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Siemens Respiratory Test Kit Clinitest® At-Home OTC COVID-19 Test 800 Tests CLIA Waived - Case of 200 - 11561909-CS

Siemens Respiratory Test Kit Clinitest® At-Home OTC COVID-19 Test 800 Tests CLIA Waived - Case of 200 - 11561909-CS

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11561909-CS
Regular price $7,167.99
Sale price $7,167.99 Regular price
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Siemens Respiratory Test Kit Clinitest® At-Home OTC COVID-19 Test 800 Tests CLIA Waived

This Respiratory Test Kit from Clinitest® is ideal for clinics, laboratories and point-of-care testing. Sold by the case of 200.

MF Id# 11561909
Brand Clinitest®
Manufacturer Siemens
Country of Origin China
Application Respiratory Test Kit
CLIA Classified CLIA Waived
Contents 1 Each Kit has: (4) Test Devices, (4) Sterile Swabs, (4) Extraction Tubes with Buffers and Tips, Instructions for Use
Number of Tests 800 Tests
Purchase Program Type Standard Purchase
Reading Type Visual Read
Sample Type Nasal Swab Sample
Specialty Immunoassay
Test Format Cassette Format
Test Kit Type Rapid
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 41116144

Features

  • The CLINITEST® Rapid COVID-19 Antigen Self-Test is only for use under the Food and Drug Administration’s Emergency Use Authorization: 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
  • 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
  • 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
  • With the CLINITEST® Rapid COVID-19 Antigen Self-Test, you can expect accurate and reliable results in just 15 minutes
  • 200 4pk kits in a case or 800 total tests