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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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50 In stock

Estimated deliver: Jan23 - Jan26

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Estimated deliver 5-7 days

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Siemens Respiratory Test Kit Clinitest® At-Home OTC COVID-19 Test 800 Tests CLIA Waived

Item Id 1211174
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
Is_Active_Vendor Y
Is_DSCSA N
Is_Discontinued N
Is_Medical_Device N
Lot_Tracking_Flag N
Number of Tests 800 Tests
On_Allocation N
Purchase Program Type Standard Purchase
Reading Type Visual Read
Sample Type Nasal Swab Sample
Specialty Immunoassay
Supplier_ID 3849247
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
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