Respiratory Test Kit Lucira COVID-19 and Flu Home Test 1 Test per Kit

Respiratory Test Kit Lucira COVID-19 and Flu Home Test 1 Test per Kit 
Key Features
  • SKU: PZR-0069-9701-48

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Description

  • Lucira by Pfizer COVID-19 & Flu Home Test has not been FDA cleared or approved but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA):
  • The Lucira by Pfizer COVID-19 & Flu Home Test is a single use (disposable) home test kit intended for simultaneous rapid in vitro qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B viral nucleic acid
  • This test is authorized for non-prescription home use with anterior nasal swab samples from individuals 14 years or older (self-collected) or individuals 2 years or older (collected by an adult) with signs and symptoms consistent with a respiratory tract infection, including COVID-19
  • Positive results indicate the presence of viral nucleic acid, 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 pathogens not detected by the test
  • Negative results for SARS-CoV-2 and influenza B are presumptive, meaning that they should be confirmed, if necessary for patient management, with an authorized or cleared molecular test performed in a CLIA-certified laboratory that meets requirements to perform high or moderate complexity tests
  • Negative results do not rule out SARS-CoV-2, influenza A, and/or influenza B infection and should not be used as the sole basis for treatment or other management decisions, including infection control decisions
  • This Lucira by Pfzer COVID-19 & Flu Home Test contains everything needed to perform one (1) Lucira by Pfzer COVID-19 & Flu Home Test: Instructions, 2 AA Batteries, 1 test unit, 1 sample vial, 1 sterile nasal swab and 1 disposal bag

Product Specs

Item Number 1259231
Catalog Number 0069-9701-48
UOM CS
Level 1 Family Description Lab-Waived Lab
Level 2 Category Description Lab-Respiratory Testing
Level 3 Group Description Combo Tests
Level 4 Sub-Category Description Flu-COVID Molecular Testing
Application Respiratory Test Kit
Brand Lucira
Buy American Act (BAA) Compliant No
Contents 1 Each Kit contains: (1) Test Unit, (1) Sample Vial, (1) Sterile Nasal Swab, (1) Disposable Bag, (2) AA Batteries, Instructions
Country of Origin Unknown
FSA Eligible - Buy UOM Yes
FSA Eligible - Primary UOM Yes
FSA Eligible - Sell UOM Yes
Manufacturer Pfizer (Lab)
Manufacturer # 0069-9701-48
McKesson # 1259231
Number of Tests 1 Test per Kit
Purchase Program Type Standard Purchase
Reading Type Visual Read
Sample Type Anterior Nasal Swab Sample
Specialty Molecular
Test Format Test Device Format
Test Kit Type Rapid
Test Name COVID-19 and Flu Home Test
Test Type Nucleic Acid Amplification Test (NAAT)
Time to Results 30 Minute Results
Trade Agreement Act (TAA) Compliant No
UNSPSC Code 41116144

Frequently asked questions

Does this test provide lab-quality molecular accuracy?

Yes, this kit utilizes Nucleic Acid Amplification Test (NAAT) technology, which is the same molecular method used in clinical labs, to deliver highly accurate results.

Can it detect both COVID-19 and the flu simultaneously?

Absolutely. A single nasal swab sample is used to simultaneously identify and differentiate between SARS-CoV-2 (COVID-19), influenza A, and influenza B.

How quickly will I receive my test results?

The Lucira home test is designed for speed, providing clear, visual results in approximately 30 minutes.

Is this test suitable for children to use?

The test is authorized for:

  • Self-testing for individuals 14 years or older.
  • Assisted testing for individuals 2 years or older, when performed by an adult.
Is everything I need included in the package?

Yes, this is a complete, all-in-one kit. It includes:

  • 1 Test Unit
  • 1 Sample Vial
  • 1 Sterile Nasal Swab
  • 1 Disposable Bag
  • 2 AA Batteries (required for the unit)
  • Step-by-step instructions
Can I use my FSA funds for this purchase?

Yes, the Lucira by Pfizer COVID-19 & Flu Home Test is FSA eligible, making it a convenient healthcare expense.

Does it require a prescription to purchase?

No, this product is authorized for non-prescription use, allowing you to keep it on hand for when symptoms arise.

How do I perform the nasal swab for this test?

The test uses an anterior nasal swab, which is designed for easy, comfortable self-collection. Please follow the detailed instructions provided in the kit to ensure the sample is collected correctly.

What should I do if I get a negative result?

A negative result is considered presumptive. If you continue to have symptoms or if it is clinically necessary for your medical management, you should confirm the result via a CLIA-certified laboratory.

Is this test authorized for emergency use?

Yes, this kit is authorized for emergency use by the FDA under an Emergency Use Authorization (EUA).