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#1001211174 | Mfg #11561909 | Clinical Laboratory

Rapid Test Kit Clinitest® Antigen Detection At-Home OTC COVID-19 Test Nasal Swab Sample 800 Tests

CLINITEST, COV19 AG HOME US ALBERTSON (4/KT 200KT/CS)
Rapid Test Kit Clinitest® Antigen Detection At-Home OTC COVID-19 Test Nasal Swab Sample 800 Tests

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

Product Specifications

MSFH #
1001211174, 11561909
Manufacturer #
Clinitest®, Siemens
Brand
China
Manufacturer
Rapid Test Kit
Country of Origin
Each Kit has: (4) Test Devices
Application
(4) Sterile Swabs, (4) Extraction Tubes with Buffers and Tips
Contents 1
Instructions for Use
Number of Tests
800 Tests
Reading Type
Visual Read
Sample Type
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
41116144

Description

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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