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Intended for Use in the United States INSTRUCTIONS FOR USE shiv VIDEOS Immunodiagnostic Products Anti-HIV 1+2 Reagent Pack 680 1861 Intended Use For the in vitro qualitative detection of antibodies
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The laboratory technician (Laboratory Tech) must be employed by a laboratory licensed by the state in which the results are generated. The results of the anti-HIV 1+2 testing performed at an approved laboratory or provider may be used to identify the serological response to one or more immunization treatments of the HIV geologic category-I antigens. A list of all licensed laboratories that have provided anti-HIV 1+2 testing, immunodiagnostic products, and services will be available by December 31, 2003. Antimalarial 2+2 Reagent Pack Intended for Use in the United States INSTRUCTIONS FOR USE shiv VIDEOS Immunodiagnostic Products Anti-HIV 1+2 Reagent Pack Intended Use For the in vitro qualitative detection of antibodies to Human Immunodeficiency Virus types 1 and/or 2 (anti-HIV-1 and anti-HIV-2) in human serum and plasma (, EDTA or citrate) using the VIDEOS PCI/CIQ Immunodiagnostic System. The results of the immunodiagnostic kits indicated in, for example, the 2+2 Immunodiagnostic Pack may be utilized by health agencies / health care systems, the health care system as well as local health departments in the collection and analysis of data to evaluate the efficacy of immunization programs for prevention of infection with HIV. A list of all licensed laboratories that have provided immunodiagnostic kits indicating their use of the immunodiagnostics of interest or 2+2 Reagent Pack products will be available by December 31, 2003. Immunodiagnostic products for clinical management of HIV and for research may be purchased from authorized health care facilities and research agencies and are not available from laboratory purchase sites. The results of the immunocompetent patients' serological response to the antigens indicated in the product will be used to identify the genotypes of HIV reconversion. The genotype of HIV reconversion is the classification of a person's antibody response to the serologically identified HIV antigens in the form of an antibody tier.

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