Quidel QuickVue At-Home OTC COVID-19, Includes 2 Tests

Quidel QuickVue At-Home OTC COVID-19, Includes 2 Tests - American Hospital Supply
Quidel QuickVue At-Home OTC COVID-19, Includes 2 Tests - American Hospital Supply

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Quidel QuickVue At-Home OTC COVID-19, Includes 2 Tests


Vendor
Quidel
SKU:
5520402_BX
$28.90

 

Description

The QuickVue At-Home OTC COVID-19 Test is intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in individuals with or without symptoms, or other epidemiological reasons to suspect COVID-19. The test should be administered twice over two or three days, with at least 24 hours and no more than 36 hours between tests. It is authorized for nonprescription home use with self-collected (unobserved) direct anterior nasal (NS) swab specimens from individuals aged 14 years and older, or with adult-collected anterior NS samples from individuals aged 2 years or older.

Features 

  • Reliable COVID at home test with results in 10 minutes from swabbing
  • Includes two test to test over time or for multiple family members
  • EUA approved for self-collection for individuals aged 14 or older

Specifications

Manufacturer Quidel
Part # 5520402
Test type Lateral flow immunoassay
Specimen type Nasal (NS) swab specimen
Result Times Intended to be read at 10 minutes.  If the test is read before this or is read more than 5 minutes after the indicated read time, results may be inaccurate (false negative, false positive, or invalid) and the test should be repeated.
CLIA Status authorized for nonprescription home use with self-collected (unobserved) direct anterior nasal (NS) swab specimens from individuals aged 14 years and older or with adult-collected anterior NS samples from individuals aged 2 years or older. FDA status: EUA granted
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 SARSCoV-2, not for any other viruses or pathogens; and,
  • 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.



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