Celltrion DiaTrust COVID-19 Ag Home Test, 2 Tests Per Pack, FDA EUA Authorized Multiple Target OTC Test, Result in 15 Minutes Without Sending to a Lab
What are celltrion diatrust covid-19 ag home test features?
- Make sure this fits by entering your model number.
- Shelf-life extension: our tests sold from amazon has 6 months longer shelf-life than the printed expiration date on the package. Fda granted 6 months shelf-life extension for the celltrion diatrust covid-19 ag home test, which extended the shelf life from 12 months to 18 months as of may 20th, 2022. The affected lot numbers can be found on fda’s website: https://www.fda.gov/media/159236/download
- Fda eua-authorized home test (otc): celltrion diatrust covid-19 ag home test is an fda eua-authorized covid-19 rapid antigen at-home testing kit. Self-test in the comfort of your own home, and get the relief you need, fast. For use in individuals aged 14 years and older.
- Two tests per kit: each kit contains supplies for two tests: swabs, test devices, test tubes (extraction buffer), filter caps, and an instructions for use manual. Test tubes and filter caps for two tests are enclosed in one inner package.
- Rapid results and percentage: the test gives you results in just 15 minutes and is authorized for at-home use without submitting sample collection to labs. Our home test is capable of detecting covid-19 with 99.8% negative percent agreement and 86.7% positive percent agreement.
- Simple steps: just four steps from start to finish. The diatrust system makes getting your results easy. Detailed instruction is enclosed with the product and video instruction is available on both our product page and website. Test yourself and a family member at the same time or take two tests in a designated timeframe for travel, work, and more.
- Swab with softness: our products prioritize user comfort, utilizing flock swabs with a softer tip that doesn’t irritate your nasal passages.
Product guides and documents
Celltrion DiaTrust COVID-19 Ag Home Test, 2 Tests Per Pack, FDA EUA Authorized Multiple Target OTC Test, Result in 15 Minutes Without Sending to a Lab AMAZON
Looking for specific info?
Wasn’t this celltrion covid test recently recalled? Why is amazon still selling?
The celltrion diatrust covid-19 ag home test was not subject to the recall by the fda. The tests which were recalled were unauthorized celltrion diatrust covid-19 ag rapid tests from celltrion healthcare, which were not authorized for use in the us market.
Per the fda safety communication: ‘the celltrion diatrust covid-19 ag home test, from celltrion usa, inc., was authorized by the fda on october 21, 2021 for home use. These tests are not affected by this safety communication and can continue to be used. The celltrion diatrust covid-19 ag rapid test, from celltrion usa, inc., was authorized by the fda on april 16, 2021, for point-of-care use, such as in health clinics. These tests are not the subject of this safety communication and can continue to be used.’
How accurate is it?
How deep should the sterile swab be inserted into the nostrils?
1) how long is the shelf life of these tests? 2) where are they produced? 3) is the use of an app required for results (or, how are results obtained)?
2) the test is made in south korea.
3) the use of the app is not required as the results can be directly read from the test. Please refer to the instructions of use for exact instructions on how to interpret the results.
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Isn’t it discouraged to use by the fda?
– recalled product (for poc): celltrion diatrust covid19 ag ‘rapid’ test
– current product (for otc): celltrion diatrust covid-19 ag ‘home’ test
Is this product registered (authorized) by fda?
So, you can find the name of this product in fda’s eua list.
Https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2
What is the date of the product found on the back of the box or on the back of the aluminum pouch for the test device and extraction buffer?
Were these made in china?
How do i store unused celltrion diatrusttm covid-19 ag home tests?
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What is the shelf life for this test?
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What should i do if my celltrion diatrusttm covid-19 ag home test result is negative?
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How is the celltrion diatrusttm covid-19 ag home test different from a conventional lab-based pcr test?
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Why does the app say the test i just bought is not valid?
If the app still says not valid after manual typing, please contact celltrion usa customer service (celltrionusa.cs@celltrion.com) for replacement.
Screen captured image (including invalid serial number) of the “invalid test” is required in order to be considered for product replacement.
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How do i get results in an electronic format, such as a pdf, to show airports and other officials?
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Is this test approved for use for travel to jamaica and back into the us?
For below answer by other user, correct information needs to be added.
Fda recalled the different product (for poc, which is performed by healthcare provider), not this product.
– recalled product (for poc): celltrion diatrust covid19 ag ‘rapid’ test
– current product (for otc): celltrion diatrust covid-19 ag ‘home’ test
Is this acceptable to meet airline requirements for returning to us after trip?
Is there a recall on these tests?
The celltrion diatrust covid-19 ag home test sold on amazon is not subject to any fda recalls. Amazon had mistakenly sent a recall notification in error. This was addressed by amazon on the same week, in the following email sent by the amazon.com team:
dear amazon customer,
you recently received the following recall notification in error:
https://www.fda.gov/medical-devices/medical-device-recalls/celltrion-usa-recalls-certain-point-care-celltrion-diatrust-covid-19-ag-rapid-tests-false-positive
due to this, we urge you to disregard the previous recall notification.
B09m7gkccb – celltrion diatrust covid-19 ag home test, 2 tests per pack, fda eua authorized multiple target otc test, result in 15 minutes without sending to a lab sold on amazon.com is not subject to recall by the fda or celltrion usa.
The safety and satisfaction of our customers is our highest priority. We regret any inconvenience this may cause you.
Sincerely,
customer service
amazon
Does this require a smartphone to use?
Should i collect the specimens from both sides of nostrils?
Why does this test have so many false negatives? I bought it for my son and it falsely told me both times he was negative.
Fda recalled the different product (for poc, which is performed by healthcare provider), not this product.
– recalled product (for poc): celltrion diatrust covid19 ag ‘rapid’ test
– current product (for otc): celltrion diatrust covid-19 ag ‘home’ test
Celltrion DiaTrust COVID-19 Ag Home Test, 2 Tests Per Pack, FDA EUA Authorized Multiple Target OTC Test, Result in 15 Minutes Without Sending to a Lab AMAZON
What are our customers saying?
Important informationDirections
Directions
Individuals aged 14 years and older
Legal Disclaimer
The Celltrion DiaTrust™ COVID-19 Ag Home Test is for use under Emergency Use Authorization (EUA) only. This test has not been FDA cleared or approved. This test has been authorized by FDA under EUA. This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of this test 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. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner. Please find more information in our privacy policy in the link here: http://diatrustcovid.com/assets/pdfs/privacy_policy_DiaTrust_Ver.1.01.pdf