Celltrion DiaTrust™ At-Home OTC COVID-19 Test – 2ct


Celltrion DiaTrust™ COVID-19 Ag Home Test (OTC) is a lateral flow immunoassay 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 product has not been FDA cleared nor approved but has been authorized by the FDA under an EUA.

Sample Type: Direct Mid-Turbinate Swab Sample.

FDA Status: For Use Under The Emergency Use Authorization (EUA) Only — 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 the 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.

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
Storage Room Temperature
Test Format Test Device
Test Method Lateral Flow Immunochromatographic Assay
SKU CTP60-D2-05-2
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

Additional information

Weight 15 lbs
Dimensions 24 × 19 × 10 in
Product Packaging

1 Kit (2 Tests), 4 Kits (8 Tests – Insurance Reimbursement), 30 Kits (60 Tests), 60 Kits (120 Tests), 240 Kits (480 Tests), 600 Kits (1,200 Tests), 1,920 Kit Pallet (3,840 Tests)

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