Rapid Antigen Test, Covid-19 (POC) (CLIA Waived)

$250.00

TEST KIT, GENBODY COVID-19 RAPID ANTIGEN PRO USE (25/KT)

** This item may only ship to a CLIA Waived Certified Facilities * This item is not intended for consumer use **

Features
  • The GenBody COVID-19 Ag Test if for use under an FDA Emergency Use Authorization: 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
  • The GenBody COVID-19 Ag is an immunochromatographic rapid diagnostic test (RDT) intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in Anterior nasal (AN) swab specimens from individuals who are suspected of COVID-19 by their healthcare provider within the first six days of symptom onset, or from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests
  • 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 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 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
  • Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities
  • Negative results should be treated as presumptive and may be confirmed with a molecular assay, if necessary, for patient management
  • 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
  • Negative results should be considered in the context of a patient’s recent exposures, history, and the presence of clinical signs and symptoms consistent with COVID-19
  • The GenBody COVID-19 Ag is intended for use by medical professionals or operators trained in performing tests in point-of-care settings
  • GenBody COVID-19 Ag test allows for near-patient testing without the need for instrumentation or special equipment
Additional Information
Product Name Rapid Antigen Test, Covid-19 (POC) (CLIA Waived)
SKU COVAG025-NU
Price $250.00
Short Description

TEST KIT, GENBODY COVID-19 RAPID ANTIGEN PRO USE (25/KT)

Weight 2.500000
Featured Product No
Manufacturer Sku COVAG025-NU
UOM BX
Package Type BX
Manufacturer GenBody
Compare Products
You have no items to compare.