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COVID-19 Rapid Test Cassette
HGS GCCOV402A Whole Blood, Serum or Plasma, Test includes: Cassettes, buffer, pipettes and package insert (25 Per Kit)
COVID-19 Rapid Test Cassette
Whole Blood, Serum or Plasma, Test includes: Cassettes, buffer, pipettes and package insert
Current FDA status: EUA for use by authorized moderate & high complexity labs
Not for fingerstick collection
NOT FOR HOME USE
This test has been authorized by FDA under an EUA for use by authorized laboratories
This test has not been FDA cleared or approved
This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens
This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner
Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E
This product is intended for professional use and not for home use
Not for the screening of donated blood
Preorder, Non-Refundable
Features / Benefits
Results in 10 Minutes
Specific to COVID-19 pathogen SARS-CoV-2Specific Volume: 5Microliters (Serum/Plasma), 10 Microliters (Whole Blood)
Detection Window (IgM): Symptomatic 3-5 Days
Storage: 2-30°C
Stability: 24 Months from Date of Manufacturer
Internal Control Included
Use of this test with fingerstick blood is not recommended
Packaged 25 Cassettes/Kit
