DiaTrust™ At-Home OTC COVID-19 Test
Rapid Antigen At-Home Self Test approved for Over-The-Counter sales.
|Country of Origin||South Korea|
|Application||Rapid Test Kit – Self Test|
|Contents||(2) Test Devices, (2) Extraction Reagent Capsules, (2) Sterile Swabs, Package Insert, Quick Reference Instruction For Use|
|Number of Tests||2 Tests|
|Test Format||Test Device|
|Test Method||Lateral Flow Immunochromatographic Assay|
|Test Type||Rapid Antigen Detection|
|Time to Results||15 Minute Results|
|Kit Packing||2 Tests|
|Case Packing||60 Kits (120 Tests)|
|Application||At-Home OTC COVID-19 Test|
|Pallet Packing||16 cases (1,920 tests) – Stack 2 pallets (3,840 tests / stack)|
- 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
- 12 Month Shelf Life
- 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. For use under the Emergency Use Authorization (EUA) only. This product has not been FDA cleared nor approved but has been authorized by the FDA under an EUA.
- 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.
- Individuals should provide all results obtained with this product to their healthcare provider for public health reporting
- This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens