Description
Description
NAME AND INTENDED USE
The GS HIV-2 EIA is an enzyme immunoassay for the detection of circulating antibodies to Human Immunodeficiency Virus Type 2 (HIV-2) in human serum or plasma and is indicated as an aid in the diagnosis of infection with Human Immunodeficiency Virus Type 2 (HIV-2).
The GS HIV-2 EIA is intended for manual use and also for use with the EVOLIS Automated Microplate System as an aid in the diagnosis of infection with HIV-2, or for follow-up testing for HIV-2 antibodies in blood donors.
WARNINGS FOR USERS
For In Vitro Diagnostic Use
WARNING: FDA has licensed this test for use with serum and plasma specimens only. Use of this licensed test kit with specimens other than those specifically approved for use with this test kit may result in inaccurate test results.
PRODUCT DESCRIPTION
The GS HIV-2 EIA is an enzyme immunoassay for the detection of circulating antibodies to human immunodeficiency virus type 2 (HIV-2) in human serum or plasma and is indicated as an aid in the diagnosis of infection with HIV-2.
The GS HIV-2 EIA is intended for manual use and also for use with the EVOLIS Automated Microplate System as an aid in the diagnosis of infection with HIV-2 or for follow-up testing for HIV-2 antibodies in blood donors.
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