- #1209323
- Intrivo Diagnostics #RCPM-00279-B
Respiratory Test Kit On/Go™ Antigen Detection COVID-19 At-Home Rapid Antigen Test Nasal Swab Sample 232 Boxes per Case / 2 Tests per Box
TEST KIT, COVID-19 ON/GO RAPIDANTIGEN OTC (2/BX 232BX/CS)
Features
- The on/go™ COVID-19 Antigen Self-Test has not been FDA cleared or approved but has been authorized by FDA under an Emergency Use Authorization (EUA): https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2
- Ships with minimum 30 Days Dating
- The on/go™ COVID-19 Antigen Self-Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigens from SARS-CoV-2
- More …
Product Details Email
Product Specifications
McKesson # | 1209323 |
Manufacturer # | RCPM-00279-B |
Brand | On/Go™ |
Manufacturer | Intrivo Diagnostics |
Country of Origin | United States |
Application | Respiratory Test Kit |
CLIA Classified | CLIA Waived |
Contents 1 | Each Box contains (2) Test Cassettes, (2) Nasal Swabs, (2) Reagent Vials and (2) Vial Caps |
For Use With | For use with iOS / Android Mobile Devices and the On/Go App |
HCPCS | U0002 |
Number of Tests | 232 Boxes per Case / 2 Tests per Box |
Purchase Program Type | Standard Purchase |
Reading Type | Visual Read |
Sample Type | Nasal Swab Sample |
Specialty | Immunoassay |
Test Format | Cassette Format |
Test Method | Lateral Flow Chromatographic Immunoassay |
Test Name | COVID-19 At-Home Rapid Antigen Test |
Test Type | Antigen Detection |
Time to Results | 10 Minute Results |
UNSPSC Code | 41116144 |
Features
- The on/go™ COVID-19 Antigen Self-Test has not been FDA cleared or approved but has been authorized by FDA under an Emergency Use Authorization (EUA): https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2
- Ships with minimum 30 Days Dating
- The on/go™ COVID-19 Antigen Self-Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigens from SARS-CoV-2
- This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older with symptoms of COVID-19 within the first 7 days of symptom onset
- This test is also authorized for non-prescription home use with adult-collected nasal (nares) swab samples from individuals aged 2 years or older with symptoms of COVID-19 within the first 7 days of symptom onset
- Positive results indicate the presence of viral antigens, but clinical correlation with past medical 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 and the agent detected may not be the definite cause of disease
- Negative results should be treated as presumptive and confirmation with a molecular assay for patient management, may be performed if necessary; negative results do not rule out SARS-CoV-2 infection, and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions
- Detects the antigen protein of all known major COVID-19 variants of concern (including Delta and Omicron)
- Material required but not provided: Smartphone: iOS13 or newer / Android 10 or newer, Mobile App (Prior to testing, the user should download the free mobile application, on/go™ App, for iOS or Android smartphones)
More Information
- CareStart COVID-19 Antigen Home Test FDA EUA
- On/Go COVID-19 Antigen Self Test IFU
- On/Go COVID-19 Antigen Self-Test Individuals Fact Sheet
- On/Go COVID-19 Antigen Self-Test Healthcare Provider Fact Sheet
- COVID-19 Dec 2021 Variant Brief
- COVID-19 Antigen Self-Test Extension Confirmation Jan 20 2022
- On/Go COVID-19 Ag Self-Test Exp Date Extension Notification May 2022
- On/Go COVID-19 Ag Self-Test Exp Date Extension Notification August 2022
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