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Celltrion DiaTrust™ COVID-19 Antigen Rapid Test, 2 Tests per Pack

Now: $12.90
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SKU:
DIATRUST-1-1
UPC:
806121763235
Condition:
New
Availability:
Ships from stock from our warehouse in New York.
Lead/Fulfillment Time:
in stock
Ships From:
Mount Vernon, NY
For Quotes Over 1,000:
email bill@ballchain.com or call 914 720 3164
                                                                                                                                      

Each Box Contains 2 Tests.

The Celltrion DiaTrust™ COVID-19 Ag Home Test is for use under Emergency Use Authorization (EUA) only. This product has not been FDA cleared or approved but
has been authorized by FDA under an 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 product 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 sooneDetects active COVID-19 infection in 10 minutes.
 

Intended Use

The Celltrion DiaTrust™ COVID-19 Ag Home Test is a lateral flow immunoas-say intended for the qualitative detection of nucleocapsid protein and receptor-binding domain (RBD) of the SARS-CoV-2 spike proteins in mid-turbinate swabs from the SARS-CoV-2. This test is authorized for non-prescription home use with self-collected and adult-collected direct mid-turbinate swab samples from individuals aged 14 years or older with symptoms of COVID-19 within the first seven days of symptom onset.

This test is also authorized for non-prescription home use with self-collected and adult-collected mid-turbinate swab samples from individuals 14 years or older with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over three days for at least 24 hours (and no more than 48 hours) between tests. 

1. For use under the Emergency Use Authorization (EUA) only.

2. For in vitro diagnostic use. 

 

How to use.

1. Swirl the swab in your nasal to collect a sample.

2. Put the tip of the swab into the test tube, mix the sample and the buffer fluid thoroughly.

3. Put the filter cap and dispense 3 drops into the sample well.

4. Read the result after 15 minutes.
Do not read results after 20 minutes.

Storage & Stability

Only open the aluminum pouch when you are ready to do the test. Immediately perform the test after opening the pouch. An unopened test device should be stored at 2 - 30°C (36 - 86°F). If the tests were refrigerated, keep them at room temperature for 30 minutes prior to use. It is stable until the expiration date is marked on the label. 

 

Made in the USA.

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