Hologic Aptima® HPV 16 18/45 Genotype Assay - HSA Registration DE0507233
Access comprehensive regulatory information for Hologic Aptima® HPV 16 18/45 Genotype Assay in the Singapore medical device market through Pure Global AI's free database. This CLASS C IVD medical device is registered under HSA registration number DE0507233 and owned by Hologic, Inc.. The device was registered on September 05, 2022.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
The Aptima HPV 16 18/45 genotype assay is an in vitro nucleic acid amplification test for the qualitative detection of E6/E7 viral messenger RNA (mRNA) of human papillomavirus (HPV) types 16, 18, and 45 in cervical specimens from women with Aptima HPV assay positive results. The Aptima HPV 16 18/45 genotype assay can differentiate HPV 16 from HPV 18 and/or HPV 45, but does not differentiate between HPV 18 and HPV 45. Cervical specimens in ThinPrep Pap Test vials containing PreservCyt Solution and collected with broom-type or cytobrush/spatula collection devices may be tested with the Aptima HPV 16 18/45 genotype assay. The assay is used with the Panther System.