Assure Tech Co., Ltd. ASSURE COVID-19 IgG/IgM Rapid Test Device

Description

Includes

20 tests/kit, disposable pipettes, sterile safety lancets, alcohol prep pads, buffer. Note: this test requires a control (not included).

Provides results in 15 minutes with 20 tests/kit.

• Highly accurate, easy to use rapid test kit provides results in 15 minutes
• Includes:
  • 20 tests/kit
  • Disposable pipettes
  • Sterile safety lancets
  • Alcohol prep pads
  • Buffer
  • Package Insert
• Intended use:
  
  • Rapid lateral flow chromatographic immunoassay for qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood (sodium EDTA), serum, plasma (sodium EDTA) and fingerstick whole blood
  • Identify individuals with an adaptive immune response to SARS-CoV-2
• Limited use:
  • Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a
• Note:
  • Device should not be used to diagnose acute SARS-CoV-2 infection
  • FDA EUA CLIA Waived authorization- fingerstick blood samples can now be tested in POC (Point of Care) setting such as doctor's offices, hospitals, urgent care centers and emergency rooms rather than having to be sent to a central lab for testing. under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation

Specifications

• Content And Storage: Ambient
• Control Sets: This test requires a control (not included).
• CE Marker: Yes
• Clia Complexity: Waived (FDA, EUA)
• Detectable Analytes: SARS-CoV-2 IgG, IgM
• Sample Type: Human venous whole blood (sodium EDTA), serum, plasma (sodium EDTA) and fingerstick whole blood
• Sensitivity: 100% Combined Sensitivity
• Type: Covid-19 Antibody
• Disposable: Single-use
• Includes: 20 tests/kit, disposable pipettes, sterile safety lancets, alcohol prep pads, buffer, and a Pk. insert
• Quantity: 20 Tests/Kit
• Specificity: Combined specificity 98.8%
• Test Time: 15 min.

FDA EUA CLIA WAIVED