Description
- The LUCIRA by Pfizer COVID-19 & Flu Test has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories: https://www.fda.gov/medical-devices/covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-molecular-diagnostic-tests-sars-cov-2
- The Lucira by Pfizer COVID-19 & Flu Test is a rapid, instrument-free, single-use molecular diagnostic test for the qualitative detection of SARS-CoV-2, Influenza A, and Influenza B RNA from anterior nasal swab samples in individuals with known or suspected COVID-19 or flu
- Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high, moderate or waived complexity tests
- The Lucira by Pfizer COVID-19 & Flu Test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation
- Results are for the simultaneous detection and differentiation of SARS-CoV-2, Influenza A, and Influenza B viral RNA in clinical specimens and is not intended to detect Influenza C virus
- Positive results are indicative of the presence of SARS-CoV-2, Influenza A, and/or Influenza B RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient 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 and should be confirmed with an alternative molecular FDA-cleared or authorized assay
- Laboratories within the United States and its territories are required to report all SARS-CoV-2 results to the appropriate public health authorities
- As a single-use test, LUCIRA® by Pfizer makes it easy to onboard molecular testing technology: no calibration, no on-going maintece, and no extensive training needed for your staff
- For Use under Emergency Use Authorization (EUA) only
- For in vitro Diagnostic Use
- Rx Only
| SKU # | 1242186 |
| Manufacturer # | 00069970131 |
| Brand | Lucira™ |
| Manufacturer | Pfizer (Lab) |
| Country of Origin | Unknown |
| Application | Respiratory Test Kit |
| Contents 1 | (1) Test Unit with Lyophilized Reagents and Electronic Readout, (1) Nasal Swab (Sterile Flocked Swab in Peel-Pouch), (1) Single Use Sample Vial, (2) AA Batteries for Test Unit, (1) Plastic Disposable Bag, Package Insert |
| Is_Active_Vendor | Y |
| Is_DSCSA | N |
| Is_Discontinued | N |
| Is_Medical_Device | N |
| Lot_Tracking_Flag | N |
| NDC Number | 00069970131 |
| Number of Tests | 1 Test per Kit |
| On_Allocation | N |
| Product Dating | McKesson Acceptable Dating: we will ship >= 60 days |
| Purchase Program Type | Standard Purchase |
| Reading Type | Visual Read |
| Sample Type | Anterior Nasal Swab Sample |
| Specialty | Molecular |
| Supplier_ID | 3883899 |
| Technology | RT-LAMP Amplification Technology |
| Test Format | Test Device Format |
| Test Kit Type | Rapid |
| Test Method | Nucleic Acid Amplification Test (NAAT) |
| Test Name | COVID-19 / Flu A + B |
| Test Type | Molecular Diagnostic |
| Time to Results | 30 Minute Results |
