .MyG/n. 0000126232 00000 n
HOW WERE YOU ABLE TO DEVELOP TESTS SO QUICKLY? The iHealth COVID-19 Antigen Rapid Test, for examplethe one sent . 0000007689 00000 n
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ID NOW is a lightweight and portable instrument (just 6.6 pounds and the size of a toaster) that allows testing to occur near the patient to get rapid results including in physicians' offices, urgent care settings, and hospital emergency departments. Testing has been completed to support a shelf-life (expiration date) of up to 9 months from Date of Manufacture. Data transmitted in the app is encrypted and users only share name, birthdate, phone number, zip code and email address which is used for creating your personal profile in the app. To find out if your. pR N_q :l@\/9`ho}.M^:nYu_x);|!WCyP#$U1M6 qht
'hR00U8s5Bc9U+R+XhFo.AZB`08'tH Most of our tests may be available through your healthcare provider or at retail pharmacies. 159 0 obj
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Submitting this form below will send a message to your email with a link to change your password. endstream
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The FDA has compiled a list of 23 different at-home COVID tests along with their most accurate and up-to-date expiration dates. wK8 |vX@:) 159 0 obj
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Expiration details by test type: ABBOTT BinaxNOW: The FDA has approved an amended EUA for Abbott BinaxNOW antigen tests, extending the effective shelf-life. If you are an individual, please reach out to your healthcare provider. !}TO'Y7@O/+Ol&i5`W]bq0!nA^C>VKjMp:J}C a:!F Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. Theyre pretty stable for over a year.. Read more about BinaxNOW COVID-19 Ag Card:https://abbo.tt/3hZPfNx. Our rapid, molecular point-of-care test detects COVID-19 in 13 minutes or less. We continue to work closely with our customers around the world to bring testing to where its needed most. Low 33F. Results are encrypted and available only to you and those you choose to share them with. Results may be delivered in 13 minutes or less. What if packages are exposed to temperatures outside those ranges for short periods, such as during shipping? HOW DO I KNOW IF I NEED TO SEEK OUT ONE OF YOUR TESTS? Learn more about Alinity m here: https://abbo.tt/2zrt52N, ID NOW delivers positive results in as little as 5 minutes and negative results in 13 minutes. Organizations like employers and schools have the option to use the app to view and verify the information on a mobile device to facilitate safer entry into facilities along with hand-washing, social distancing, enhanced cleaning and mask-wearing. %PDF-1.7 Page 1 of 4 Abbott Diagnostics Scarborough, Inc.: BinaxNOW COVID -19 Ag Card Home Test 12-month to 15-month shelf-life extension granted by the FDA on January 7, 2022 endstream
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Abbott and the regulatory approval of Panbio Covid-19 Version NP test Abbott is an American company that holds 365 medical device licenses in Canada under 19 . 3130 0 obj
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Learn more about all of Abbott's testing solutions to tackle the coronavirus. #cQR Abbott is providing these links to you only as a convenience, and the inclusion of any link does not imply endorsement of the linked site by Abbott. endstream
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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 of Baptist Health Floyd Hospital in New Albany, Indiana. 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. Abbott says its tests can be stored between 36 to 86 degrees Fahrenheit, but that the kits should be at room temperature at the time they are used. They are best at detecting when people are most infectious, so they know to stay home and isolate, minimizing the spread of COVID-19. CHECK OUT THESE HELPFUL LINKS. U
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Its really no different than when your medications expire, Volk said. The first-of-its-kind app, available at no charge, allows people who test negative to get a temporary digital health pass that's renewed each time the person has a negative test. 0000003892 00000 n
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Press the space key then arrow keys to make a selection. It can be used at home, by healthcare professionals at the point-of-care and or at home using a virtually guided service for the detection of antigens that form in the early stage of active infections. ,2NuXua+2kq'jM&e:MO_>{%yw4g{9vp:am+#E?&F%*(h[iE+[x~_]N2IZNr-]N^^v)j$QN/7_8#9tE'nrM^M'N3u~*vaBgb2)zU{ eu
But the manufacturer, Abbott, obtained a three-month extension on the expiration date after supplying additional data to the FDA. ID NOW is a lightweight and portable instrument (the size of a toaster), that allows testing to occur near the patient to get rapid molecular results including physicians' offices, urgent care settings, and hospital emergency departments. endstream
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For more information on ID NOW check out this article: https://abbo.tt/2UT36cN. For more information on ID NOW check out this article: https://abbo.tt/2UT36cN. 0000014860 00000 n
Charles Passy President Biden is ending the country's COVID emergency declaration, which means Americans may no longer get free tests. Q4{y4(L7M&e~XzhkHAj!USV{{eE =BXoZ(BMr2d+)2rElxJE:t_h_Y9e*r yP/t !N "Ds>f`bdd100"M`
Links which take you out of Abbott worldwide websites are not under the control of Abbott, and Abbott is not responsible for the contents of any such site or any further links from such site. 0000001341 00000 n
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Since the launch of the ID NOW COVID-19 test kit, Abbott has continued testing for product stability to extend the expiration date and have shared these results with the FDA. For more information on our ARCHITECT antibody test, check out this article: https://abbo.tt/3abd0eq {]Tuvpnl/'|PZge~MDlegn{O:>'S9kDI#LqGTj?#]aT?!8y+vX4[{cWLh7qqrR_~ibzcDjbkU 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. They are not all the same, and they can be confusing. Your account has been registered, and you are now logged in. Another test, called the QuickVue SARS Antigen Test, is designed to be stored at 59 to 86 degrees. 0000020161 00000 n
The Philadelphia Inquirer (TNS), Subscriber Verification(Must be Logged In Using Free Account). !.ObGl]q MnK#Xp;E,Z,HM\VYw|:aP+: Make sure youre looking at the expiration date. For more information on the Alinityi system, check out this news release: https://abbo.tt/2SWCvtU It can be used in three different ways. BinaxNOW is also a rapid test. HOW ACCURATE ARE THE ID NOW COVID-19 TESTS? The test is highly portable (about the size of a credit card), affordable, and provides accurate results in 15 minutes. Such tests which work by detecting antigens (pieces of viral proteins) on the patients swab sample will eventually expire. 0000009168 00000 n
This type of knowledge could help support research about how the virus spreads within communities and immune responses to vaccines. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. x]>q"%>Ip]=i>lMn'l2I,nfgMKIS|(|_^}_Cg=~WW/^{xx/^|W=5m_~r3{2trS~S[7{iOo5OWo?O4j-te/m.Ue6~w|7~y~8]Mo^s?_;95qf{aKqrKx-yc|.?]nK{F;knC{a5OUH{` Our first molecular test is used on our lab-based molecular instrument, m2000. :x$eh Antigen tests detect proteins of the SARS-CoV-2 virus that form during the infection cycle and indicate that a person has an active infection. ID NOW has been in use since 2014 to detect flu, strep, and RSV. HOW DO YOU PERFORM AN ID NOW COVID-19 TEST? Abbott Diagnostics Scarborough, Inc. 10 Southgate Road Scarborough, ME 04074 Re: EUA210264/5003 Trade/Device Name: BinaxNOW COVID-19 Antigen SelfTest Dated: December 27, 2021 Received: December 27, 202 1 Dear Ms. Drysdale: This is to notify you that your request to; (1) update the shelf-life expiration date of the BinaxNOW COVID-19 Ag 0000006042 00000 n
More than 800,000 rapid COVID-19 tests passed their expiration date recently in a Florida warehouse, prompting concerns that they would go to waste. "An extended expiration date means the manufacturer provided data showing that the shelf-life is longer than was known when the test was first authorized," the FDA says. :C1lr"wiUog-+Wu4W_*_EVqX~/,Lgj>Am=1-ij [)l+vr}H\b5&k?~s?YJgX?9n/t(8,?zzIc^|vxH>_{$HH>X{F)"y$sDmA=Jd:"'Vvu;;iX[g 0000152529 00000 n
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[!1~t8Cwvl3Skjn~4'r)eT_7Wq=*pd uzLa?H3yz|s. This letter is to notify you the BinaxNOW COVID-19 Ag Card, part number 195- 000, in your possession may now have a longer than labeled product expiry date. The agency announced that Abbott's BinaxNow COVID-19 Ag Card Home Test is now approved for a 15-month expiration window. Sign up to receive news and updates from this site directly to your desktop. When the seller offers the pricing below market rates; When the seller claims that they can import iHealth tests directly from China. Your purchase was successful, and you are now logged in. Choose wisely! 0000000016 00000 n
WHAT TESTS DO YOU HAVE FOR DETECTING COVID-19? Choosing a selection results in a full page refresh. 0000001630 00000 n
IS THERE ANY RISK OF CONTAMINATION FOR LAB WORKERS WHO ARE OPERATING ID NOW? %%EOF
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. The expiration date is set at the end of the shelf-life. For more information on our IgM antibody test, check out this news release: https://abbott.mediaroom.com/2020-10-12-Abbott-Receives-FDA-Emergency-Use-Authorization-for-its-COVID-19-IgM-Antibody-Blood-Test. 0000012590 00000 n
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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 . But stick to the recommended temperatures as much as possible. But the exact date in each case is an open question, in part because some of the manufacturers are new at this game. Also, our manufacturer will NOT supply to any other organizations in the U.S. except for iHealth Labs Inc. 0
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The expiration dates of the lot numbers listed in the referenced link have been extended to 12 months. hXnF}L
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Generally, the tests are designed to be stable at a wide range of temperatures. They are highly portable, scalable, easy-to-use and provide a flexible approach to helping more people in more places get access to reliable testing in a cost effective way. The website you have requested also may not be optimized for your specific screen size. There are a variety of different tests being deployed and a whole ecosystem is needed to support testing in different healthcare settings. 3097 0 obj
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HOW DOES EMERGENCY USE AUTHORIZATION (EUA) SUBMISSION PROCESS WORK? We won't share it with anyone else. 0000016075 00000 n
Abbott has been a global leader in infectious disease testing for decades, having developed the world's first HIV test. It has come to our attention that there is some false information regarding the price of iHealth Covid-19 Antigen Rapid Test (the "Kit") in the U.S. market. Low 33F. The tests are available on our ARCHITECT and Alinityi systems. To optimize results, do not use viral transport media (VTM), which could reduce the sensitivity of the test through dilution. 3077 0 obj
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The ID NOW instrument uses molecular technology and molecular tests in general are valued for their high level of accuracy in similar settings such as flu testing. Use the instructions to see the letter and listing of BinaxNOW COVID-19 Ag Card lots which qualify for this expiry extension. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company. hb```&.Ad`0p`2oPr`FB62p40t 4n>(f`df
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R, For our rapid antigen tests, BinaxNOW is available in the U.S. and Panbio is available in many countries outside of the U.S. They wont go bad the very day of the printed expiration date, but eventually the accuracy of the test may start to decline. o Abbott Panbio COVID -19 AG Rapid Test Device (nasal) (December 31, 2020) . Click here for more info: https://abbo.tt/2X7xwZo, Please check the CDC resources on how to protect yourself and what to do if you think you are sick: https://abbo.tt/3hJSINd, Learn more about Abbott's approach to tackling the coronavirus: https://abbo.tt/2WHMDco 0000002428 00000 n
We have molecular and antigen tests that help detect an active infection of COVID-19, as well as serology tests that help detect antibodies. ID NOW is an FDA approved CLIA-waived instrument, which means that the technology can be used in settings outside the traditional hospital setting. Has your COVID rapid test expired? 0
We have developed twelve tests for COVID-19 globally. Our ID NOW molecular point-of-care test met all testing criteria in the FDA's emergency use authorization (EUA) and were continuing to collect more clinical data in the field. 0000105492 00000 n
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agr. If you forget it, you'll be able to recover it using your email address. :C1lr"wiUog-+Wu4W_*_EVqX~/,Lgj>Am=1-ij [)l+vr}H\b5&k?~s?YJgX?9n/t(8,?zzIc^|vxH>_{$HH>X{F)"y$sDmA=Jd:"'Vvu;;iX[g And when its time to use the test, read the instructions carefully then, too. pR N_q :l@\/9`ho}.M^:nYu_x);|!WCyP#$U1M6 qht
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Since the start of the pandemic, Abbott has produced and shipped more than 2 billion COVID-19 tests. Both components, the reagent and the antibodies, start to degrade at some point, Pettengill said. iHealth Rapid . Please be aware that the website you have requested is intended for the residents of a particular country or region, as noted on that site. Please be aware that the website you have requested is intended for the residents of a particular country or region, as noted on that site. Even Abbott, which has years of experience making similar tests for other purposes, has extended the expiration dates on its COVID tests several times, after demonstrating that the components remain stable. Most of these antigen tests have a pretty good shelf life, he said. 0000126767 00000 n
In others, new expiration dates are posted on company websites, organized by lot number, but finding them can be a challenge. Read more about m2000: https://abbo.tt/2U1WMiU 0000015990 00000 n
They are still fine, according to WHEC, the NBC affiliate in chilly Rochester, New York, which posed that question to manufacturers. trailer
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Since the U.S. Centers for Disease Control and Prevention began allowing inbound travelers to fly into the United States with a negative result from an at-home instant COVID-19 test in May, just two tests have been approved for use Abbott's BinaxNow COVID-19 Home Test and Ellume's COVID-19 Home Test.. On Oct. 1, Ellume voluntarily recalled more than 2 million tests, citing "higher-than . This test is used on our ID NOW instrument. In some cases, the companies have inserted notices into the packages with the updated info. 1899 0 obj <>stream Abbott is providing these links to you only as a convenience, and the inclusion of any link does not imply endorsement of the linked site by Abbott. D H\n@E^& With the number of cases still high, youll likely be using the test long before that date anyway. BinaxNOW COVID-19 Self Tests are available at major U.S. food, drug and mass merchandiser retailers across the country. 0000004942 00000 n
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Posted on 11/05/2021 You can access the most information related to Abbott of BinaxNOW tests that have been authorized to have their expiration dates extended by accessing information directly from Abbott's website. The type of Abbott tests in the Florida warehouse are now deemed to have a shelf life of 15 months, up from 12. Expiration Date Extension by Dingchao Liao February 13, 2023 On Jan 11, 2023, the FDA granted another three-month shelf-life extension for the iHealth COVID-19 Antigen Rapid Test, which extended the shelf-life of all iHealth tests from 6 months to 15 months. endstream
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Expiration details by test type: ABBOTT BinaxNOW: The FDA has approved an amended EUA for Abbott BinaxNOW antigen tests, extending the effective shelf-life. Read more about Alinity i: https://abbo.tt/2SWCvtU <<6E9C363DB97F0F4FA676E3E40C7FF57B>]/Prev 190041/XRefStm 1630>>
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https://abbott.mediaroom.com/2020-10-12-Abbott-Receives-FDA-Emergency-Use-Authorization-for-its-COVID-19-IgM-Antibody-Blood-Test. X@6G02Sg3A O2\nl\Lfr,bM,29>k"gcz+7 ?|Rb. For more information on m2000, check out this article: https://abbo.tt/2U1WMiU, We also have a molecular test for our Alinity m system under the FDA's Emergency Use Authorization. Learn more about ARCHITECT here: https://abbo.tt/3abd0eq, Learn more about Alinity i here: https://abbo.tt/2SWCvtU. Please disable your ad blocker, whitelist our site, or purchase a subscription. Here's how to tell, By Tom Avril But the manufacturer, Abbott, obtained. This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.