DiaTrust™ COVID-19 25pk Rapid Antigen At-Home Self Test approved for Over-The-Counter sales. Smart Phone APP Tech-Enabled Health Pass Included.
| Country of Origin | South Korea |
| Application | Rapid Test Kit – Self Test |
| Contents | (25) Test Devices, (25) Extraction Reagent Capsules, (25) Sterile Swabs, (1) Quick Reference Instruction For Use |
| Number of Tests | 25 Tests |
| Storage | Room Temperature |
| Test Format | Test Device |
| Test Method | Lateral Flow Immunochromatographic Assay |
| SKU | CT-P60-D2-05-25 |
| Test Type | Rapid Antigen Detection |
| Time to Results | 15 Minute Results |
| Kit Packing | 25 Tests |
| Case Packing | 60 Kits (120 Tests) |
| Application | At-Home OTC COVID-19 Test |
| Pallet Packing | 8 cases (4,800 tests / 192 kits) – Stack 2 pallets (9,600 tests / stack) |
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- For Use Under an Emergency Use Authorization (EUA) Only: 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
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- 12 Month Shelf Life
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- The DiaTrust™ At-Home OTC COVID-19 Test is intended for the qualitative detection of nucleocapsid proteins from SARS-CoV-2 from individuals with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 36 hours between tests
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- This test is authorized for nonprescription home use with self-collected (unobserved) direct mid nasal(NS) swab specimens from individuals aged 14 years and older
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- Individuals should provide all results obtained with this product to their healthcare provider for public health reporting
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- This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens
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- The test is intended to be read at 15 minutes (Sample-to-answer time: 15 mins); If the test is read before this or is read more than 5 minutes after the indicated read time, results may be inaccurate and the test should be repeated
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- Sample Type: Direct Mid-Turbinate Swab Samples
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- 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 sooner.
