Results may be delivered in 13 minutes or less. Learn more about COVID-19 testing on ID NOW here:https://abbo.tt/3KI9smQ, BinaxNOW provides results in 15 minutes. These tests have not been FDA cleared or approved. Testing has been completed to support a shelf-life (expiration date) of up to 15 months. Expiration details by test type: ABBOTT BinaxNOW: The FDA has approved an amended EUA for Abbott BinaxNOW antigen tests, extending the effective shelf-life. You can find more information on BinaxNOW COVID-19 Ag Card and NAVICA here. D XC!mo 8sK.~?>utxnlYTCu}wtt:wic|c;?aMnkS*WI]1_/)SMU;\obw_O{5fe/+q 3"[#W9 =%y .=XW7
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BinaxNOW COVID-19 Self Tests are available at major U.S. food, drug and mass merchandiser retailers across the country. :yt8t$6;-lFh
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PDF Health Alert Network Message 21-48: Expiration Dates of Abbott BinaxNOW Learn more about COVID-19 testing on BinaxNOW here:https://abbo.tt/3hZPfNx, Our serology tests on the ARCHITECT and Alinity i systems can run up to 100-200 tests per hour. WILL YOUR RAPID TESTS BE AVAILABLE IN DRIVE-THRUS OR FOR AT-HOME USE? 3077 0 obj
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Low 33F. 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. Our lab serology blood tests running on ARCHITECT and Alinity i systems are used for the detection of antibodies, IgG and IgM, and to identify if a person was previously infected with the virus that causes COVID-19. This test has been authorized by FDA under an EUA for use by authorized laboratories. 0
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Our rapid antigen test,BinaxNOWCOVID-19 Ag Card, Home Test and Self Test allprovide results in 15 minutes. 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. 0000152529 00000 n
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Our tests are all important tools in the broader comprehensive testing effort. Many of these instruments are already located in hospital and academic medical center labs where patients go for care. h`=@^2/W2Q\%
[2x?}N8BCExT'+N Frs&41MU]/Rz{{\,O)JEgm1//Q{Z0\ve!'b@1I9\&jp,*\VALtPAew;$9gD"D-ubEn_"me*we@!jV!8&+t .}S-Fv\EZ%!ko5*axvKfsuQxU2ZM-~Z`{-Gm%ryA,=-hh5{`:*o:pcv{7MYvO%UY7yZM>q?J*QYO\tTgzO 5$~`1. 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. If you are an individual, please reach out to your healthcare provider. What if packages are exposed to temperatures outside those ranges for short periods, such as during shipping? 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. The test does not need any . Learn more.
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InteliSwab COVID-19 Rapid Test 9-month to 12-month self-life extension Since the start of the pandemic, Abbott has produced and shipped more than 2 billion COVID-19 tests. endstream
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HOW WERE YOU ABLE TO DEVELOP TESTS SO QUICKLY? Results are encrypted and available only to you and those you choose to share them with. 0000007689 00000 n
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Abbott has been a global leader in infectious disease testing for decades, having developed the world's first HIV test. gs&m0V\;IfM
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{]Tuvpnl/'|PZge~MDlegn{O:>'S9kDI#LqGTj?#]aT?!8y+vX4[{cWLh7qqrR_~ibzcDjbkU Both components, the reagent and the antibodies, start to degrade at some point, Pettengill said. 0000127178 00000 n
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It will provide a better understanding of the virus, including how long antibodies stay in the body. 0000002907 00000 n
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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 0000105492 00000 n
Afterward, they dont work as well.. )`D0cq7tLO\ &/ 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. 0000151822 00000 n
While developing an accurate and reliable test normally takes years, our expert team of scientists worked around the clock to compress the timeframe down to weeks. H\n@E^& The shelf lives for tests from some other manufacturers have been extended as well. 0000166652 00000 n
All BinaxNOW COVID-19 Ag Card Kits currently have a fifteen-month expiry date. T$ T
Your purchase was successful, and you are now logged in. Abbott also developed separate lab-based serology blood teststo detect IgM and IgG antibodies that identify if a person has been previously exposed to the virus that causes COVID. Q4{y4(L7M&e~XzhkHAj!USV{{eE =BXoZ(BMr2d+)2rElxJE:t_h_Y9e*r yP/t !N 0000016075 00000 n
Serology testing: For more information on how testing for antibodies works, check out this infographic. The systems have the ability to run high volumes of up to 470 tests in 24 hours, helping to meet the increasing demand for testing. 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. This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. The FDA has compiled a list of 23 different at-home COVID tests along with their most accurate and up-to-date expiration dates. 159 0 obj
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PDF Rapid Antigen Test Date Extensions - doh.wa.gov You have permission to edit this article. 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. This test has been authorized by FDA under an EUA for use by authorized laboratories. %%EOF
FDA Authorized BinaxNOW Expiry Extension - Long-Term Care Yes.
PDF This BinaxNOW COVID-19 Antigen Self Test has an expiration date beyond ID NOW is an FDA approved CLIA-waived instrument, which means that the technology can be used in settings outside the traditional hospital setting. o This . h2T0Pw/+Q0L)67 159 0 obj
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If you're with a hospital, lab or healthcare provider, please see the contact details below. Read more about ID NOW:https://abbo.tt/3KI9smQ hUYo8+|LPdy"PQ;^4G]yPlIY~gH9mXo|r # b4I LeHCG%F>!V 8{.4 cXXD!08En5.JQ(NFE}LzZVy9;?
Have you been stockpiling COVID test kits that are now expired? Some Hs"`S*2rT0 They are best at detecting when people are most infectious, so they know to stay home and isolate, minimizing the spread of COVID-19. And when its time to use the test, read the instructions carefully then, too. 0000126794 00000 n
At-Home OTC COVID-19 Diagnostic Tests | FDA 0000005785 00000 n
Use left/right arrows to navigate the slideshow or swipe left/right if using a mobile device, OnJan 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 testsf. We will continue to apply to FDA for shelf-life extensions every three months based on our stability studies, and the new shelf-lives for our tests will apply to tests already produced as well as future production. HOW LONG DOES IT TAKE TO GET RESULTS FOR THE ID NOW TEST? agr. The Philadelphia Inquirer (TNS), Subscriber Verification(Must be Logged In Using Free Account). Such tests which work by detecting antigens (pieces of viral proteins) on the patients swab sample will eventually expire. The U.S. Food and Drug Administration has increased the shelf life for one of the most popular at-home COVID-19 test kits. 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. Another test, called the QuickVue SARS Antigen Test, is designed to be stored at 59 to 86 degrees. With the number of cases still high, youll likely be using the test long before that date anyway. agr. This test has not been FDA cleared or approved. 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 U
Molecular tests that run on our m2000 system are already located in hospital and academic medical center labs, and reference laboratories, where patients are presenting for care.
Winds light and variable. The test is highly portable (about the size of a credit card), affordable, and provides accurate results in 15 minutes. ]bqi"w8=8YWf8}3aK
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PDF Abbott Panbio Covid-19 (NP Version) Amendment - Shelf Life Extension [!1~t8Cwvl3Skjn~4'r)eT_7Wq=*pd uzLa?H3yz|s. 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. 0000005193 00000 n
The agency typically authorizes at-home tests for four to. 0000001341 00000 n
That guidance is based on how the products were tested. We created a Global Surveillance Program 25 years ago to monitor HIV and hepatitis viruses and have a long-standing discovery program to identify new or unknown pathogens. :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 The FDA advises against using at-home Covid tests past their expiration date, because tests and their parts can break down over time. It is used on our ID NOW platform. startxref
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. We continue to work closely with our customers around the world to bring testing to where its needed most. 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. 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. 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. Our rapid antigen test, BinaxNOW COVID-19 Ag Card, Home Test and Self Test all provide results in 15 minutes. :yt8t$6;-lFh
-/WG]w;Z]uN Read more about Alinity m: https://abbo.tt/2zrt52N 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.
iHealth COVID-19 Rapid Test Kit Expiration Date Extension - iHealth Make sure youre looking at the expiration date. 0000004095 00000 n
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It can also be performed at home using a virtually guided service in partnership with eMed. Learn more. Our BinaxNOW Home Test is available through digital health provider, eMed and our BinaxNOW Self Test is available over-the-counter online and in retail stores including CVS, Walgreens and Walmart. In the case of Abbotts BinaxNOW tests, the date is printed alongside a small icon of an hourglass. To optimize results, do not use viral transport media (VTM), which could reduce the sensitivity of the test through dilution. Use the instructions to see the letter and listing of BinaxNOW COVID-19 Ag Card lots which qualify for this expiry extension. endstream
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Can You Still Use an Expired COVID Test? - health.com BinaxNOW is also a rapid test. hb```)_@( .MyG/n. 0000007821 00000 n
D 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. In August 2021, the Most of these antigen tests have a pretty good shelf life, he said. wK8 |vX@:) hUYo8+|LPdy"PQ;^4G]yPlIY~gH9mXo|r # b4I LeHCG%F>!V 8{.4 cXXD!08En5.JQ(NFE}LzZVy9;? In others, new expiration dates are posted on company websites, organized by lot number, but finding them can be a challenge. These tests have been authorized by FDA under EUAs for use by authorized laboratories and have been authorized only for the detection of nucleic acid from SARS-CoV-2 or detection of IgG antibodies against SARS-CoV-2, and not for any other viruses or pathogens. HOW ACCURATE ARE THE ID NOW COVID-19 TESTS? This test is used on our ID NOW instrument. 0000006548 00000 n
In some cases, the companies have inserted notices into the packages with the updated info. We have molecular and antigen tests that help detect an active infection of COVID-19, as well as serology tests that help detect antibodies. WHAT'S THE TURN-AROUND TIME FOR YOUR TESTS?
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The FDA has made tests available under an emergency access mechanism called an Emergency Use Authorization (EUA). H\j >w%PrNReby6l*s)do@q;@. Learn more.
Abbott BinaxNOW Expiration Dates - Long-Term Care Learn more about m2000 here: https://abbo.tt/3b8bASF, Alinity m systems have the ability to run high volumes of up to 1,080 tests in 24 hours, helping to meet the increasing demand for testing. 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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So here's how to know if your at-home test kits are still. 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 . An antibody is a protein that the body produces in the late stages of infection. endstream
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This letter is to notify you the BinaxNOW COVID-19 Ag Card, part number 195- Has your COVID rapid test expired? #cQR Low 33F. hlj@E.3AF,lKS(a2/IuwsOC"A"(H>C)DBsHshJbmBLX+XpEOr
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'hR00U8s5Bc9U+R+XhFo.AZB`08'tH 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. Learn more about all of Abbott's testing solutions to tackle the coronavirus. 0000126232 00000 n
f$Rx98|)`DHC03)7ckzUV,|$^gwHt0j eY3@54Pdkn6M8D42Z3h5E1l}^PC7B17jnhC96sBA>TtCBMEYu^tHtZSze.qT}{V5}_^Ux. Learn more about Alinity m here: https://abbo.tt/2zrt52N, ID NOW delivers positive results in as little as 5 minutes and negative results in 13 minutes. *sOi:o1_o7&}9t_bv4]S=dy*]?moi,T|*iwM1=)?uc>fX1gY%'xM^7
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Your account has been registered, and you are now logged in.
The direct swab method is the best way to ensure the test performs as expected. When the seller offers the pricing below market rates; When the seller claims that they can import iHealth tests directly from China. Learn more. 0000015990 00000 n
Submitting this form below will send a message to your email with a link to change your password. ,2NuXua+2kq'jM&e:MO_>{%yw4g{9vp:am+#E?&F%*(h[iE+[x~_]N2IZNr-]N^^v)j$QN/7_8#9tE'nrM^M'N3u~*vaBgb2)zU{ eu
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The agency announced that Abbott's BinaxNow COVID-19 Ag Card Home Test is now approved for a 15-month expiration window. This test has not been FDA cleared or approved.
Has Your COVID Test Really Expired? - webmd.com Most of our tests may be available through your healthcare provider or at retail pharmacies. hXnF}L
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h2T0Pw/+Q0L)67 If you're with a hospital, lab, or healthcare provider, you can contact us for questions about ID NOW here. 0000006042 00000 n
:x$eh https://abbott.mediaroom.com/2020-10-12-Abbott-Receives-FDA-Emergency-Use-Authorization-for-its-COVID-19-IgM-Antibody-Blood-Test. Our antibody and molecular lab tests are available around the world, as well as our ID NOW rapid molecular test. For more information on the Alinityi system, check out this news release: https://abbo.tt/2SWCvtU An email message containing instructions on how to reset your password has been sent to the e-mail address listed on your account. 0000001630 00000 n
Press the space key then arrow keys to make a selection. This letter is to notify you the BinaxNOW COVID-19 Ag Card, part number 195- 000, in your possession may now have a longer than labeled product expiry date. HVMo8W(CR(E&i]4E A clear sky. 0000008006 00000 n
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ID NOW is a lightweight and portable instrument (the size of a toaster), that allows testing to occur near the patient to get rapid molecular results including physicians' offices, urgent care settings, and hospital emergency departments.
Tests with thisprinted Nowhave extended expiration date (Year-Month-Day) pR N_q :l@\/9`ho}.M^:nYu_x);|!WCyP#$U1M6 qht
'hR00U8s5Bc9U+R+XhFo.AZB`08'tH Start your subscription for just $5 for 3 months Subscribe. Ourm2000 and Alinity m molecular systems are used in hospital and lab settings that are testing high volumes. Choose wisely! Testing has been completed to support a shelf-life (expiration date) of up to 15 months. Press release announcing launch of the ID NOW COVID-19 test here.
This follows a request by the company to provide a longer shelf life for its test, after it reported stability studies that showed the tests remained . %%EOF
Learn more about ARCHITECT here: https://abbo.tt/3abd0eq, Learn more about Alinity i here: https://abbo.tt/2SWCvtU.
International travelers catch a break as FDA extends expiration date Please be aware that the website you have requested is intended for the residents of a particular country or region, as noted on that site. Get up-to-the-minute news sent straight to your device. Fx J+-'[^(0V*JCIZ$V.$?gS,|6 FgRQ4:Gh#^zKgmyE1VQz^}[|(>wiqp_wWPOztK=z|1w|35_,NK#uYapFYsr2V)o;lQi9}w|1IY\6v0Ok!o+E./8?
/[&%x~@!O'6)1"42qY87*2DI+r Please disable your ad blocker, whitelist our site, or purchase a subscription. Generally, the FDA authorizes at-home test kits with a shelf life of about four to six months, but that shelf life could be extended if the manufacturer finds more data that shows the tests are. !}TO'Y7@O/+Ol&i5`W]bq0!nA^C>VKjMp:J}C a:!F ID NOW is a lightweight and portable instrument (just 6.6 pounds and the size of a toaster) that allows testing to occur near the patient to get rapid results including in physicians' offices, urgent care settings, and hospital emergency departments. f$Rx98|)`DHC03)7ckzUV,|$^gwHt0j eY3@54Pdkn6M8D42Z3h5E1l}^PC7B17jnhC96sBA>TtCBMEYu^tHtZSze.qT}{V5}_^Ux. 0000105677 00000 n
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This test is used on our ID NOW instrument. CHECK OUT THESE HELPFUL LINKS. But the manufacturer, Abbott, obtained. The iHealth COVID-19 Antigen Rapid Test, for examplethe one sent . H\j0~ 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.
Abbott Diagnostics Scarborough, Inc.: BinaxNOW COVID-19 Ag Self Test o Abbott Panbio COVID -19 AG Rapid Test Device (nasal) (December 31, 2020) . <<6E9C363DB97F0F4FA676E3E40C7FF57B>]/Prev 190041/XRefStm 1630>>
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WHAT TESTS DO YOU HAVE FOR DETECTING COVID-19? HOW LONG HAS THE ID NOW INSTRUMENT BEEN IN USE? 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{` 0000010349 00000 n
Molecular testing: Take a look at this infographic on how coronavirus molecular testing works.
Abbott announces expiration extensions for BinaxNOW tests Your Expired COVID Test Kits Might Still Be Good. Here's How to Find The ID NOW COVID-19 test is a rapid, molecular point-of-care test that detects COVID-19 in 13 minutes or less. The test does not need any additional equipment. It can be self-administered at home, performed by healthcare professionals at the point-of-care, or it can be used at home with a virtually guided collection and testing process in partnership with eMed, an online digital health service, making it an important tool to diagnose COVID-19. For more information on ID NOW check out this article: https://abbo.tt/2UT36cN.
2021, Health Canada authorized an amendment for a shelf life extension from 12 to 24 months. 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. In some cases, the expiration date for a test may be extended. Your e-mail address will be used to confirm your account. 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. They are still fine, according to WHEC, the NBC affiliate in chilly Rochester, New York, which posed that question to manufacturers.
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. R, Click on the bell icon to manage your notifications at any time. ,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
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 HOW DO YOU PERFORM AN ID NOW COVID-19 TEST? A single at-home COVID-19 test by Quidel sits on a drugstore shelf on Sept. 14, 2021, in Chicago. 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. To be on the safe side, use a test that has not expired.
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. Rapid antigen tests offer several important benefits. hb```&.Ad`0p`2oPr`FB62p40t 4n>(f`df
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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 U
Read more about Alinity i: https://abbo.tt/2SWCvtU Our first molecular test is used on our lab-based molecular instrument, m2000. hb```b``a`c`bb@ !V da ^Tf0ierg B
AA!/SZ11K>KK 8K'6Un7',. 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. For more information on ID NOW check out this article: https://abbo.tt/2UT36cN. T$ T
: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 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. 5qy_MkmBVBv.e:aIQn O/f%Sok^kVs>pbZrP}`J{bO]^WS|*wKcaC i+d*>e/NiW. 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.