-
,for, Item ID-
- #1242186
- Providers like you icon 23
- Pfizer (Lab) #00069970131
Respiratory Test Kit Lucira™ COVID-19 / Flu A + B 1 Test per Kit
TEST KIT, LUCIRA COVID/FLU MOLECULAR DISP SNGL USE (1TEST)
Features
- 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
- More …
Product Details Email
Product Specifications
McKesson # | 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 |
NDC Number | 00069970131 |
Number of Tests | 1 Test per Kit |
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 |
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 |
UNSPSC Code | 41116144 |
Features
- 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 maintenance, and no extensive training needed for your staff
- For Use under Emergency Use Authorization (EUA) only
- For in vitro Diagnostic Use
- Rx Only
More Information
Professionals Also Viewed
![](https://imgcdn.mckesson.com/CumulusWeb/Images/Item_Detail/951316_ppkgleft.jpg)
-
,for, Item ID-
- #951316
- Providers like you icon 5,001
- McKesson Brand #5003
- A rapid test for the qualitative detection of Strep A antigen in throa …
- CLIA waived and easy to use
- Contents: 25 Dipsticks (in sealed pouches), Disposable extraction test …
![](https://imgcdn.mckesson.com/CumulusWeb/Images/Item_Detail/1076728_ppkgleft.jpg)
-
,for, Item ID-
- #1076728
- Providers like you icon 4,436
- McKesson Brand #181-36025
- Rapid qualitative test that detects Influenza type A and type B antige …
- Color-coded control swab packaging for easy positive/negative identifi …
- Results in under 15 minutes
![](https://imgcdn.mckesson.com/CumulusWeb/Images/Item_Detail/951312_ppkgleft.jpg)
-
,for, Item ID-
- #951312
- Providers like you icon 4,278
- McKesson Brand #4999
- A rapid test for the qualitative detection of Strep A antigen in throa …
- CLIA waived and easy to use
- Contents: 50 Dipsticks (2 vials of 25), Disposable extraction test tub …
![](https://imgcdn.mckesson.com/CumulusWeb/Images/Item_Detail/1127458_ppkgleft.jpg)
-
,for, Item ID-
- #1127458
- Providers like you icon 431
- McKesson Brand #181-34125
- A rapid test for the qualitative detection of Strep A antigen in throa …
- Easy-to-use flip step eliminates need for pipetting
- Fast, accurate detection of Group A Strep with walk-away convenience