Respiratory Test Kit FaStep® COVID-19 Antigen Pen Test 1 Test per Kit (144 Kits per Case)
About this item
- The Fastep COVID-19 Antigen Pen Home Test is for FDA Emergency Use Authorization (EUA) only: https://www.fda.gov/medical-devices/covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2
- Fastep COVID-19 Antigen Pen Home Test is a lateral flow immunoassay device intended for the qualitative detection of nucleocapsid protein antigen from the SARS-CoV-2 virus
- This test is 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 two (2) years or older
- This test is authorized for individuals with symptoms of COVID-19 within the first 6 days of symptom onset when tested at least twice over three days with at least 48 hours between tests, and for individuals without symptoms or other epidemiological
- 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-infec
- All 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 measures such as isolating from others and wearing masks; negative results shoul
- All healthcare providers will report all test results they receive from individuals who use the authorized product to relevant public health authorities in accordance with local, state, and federal requirements using appropriate LOINC and SNOMED code
- The Fastep® COVID-19 Antigen Pen Home Test is a single test comprised of a base and a test pen with an integrated sample swab and test strip
- Each Fastep® COVID-19 Antigen Pen Home Test has a built-in internal procedural control
Price: Available Upon Quote
50+ In Stock.
TEST KIT, COVID-19 FASTEP PEN 1-PACK (144KT/CS)
Product Specifications:
Manufacturer #: | USCO5FS-1 |
---|---|
Brand: | FaStep® |
Manufacturer: | 2San LLC |
Country of Origin: | Unknown |
Application: | Respiratory Test Kit |
Contents 1: | Each Kit contains (1) Foil Package with Base and Test Pen, (1) Package Insert |
Number of Tests: | 1 Test per Kit (144 Kits per Case) |
Product Dating: | McKesson Acceptable Dating: we will ship >= 90 days |
Purchase Program Type: | Standard Purchase |
Reading Type: | Visual Read |
Sample Type: | Anterior Nasal (Nares) Swab Sample |
Specialty: | Immunoassay |
Test Format: | Test Device Format |
Test Kit Type: | Rapid |
Test Method: | Lateral Flow |
Test Name: | COVID-19 Antigen Pen Test |
Test Type: | Home Test Device |