Product Overview
Manufacturer
- ACON LABORATORIE
Features
- Flowflex Covid-19 Antigen Home test is for use under an FDA 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
- Product ships with minimum 30 days dating
- Qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in anterior nasal swab specimens directly from individuals within 7 days of symptom onset or without symptoms or other epidemiological reasons to suspect COVID-19 infection
- This test is authorized for non-prescription home use with self-collected anterior nasal swab specimens directly from individuals aged 14 years and older or with adult-collected anterior nasal samples directly from individuals aged 2 years or older
- 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 should self-isolate and consult their healthcare provider as additional testing may be necessary and for public health reporting
- Negative results are presumptive, and confirmation with a molecular assay, if necessary for patient management, may be performed
- 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 COVID-19
- Clinical performance showed 93% sensitivity and 100% specificity
Attributes
- Application: Respiratory Test Kit
- Contents 1: Case of 300 Boxes, each Box containing: Test Cassette, Disposable Nasal Swab, Extraction Buffer Tube and Package Insert
- HCPCS: U0002
- Is_Active_Vendor: Y
- Is_DSCSA: N
- Is_Discontinued: N
- Is_Medical_Device: N
- Lot_Tracking_Flag: Y
- Number of Tests: 300 Tests per Case / 1 Test per Box
- On_Allocation: N
- Product Dating: McKesson Acceptable Dating: we will ship >= 30 days
- Purchase Program Type: Standard Purchase
- Reading Type: Visual Read
- Sample Type: Nasal Swab Sample
- Specialty: Immunoassay
- Supplier_ID: 4270072
- Test Format: Cassette Format
- Test Kit Type: Rapid
- Test Method: Lateral Flow Chromatographic Immunoassay
- Test Name: COVID-19 Antigen OTC
- Test Type: Antigen Detection
- Time to Results: 15 Minute Results
- UNSPSC Code: 41116205
