Confirm Biosciences Covid-19 Rapid Antibody Test

$473.75

Covid-19 Rapid Antibody Test
* IN STOCK PLEASE CONTACT FOR INFORMATION ON ORDERING*

 

Out of stock

SKU: HE-Cassette-COVID19 Category:

Description

The FDA policy can be found in the link below and applies to developers of serology tests that identify antibodies (e.g., IgG, IgM) to SARS-CoV-2 from clinical specimens. Unless and until an EUA is issued that authorizes additional testing environments for a specific test, under CLIA, use of that test is limited to laboratories certified to perform high complexity testing, and at the point-of care when covered by the laboratory’s CLIA certificate for high-complexity testing.15 This policy does not apply to at-home testing, including at-home specimen collection, due to additional considerations that require FDA review. https://www.fda.gov/media/135659/download 

Please contact your local STAT Technologies Sales Representative or the Home Office for information on purchasing.

COVID-19 IgG IgM Product Insert
FDA Compliance
Emergency Use Only Authorization Agreement
* Emergency Use Authorization * Must be signed to acknowledge the device’s intended use
Appendix III Clinical Evaluation Report of the In Vitro Diagnostic Reagents
Appendix II Stability Report of the In Vitro Diagnostic Reagents

Unit: 1 Box (25 Tests)
Regulatory Status: Professional Use Only
Contents: (25) Sealed Test Packages (each containing 1 Test Cassette, 1 dropper, 1 desiccant) , (1) Buffer Vial, (1) Package Insert
Determinations: Qualitative and Differential detection of IgG and IgM antibodies to 2019 Novel Coronoavirus
Storage Requirements: 36° – 86° F
Processing Time: Approximately 10 Minutes

Features:

  • Rapid results in 10 minutes
  • Small sample sizes
  • Sold in packs of 25
  • Accuracy over 97% (Clinical Evaluation Report)
  • Following the incubation period, IgM may appear in blood within 3-5 days. IgG will appear as soon as 1-2 weeks.
  • Shelf life of 24 months from manufacture date
  • Forensic/Professional Use Only
  • * Emergency Use Authorization * Must be signed to acknowledge the device’s intended use prior to shipping