Respiratory Test Kit Genabio COVID-19 Rapid Self-Test 2 Tests per Kit

Respiratory Test Kit Genabio COVID-19 Rapid Self-Test 2 Tests per Kit 
Key Features
  • SKU: GEO-RA9-E00302

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Description

  • Genabio COVID-19 Rapid Self Test is for use under an FDA Emergency Use Authorization only:
  • The Genabio COVID-19 Rapid Self-Test Kit 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 2 years or older
  • This test is authorized for individuals with symptoms of COVID-19 within the first 7 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
  • Positive results indicate the presence of viral antigens, but clinical correlation with patient 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 and the agent detected may not be the definitive cause of disease
  • Individuals who test positive with the Genabio COVID-19 Rapid Self-Test Kit should self-isolate and seek follow-up care with their physician or healthcare provider as additional testing may be necessary
  • 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 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

Product Specs

Item Number 1271385
Catalog Number RA9-E00302
UOM CS
Level 1 Family Description Lab-Waived Lab
Level 2 Category Description Lab-Respiratory Testing
Level 3 Group Description COVID Testing
Level 4 Sub-Category Description COVID - Rapids
Application Respiratory Test Kit
Brand Genabio
Buy American Act (BAA) Compliant No
Contents 1 Each Kit Contains: (2) Covid-19 Test Cards, (2) Nasal Swabs, (2) Tubes, Quick Guide Instruction
Country of Origin China
FSA Eligible - Buy UOM Yes
FSA Eligible - Primary UOM Yes
FSA Eligible - Sell UOM Yes
Manufacturer Genabio Diagnostics Inc
Manufacturer # RA9-E00302
McKesson # 1271385
Number of Tests 2 Tests per Kit
Purchase Program Type Standard Purchase
Reading Type Visual Read
Sample Type Anterior Nasal Swab Sample
Specialty Immunoassay
Test Format Cassette Format
Test Kit Type Rapid
Test Method Lateral Flow
Test Name COVID-19 Rapid Self-Test
Time to Results 15 Minute Results
Trade Agreement Act (TAA) Compliant No
UNSPSC Code 41116205

Frequently asked questions

How quickly will I get my test results?

This rapid test provides clear, diagnostic results in just 15 minutes, allowing you to make quick decisions regarding your health.

Is this kit suitable for children?

The test is intended for self-collection by individuals aged 14 and older. For children aged 2 or older, an adult can collect the nasal swab sample for them.

Can I use this without a prescription?

Yes, this is an FDA-authorized diagnostic tool intended for non-prescription home use, making it accessible whenever you need it.

Does this test detect other respiratory illnesses?

No, this test is specifically for the qualitative detection of the SARS-CoV-2 nucleocapsid protein antigen. A positive result indicates the presence of COVID-19 antigens but does not rule out co-infection with other pathogens.

Can I use this with my FSA account?

Yes, this product is FSA eligible, allowing you to use your flexible spending account for the purchase.

What does a negative test result mean?

A negative result is presumptive. It does not definitively rule out a SARS-CoV-2 infection and should be considered alongside your medical history, symptoms, and any recent potential exposures.

Why does the kit include two tests?

Having two tests in one kit is ideal for serial testing protocols, which are frequently recommended by health guidelines to improve the accuracy of at-home screening over time.

What is included in the test kit?

Each kit contains everything you need for two complete tests:

  • 2 Test Cards
  • 2 Nasal Swabs
  • 2 Extraction Tubes
  • 1 Quick Guide Instruction
Is this test easy to read?

Yes, it features a simple visual read format. The test cassette includes a window labeled with C (Control) and T (Test) indicators for clear and straightforward results.

Is this test suitable if I have no symptoms?

Yes, this test is intended for individuals experiencing symptoms as well as those without symptoms who have epidemiological reasons to suspect an infection, such as recent exposure.