Clinitest - Rapid Test Kit Antigen Detection At-Home OTC COVID-19 Test Anterior Nasal Swab Sample 5 Tests per Kit - 11556711

by Siemens
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$46.99
SKU 11556711
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  • The CLINITEST At-Home OTC COVID-19 Test is only for use under an FDA EUA: 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
  • Ships with minimum 30 Days Dating
  • The CLINITEST At-Home OTC COVID-19 Test is a lateral flow chromatographic immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2
  • This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older with symptoms of COVID-19 within the first 7 days of symptom onset
  • This test is also authorized for non-prescription home use with adult-collected anterior nasal (nares) swab samples from individuals aged 2 years or older with symptoms of COVID-19 within the first 7 days of symptom onset
  • This test is also 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 2 years or older, with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests
  • Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen; antigen is generally detectable in anterior nasal (nares) swabs 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
  • Individuals who test positive with CLINITEST Rapid COVID-19 Antigen Self-Test should self-isolate and seek follow-up care with their physician or healthcare provider as additional testing may be necessary
  • Negative results should be treated as presumptive and confirmation with a molecular assay, if necessary, for patient management, may be performed
  • Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions
  • Individuals should provide all results obtained with this product to their healthcare provider for public health reporting
  • 86.5% Sensitivity; 99.3% Specificity
  • Qualitative; visually interpreted, no instrument required

Stock Number : 1203770

Manufacturer # : 11556711

Brand : Clinitest

Manufacturer : Siemens

Country of Origin : China

Application : Rapid Test Kit

Contents 1 : (5) Test Devices, (5) Sterile Swabs, (5) Extraction Tubes with Buffer and Tips, Instructions for Use

HCPCS : U0002

Number of Tests : 5 Tests per Kit

Product Dating : McKesson Acceptable Dating: we will ship >= 30 days

Reading Type : Visual Read

Sample Type : Anterior Nasal Swab Sample

Test Format : Cassette Format

Test Method : Lateral Flow Chromatographic Immunoassay

Test Name : At-Home OTC COVID-19 Test

Test Type : Antigen Detection

Time to Results : 15 Minute Results

UNSPSC Code : 41116205

CLINITEST COVID-19 RAPID ANTI GEN OTC (5/KT 170KT/CS)

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