Respiratory Test Kit SpeedySwab COVID-19 / Flu A+B Antigen Self-Test 2 Tests per Kit

Key Features

SKU: 2SA-CVF002US-2
Condition: Factory New
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MFR: 2San LLC Ships from MFI Medical
MPN: CVF002US-2

$4,988.78

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Description

The Speedy Swab Rapid COVID-19 + Flu A&B Antigen Self-Test is only for use under the Food and Drug Administration’s Emergency Use Authorization:
The Speedy Swab Rapid COVID-19 + FLU A&B Antigen Self-Test is a rapid, qualitative lateral flow immunoassay for the determination of the presence of SARS-CoV-2 and influenza A&B antigens in anterior nasal swab specimens
The test strip in each device contains mouse monoclonal capture antibodies to the nucleocapsid protein (NP) of SARS-CoV-2, Influenza A and Influenza B and goat anti-Mouse IgG control antibody immobilized in the test and control regions on the nitrocellulose membrane, respectively
This test is authorized for non-prescription home use with self-collected anterior nasal swab specimens from individuals aged 14 years or older, or with adult-collected anterior nasal swab specimens from individuals two (2) years or older
This test is only authorized for individuals with signs and symptoms of respiratory infection consistent with COVID-19 within the first five (5) days of symptom onset when tested at least twice over three days with at least 48 hours between tests
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
Individuals who test positive with the Speedy Swab Rapid COVID-19 + Flu A&B Antigen Self-Test should self-isolate and seek follow-up care with their physician or healthcare provider as additional testing may be necessary All negative results are pres
All negative results are presumptive and confirmation with a molecular assay, if necessary for patient management, may be performed
Negative results do not rule out SARS-CoV-2, influenza A, and influenza B infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions such as isolating from others and wearing masks
Negative results should be considered in the context of an individual’s recent exposures, history, and the presence of clinical signs and symptoms consistent with SARS-CoV-2, influenza A, and influenza B infection

Product Specs

Item Number	1265221
Catalog Number	CVF002US-2
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 Reader Testing
Application	Respiratory Test Kit
Brand	SpeedySwab
Buy American Act (BAA) Compliant	No
Contents 1	Each Kit has: (2) Test Devices, (2) Sterile Nasal Swabs, (2) Test Tubes with Buffer Solution, Tube Holder in Box Top, Quick Ref Instructions
Country of Origin	Unknown
Manufacturer	2San LLC
Manufacturer #	CVF002US-2
McKesson #	1265221
Number of Tests	2 Tests per Kit
Purchase Program Type	Standard Purchase
Reading Type	Visual Read
Sample Type	Anterior Nasal Swab Sample
Specialty	Immunoassay
Test Kit Type	Rapid
Test Method	Lateral Flow Immunoassay
Test Name	COVID-19 / Flu A+B Antigen Self-Test
Time to Results	15 Minute Results
Trade Agreement Act (TAA) Compliant	No
UNSPSC Code	41116144