Respiratory Test Kit BinaxNOW™ COVID-19 Antigen Self Test 2 Tests

Product Information

Specifications for Respiratory Test Kit BinaxNOW™ COVID-19 Antigen Self Test 2 Tests

Manufacturer	Abbott Rapid Dx North America LLC
Part Number	195160K
Application	Respiratory Test Kit
Brand	BinaxNOW™
Contents 1	Each Kit: (2) Test Cards, (2) Bottles of < 1 mL Extraction Reagent, (2) Sterile Nasal Swabs, Patient Instructions for Use and Individual Fact Sheet
Contract Type	Local
Number of Tests	2 Tests
Purchase Program Type	Standard Purchase
Reading Type	Visual Read
Sample Type	Anterior Nasal Swab Sample
Specialty	Immunoassay
Test Format	Test Card Format
Test Kit Type	Rapid
Test Method	Lateral Flow Immunoassay
Test Name	COVID-19 Antigen Self Test
Test Type	Antigen Detection
Time to Results	15 Minute Results
UNSPSC Code	41116010

Product Properties:

Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status
BinaxNow™ COVID-19 Antigen Self Test is for use with an FDA Emergency Use Authorization only: https://www.fda.gov/medical-devices/covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2
This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 15 years or older or adult collected anterior nasal (nares) swab samples from individuals 2 years or older
The BinaxNOW COVID-19 Antigen Self Test is intended for non-prescription self-use and/or, as applicable for an adult lay user testing another person aged 2 years or older in a non-laboratory setting
All negative results should be treated as presumptive and confirmation with a molecular assay, if necessary for patient management, may be performed
Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease
This test is authorized for individuals with symptoms of COVID-19 within the first seven 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 reasons to suspect COVID-19, when tested at least three times over five days with at least 48 hours between tests
Negative results should be considered in the context of an individual’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19
The BinaxNOW COVID-19 Antigen Self Test does not differentiate between SARS-CoV and SARS-CoV-2
Individuals who test positive with the BinaxNOW 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
The BinaxNOW COVID-19 Antigen Self Test is only for use under the Food and Drug Administration’s Emergency Use Authorization; this product has not been FDA cleared or approved
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
The BinaxNOW™ COVID-19 Antigen Self Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2.

Respiratory Test Kit BinaxNOW™ COVID-19 Antigen Self Test 2 Tests

Respiratory Test Kit BinaxNOW™ COVID-19 Antigen Self Test 2 Tests

Application

Brand

Contents 1

Contract Type

Country of Origin

Number of Tests

Product Dating

Purchase Program Type

Reading Type

Sample Type

Specialty

Test Format

Test Kit Type

Test Method

Test Name

Test Type

Time to Results

UNSPSC Code

Specifications for Respiratory Test Kit BinaxNOW™ COVID-19 Antigen Self Test 2 Tests

Newsletter Signup: