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(877) 507-6899 | info@mediu.us
$536.23 $428.99
Sample Type: nasopharyngeal swab specimens
Detection Method: Colloidal Gold
Detection Time: 15 minutes
COVID-19 – Anterior Nasal – 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%
Interim order: IO#326827
All necessary reagents provided and no equipment is needed
Status™ COVID-19/Flu A&B test is a lateral flow immunoassay intended for the in vitro rapid, simultaneous qualitative detection and differentiation of nucleocapsid antigen from SARS-CoV-2, influenza A and/or influenza B directly from nasopharyngeal swab specimens obtained from individuals, who are suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider, within the first five days of onset of symptoms.
Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate, high, or waived complexity tests. This product is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
Specifications:
| Manufacturer # | 33225 |
| Brand | Status™ |
| Manufacturer | LifeSign |
| Country of Origin | United States |
| Application | Rapid Test Kit |
| Contents 1 | (25) Test Devices, (25) Extraction Reagent Capsules, (25) Sterile Swabs, Positive Control Swab, Negative Control Swab, Package Insert, Quick Reference Instruction |
| Number of Tests | 25 Tests |
| Product Dating | McKesson Acceptable Dating: we will ship >= 30 days |
| Reading Type | Visual Read |
| Sample Type | Nasopharyngeal Swab Sample |
| Test Format | Test Device Format |
| Test Method | Lateral Flow Immunoassay |
| Test Name | COVID-19 / Flu A and B |
| Test Type | Antigen Detection |
| Time to Results | 15 Minute Results |
| UNSPSC Code | 41116144 |
| Weight | N/A |
|---|---|
| Package Size | 1 Kit, 12 Kits, 50 Kits, 100 Kits |
Status™ COVID-19/Flu A&B test is a lateral flow immunoassay intended for the in vitro rapid, simultaneous qualitative detection and differentiation of nucleocapsid antigen from SARS-CoV-2, influenza A and/or influenza B directly from nasopharyngeal swab specimens obtained from individuals, who are suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider, within the first five days of onset of symptoms.
Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate, high, or waived complexity tests. This product is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
Specifications:
| Manufacturer # | 33225 |
| Brand | Status™ |
| Manufacturer | LifeSign |
| Country of Origin | United States |
| Application | Rapid Test Kit |
| Contents 1 | (25) Test Devices, (25) Extraction Reagent Capsules, (25) Sterile Swabs, Positive Control Swab, Negative Control Swab, Package Insert, Quick Reference Instruction |
| Number of Tests | 25 Tests |
| Product Dating | McKesson Acceptable Dating: we will ship >= 30 days |
| Reading Type | Visual Read |
| Sample Type | Nasopharyngeal Swab Sample |
| Test Format | Test Device Format |
| Test Method | Lateral Flow Immunoassay |
| Test Name | COVID-19 / Flu A and B |
| Test Type | Antigen Detection |
| Time to Results | 15 Minute Results |
| UNSPSC Code | 41116144 |
| Weight | N/A |
|---|---|
| Package Size | 1 Kit, 12 Kits, 50 Kits, 100 Kits |
