510(k) K033106

CAPTIA HSV 2 IGG TYPE SPECIFIC ELISA KIT by Trinity Biotech USA — Product Code MYF

K033106 is an FDA 510(k) premarket notification submitted by Trinity Biotech USA for the device "CAPTIA HSV 2 IGG TYPE SPECIFIC ELISA KIT". The FDA issued a decision of Substantially Equivalent on July 13, 2004. The device falls under product code MYF (Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2), a Class II device regulated under 21 CFR 866.3305. Trinity Biotech USA has at least 10 other 510(k) clearances on record.