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(Box) CorDx COVID-19 Antigen At-Home OTC, 2 Test/ Bx

SKU: BB-DX01

The CorDx COVID-19 Ag Test is a lateral flow immunoassay device intended for the qualitative detection of nucleocapsid protein antigen from the SARS-CoV-2 virus.
This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older or adult collected anterior nasal (nares) swab samples from individuals aged two years or older. This test is authorized for individuals with symptoms of COVID-19 within the first 7 days of symptom onset when tested at least twice over three days with at least 48 hours between tests, and for individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested at least three times over five days with at least 48 hours between tests.
The CorDx COVID-19 Ag Test does not differentiate between SARS-CoV and SARS-CoV-2.
Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen, which is generally detectable in anterior nasal (nares) swab specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with past medical history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Individuals who test positive with the CorDx COVID-19 Ag Test should self-isolate and seek follow-up care with their physician or healthcare provider as additional testing may be necessary.

 

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Features and benefits
  • FOR use under emergency use authorization (EUA) only.
  • FOR in vitro diagnostic use only.
  • Children of 2-13 years old should be tested by an adult.
  • Store the kit at 36~86 ?/2~30 ?. Bring the kit to room
    temperature (59~86 ?/15~30 ?) before the test.
  • Read the instructions carefully before use.

Test Kit Package Includes:

2 Test cassette, 2 Swab, 2 Tube with sample processing solution, 2 Tube holder (back of box) & User Instructions

 

  • 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; and,
  • ?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
Additional information
Weight 0.09 lbs
Dimensions 6.5 × 3 × 0.71 in
Brand

CorDx
Item

Antigen
CLIA

OTC
Registration

EUA FDA
Certifications

ISO13485
Packaging and Shipping

Packaging details:

  • Minimum order quantity: One Box
  • Packaging Details: 2 Kits/ Box, 256 Boxes/ Case
  • Weight: 0.09 lbs
  • Dimensions: 6.5'' x 3'' x 0.71''

Shipping details:

  • Shipped from US Michigan.
  • Ships Same day if ordered before 12.00 p.m EST or next Business day.
  • Return is not accepted if the case or bag is opened, or the seal is broken.
Instruction of use