秒速飞艇开奖直播

  • Results in 15 minutes
  • Detects the nucleocapsid protein antigen from SARS-CoV-2
  • Nasal Specimen sample
  • FDA Emergency Use Authorization (EUA)
  • Positive Percent Agreement (PPA): 93% (95% Cl: 81%-99%)
  • Negative Percent Agreement (NPA): 100% (95% Cl: 97%-100%)

$10.00

秒速飞艇开奖直播

SKU NBGS-FF-OTC Category

秒速飞艇全天开奖

Flowflex COVID-19 Antigen Home Test is a rapid test for the detection of SARS-CoV-2 antigens in anterior nasal specimens directly from individuals within 7 days of symptom onset or without symptoms or other epidemiological reasons to suspect COVID-19 infection. For self-testing use. For use under an Emergency Use Authorization (EUA) only.

秒速飞艇7码计划

This test has not been FDA cleared or approved; the test has been authorized by FDA under an Emergency Use Authorization (EUA) for use by laboratories certified under the CLIA that meet the requirements to perform moderate, high or waived complexity tests. This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

Product Insert Information |FDA Emergency Use Authorization Letter

秒速飞艇网站注册

Positive Percent Agreement: 93.0%

Negative Percent Agreement: 100%

秒速飞艇下载

This COVID-19 rapid antigen nasal test kit is sold in a single box and includes the following:

  • (1) Rapid Testing Cassettes
    • Foil pouched test device containing one test strip which
      is encased in plastic device cassette.
  • (1) Extraction Vials/Caps
    • The extraction vial contains 400 μl extraction buffer
      solution.
  • (1) Disposable Nasal Swab
    • Swabs for shallow nasal specimen collection
  • (1) Instruction For Use Insert

秒速飞艇龙虎走势图

  • This COVID-19 Antigen test is a lateral flow immunochromatographic assay
    intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in
    nasopharyngeal swab specimens directly collected, or collected in BD universal transport media,
    from individuals suspected of COVID-19 by their healthcare provider within five days of symptom
    onset.
  • This test is authorized for Over The Counter Use (OTC)
  • Results are for the identification of the SARS-CoV-2 nucleocapsid protein antigen. The antigen
    is generally detectable in anterior nasal swab specimens during the acute phase of infection.
  • Positive results indicate the presence of viral antigens, but the clinical correlation with patient
    history and other diagnostic information is necessary to determine infection status. Positive
    results do not rule out a bacterial infection or co-infection with other viruses. The agent detected
    may not be the definite cause of disease. Laboratories within the United States and its territories
    are required to report all results to the appropriate public health authorities.
  • Negative results are 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. Negative results should be considered in the context of a
    patient’s recent exposures, history and the presence of clinical signs and symptoms consistent
    with COVID-19.

秒速飞艇预测软件下载

Type Of Test

Rapid Antigen Nasal Test

Designation

OTC

秒速飞艇走势图开奖号码

There are no reviews yet.

Be the first to review “FlowFlex Rapid Antigen Test”

Your email address will not be published.