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LifeSign Status EUA Authorized COVID-19/Flu A&B Test Kit, 25 tests/bx (25 Tests) (Item is Non-Returnable)
Respiratory Test Kit Status COVID-19 / Flu A and B 25 Tests CLIA Waived
TEST KIT, RAPID SARS COV-2/FLUA&B ANTIGEN (25TESTS/KT)
A Rapid Immunoassay for the Simultaneous Direct Detection and Differential Diagnosis of SARS-CoV-2, Influenza Type A and Type B Antigen from anterior nasal and nasopharyngeal swab specimens
1 test + 1 specimen = 3 Results
COVID-19
- Anterior nasal swab specimen Sensitivity 93.8 %, Specificity 100%
- Nasopharyngeal Sensitivity 93.1 %, Specificity 100%
Flu A - Sensitivity 91.4%, Specificity 95.7%
Flu B - Sensitivity 87.6%, Specificity 95.9%
FDA Emergency Use Authorization (EUA)
Visually read in 15 minutes
Flocked nasopharyngeal swab for superior specimen collection and patient comfort
Status COVID-19/Flu A&B:
Specifications:
CPT Code Information:
Contents:
FAQ:
Is this an antigen or antibody test?
The Status COVID-19/Flu A&B test is an antigen test, using the preferred nasopharyngeal specimen collection.
What is the item number and contents?
Item number 33225; 25 test cassettes, 25 specimen collection swabs, 25 reagent capsules, 1 pos/1neg control swabs.
What is the expiration dating?
Currently six months from date of manufacturing.
What CPT code should be used?
There are CPT codes assigned for both COVID-19 and Flu A&B. COVID-19: 87811QW, Flu A: 87804QW, Flu B: 87804QW-59. As the manufacturer, we cannot guarantee reimbursement values or standard billing procedures.
Is the Status COVID-19/Flu A&B test CLIA Waived?
Through the EUA approval process the FDA authorizes tests for use at the point of care (including COVID-19) under an EUA, such tests are deemed to be CLIA waived tests. Accordingly, for the duration of the emergency declaration, such tests can be performed in a patient care setting that is qualified to have the test performed there as a result of operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
SKU: 33225
Origin of Manufacture: USA
This product has the following special restrictions:
- Requires CLIA Certification
- Product is not returnable
- Product is not cancellable
$9.95 Flat Rate GND (1-5 BUS DAYS), in continental USA. Free shipping on $2500 and above. Exclusions may apply.
No Cancellations; No Returns; All Sales Final. Exclusions may apply. All returns must be approved by our Returns Department. An e-mail notification will be issued regarding your return status and return instructions, should this apply. Any product returned for credit without an authorized RMA number clearly printed on the outside package or shipping label will be refused. Unauthorized returns will not be honored or accepted for credit.
*This item may only ship to a Medical Facility*
*This item is not intended for consumer use*
SLI Medical:
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