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FDA Clears Two Tests - HSV type I and HSV type II
Palm City, FL (December 20, 2016) Awareness Technology, a manufacturer of diagnostic ELISA, Chemiluminescence , Biochemistry, ISE instrumentation, and ELISA reagents, announces; The US Food and Drug Administration (FDA) granted 510(k) clearances to Awareness Technology’s Herpes Simplex Virus test kits. These qualitative tests measure specific IgG in human serum and are used to differentiate between type I and type II when the combined HSV screening test is positive.
Awareness Technology’s tests use enzyme immune assay technology in the standard 96-microwell format with break apart wells for economical use. The new products, which have both been assigned CLIA category (high complexity), compliment the company’s ReQuest ® line of pre-natal screening and infectious disease tests including HSV I &II. Kits have been designed to run at room temperature and use common wash, substrate, and stop solutions as well as uniform incubation timing for ease of automation and integration into panels.
Manufactured in USA under ISO 13485, HSV type I and HSV type II kits contain ready to use reagents and controls with 12 months shelf life.
For more details, contact firstname.lastname@example.org or visit stand Z5.D40 at MEDLAB.
FDA cleared HSV type I and HSV type II are now part of Awareness Technology’s ReQuest brand of ELISA based reagent kits and are available for immediate sale.
ReQuest reagent kits include the following:
Markers for Infectious Diseases
Measles IgG, Measles IgM, Mumps IgG, Mumps IgM, VZV IgG
Serological Markers for TORCH
TOXO IgG, TOXO IgM, Rubella IgG, Rubella IgM, CMV IgG, CMV IgM, HSV1&2 IgG, HSV1 IgG, HSV2 IgG (Now FDA cleared)
Markers for Bacterial Based Infections
Syphilis IgG, H. Pylori IgG