Description
- CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test is for use under an FDA Emergency Use Authorization (EUA) only:
- The CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test is a lateral flow immunoassay intended for the qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B protein antigens
- 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
- 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
- Easy to use design, effortless self-administration, whether at home or on the go
- Swift Clarity: Receive results rapidly in 10 minutes for early decision-making
Product Specs
| Item Number | 1257160 |
|---|---|
| Catalog Number | ACT21002110 |
| UOM | BX |
| 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 | Combo - OTC |
| Application | Respiratory Test Kit |
| Brand | Tyfast |
| Buy American Act (BAA) Compliant | Yes |
| Contents 1 | (1) Test Cassette, (1) Swab, (1) Tube with Sample Processing Solution, (1) Quick Ref Instructions |
| Country of Origin | United States |
| Manufacturer | CorDx Inc |
| Manufacturer # | ACT21002110 |
| McKesson # | 1257160 |
| Number of Tests | 1 Test per Kit |
| Purchase Program Type | Standard Purchase |
| Reading Type | Visual Read |
| Sample Type | Anterior Nasal Swab Sample |
| Specialty | Immunoassay |
| Test Format | Cassette Format |
| Test Kit Type | Rapid |
| Test Method | Immunochromatographic Membrane Assay |
| Test Name | Flu A/B & COVID-19 At Home Multiplex Rapid Test |
| Time to Results | 10 Minute Results |
| Trade Agreement Act (TAA) Compliant | Yes |
| UNSPSC Code | 41116144 |