This product has received FDA EUA Approval for sale in the United States.
Please contact your local STAT Technologies Sales Representative or the Home Office for information on purchasing.
COVID-19 IgG IgM Product Insert
FDA EUA Approval Letter
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
- 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. This test is approved for use by Medical Professionals Only