Celltrion DiaTrust™ COVID-19 Ag Home Test

In stock

Celltrion DiaTrust™ COVID-19 Ag Home Test 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. Due to FDA guidelines and supply chain demands all orders for this product are non-cancellable and non-returnable. This Item is not for resale.

SKU CLT76323P

Description
Additional information

Features

Test for both symptomatic and asymptomatic COVID-19
Detects all known COVID-19 Variants
QR code for result tracking on packaging
Two Tests included for staggered testing over a 36 hour period
Visual results available in 15 minutes

Celltrion DiaTrust™ COVID‐19 Ag Home Test Video (CLICK HERE)

Kit Contents

Two (2) test devices
Two (2) shallow nasal swabs
Two (2) buffer solutions vials with caps
Instructions for use

Performance Measures

86.7% Sensitivity
99.8% Specificity

Additional Information

Disclaimer

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 sooner.

Weight	N/A
UOM	Kit/1 – 2 tests, Master case – 120 tests