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,for, Item ID-
- #1166253
- Providers like you icon 891
- Quidel #20374
Respiratory Test Kit Sofia® SARS Antigen FIA 25 Tests CLIA Waived
TEST KIT, SOFIA 2 SARS ANTIGENFIA (25TESTS/KT 12KT/CS)
Features
- Sofia® SARS Antigen FIA test is only for use under the Food and Drug Administration’s Emergency Use Authorization: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
- Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate, high or waived complexity tests
- Product ships with minimum 60 days dating
- More …
Product Details Email
Product Specifications
McKesson # | 1166253 |
---|---|
Manufacturer # | 20374 |
Brand | Sofia® |
Manufacturer | Quidel |
Country of Origin | United States |
Application | Respiratory Test Kit |
CLIA Classified | CLIA Waived |
Contents 1 | (25) Individually Packaged Test Cassettes, (25) Reagent Tubes, (25) Ampoules of Reagent Solution, (25) Sterile Nasal Swabs, (25) X 120 µL Fixed Volume Pipettes, Positive Control Swab, Negative Control Swab, Package Insert, Quick Reference Instructions, QC Card |
For Use With | For use with Sofia / Sofia 2 Instrument |
Is_ECAT | N |
Is_GSA | Y |
Is_VA | N |
Number of Tests | 25 Tests |
Product Dating | McKesson Acceptable Dating: we will ship >= 60 days |
Purchase Program Type | Standard Purchase |
Reading Type | Machine Read |
Sample Type | Nasal Swab / Nasopharyngeal Swab Sample |
Specialty | Immunoassay |
Technology | Immunofluorescent Sandwich Assay |
Test Format | Cassette Format |
Test Kit Type | Rapid |
Test Name | SARS Antigen FIA |
Test Type | Fluorescence Immunoassay (FIA) |
Time to Results | 15 Minute Results |
UNSPSC Code | 41116205 |
Features
- Sofia® SARS Antigen FIA test is only for use under the Food and Drug Administration’s Emergency Use Authorization: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
- Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate, high or waived complexity tests
- Product ships with minimum 60 days dating
- This 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
- The SARS Antigen FIA does not differentiate between SARS-CoV and SARS-CoV-2
- 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; the agent detected may not be the definite cause of disease
- Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities
- Negative results do not rule out COVID-19 and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions
- Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19
- Rapid results in 15 minutes to support efficient dispositioning of patients
- Objective, accurate results without cross-reactivity to seasonal coronaviruses
- The Sofia SARS Antigen FIA is a lateral flow immunofluorescent sandwich assay that is used with the Sofia and Sofia 2 instrument
- Seamless test workflow follows a similar format to CLIA-waived Sofia and Sofia 2 assays
- Dual work modes adjust to volume fluctuations and allows for significant throughput and batching of samples in READ NOW Mode
- Fluorescent technology with automated read eliminates the subjectivity of a visual result
- Virena provides automated tracking, data capture, government reporting, and exclusive disease mapping
- All necessary components included in kit, ready for use for nasal swab procedure
- Self-contained Test Cassette that is clean, easy to use and dispose of
- For in vitro diagnostic use; RX only
More Information
- Sofia SARS 2 Antigen FIA FDA EUA Letter
- Sofia SARS Antigen FIA IFU
- Sofia SARS Antigen FDA EUA June 9 Addendum
- Sofia SARS Antigen FIA Health Care Provider Fact Sheet
- Sofia SARS Antigen FIA Patient Fact Sheet
- Quidel 12.28.21 Omicron Variant Letter
- Sofia SARS Antigen FAQs
- Sofia SARS Antigen Firmware Notification Letter
- SDS
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