Respiratory Test Kit OSOM® COVID-19 Antigen 40 Tests
About this item
- OSOM Covid-19 Antigen Rapid Test is for use under an FDA EUA: https://www.fda.gov/medical-devices/covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2
- OSOM® COVID-19 Antigen Rapid Test is a lateral flow chromatographic immunoassay intended for the qualitative detection of the SARS-CoV-2 nucleocapsid protein antigen in direct midturbinate (MT) nasal swab specimens from individuals who are suspected
- Qualitative detection of the SARS-CoV-2 nucleocapsid protein antigen in direct mid-turbinate (MT) nasal swab specimens collected by a healthcare provider from individuals suspected of COVID-19 within the first 7 days of symptom onset when tested at l
- For 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 test 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
- Positive results indicate the presence of viral antigens, but clinical correlation with past medical history and other diagnostic information is necessary to determine patient infection status
- Positive results do not rule out bacterial infection or co-infection with other viruses
- Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities
- 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 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control measures such as isolating from others and wearing masks
Price: Available Upon Quote
50+ In Stock.
RAPID TEST, COVID 19 OSOM ANTIGEN (40/KT 12KT/CS)
Product Specifications:
Manufacturer #: | 1066-40 |
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Brand: | OSOM® |
Manufacturer: | Sekisui Diagnostics |
Country of Origin: | United States |
Application: | Respiratory Test Kit |
Contents 1: | (40) Test Devices containing LFI Test Strip in Plastic Housing, 2 X (20) Nasal Swab Specimen Collection and Dispensing Tubes with OSOM Antigen Buffer, IFU, Quick Ref Guide |
Number of Tests: | 40 Tests |
Product Dating: | McKesson Acceptable Dating: we will ship >= 60 days |
Purchase Program Type: | Standard Purchase |
Reading Type: | Visual Read |
Sample Type: | Direct Mid-Turbinate Nasal Swab Sample |
Specialty: | Immunoassay |
Test Format: | Test Device Format |
Test Kit Type: | Rapid |
Test Method: | Lateral Flow Chromatographic Immunassay |
Test Name: | Covid-19 Antigen |
Time to Results: | 15 Minute Results |