Biosys Plus COVID-19 Rapid Antidbody Test

$650.00

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

Out of stock

SKU: COV-BP 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.

BioSys Plus COVID-19 Flyer
Biosys Plus COVID-19 Product Insert
BioSys Plus COVID-19 Rapid Test Patient Fact Sheet
BioSys Plus COVID-19 Rapid Test Healthcare Providers Fact Sheet

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 Alcohol Wipe, 1 Lancet) , (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:

  • ~10 minute time to result
  • Capillary finger stick sample (20 uL)
  • Individually wrapped
  • Visual reading; No instrumentation required
  • Includes: lancet, dropper, alcohol pad
  • Extra-large, easy to read cassette
  • Sensitivity: 93.5%
  • Specificity: 100%
  • Overall Agreement: 97.9%
  • * Emergency Use Authorization * Must be signed to acknowledge the device’s intended use prior to shipping