Hologic Aptima HPV Assay - HSA Registration DE0506343
Access comprehensive regulatory information for Hologic Aptima HPV 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 DE0506343 and owned by Hologic, Inc.. The device was registered on November 03, 2021.
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 assay is a target amplification nucleic acid probe test for the in vitro qualitative detection of E6/E7 viral messenger RNA (mRNA) from 14 high-risk types of human papillomavirus (HPV) (16/18/31/33/35/39/45/51/52/56/58/59/66/68). The assay does not discriminate between the 14 high-risk types. The assay is indicated for use in screening patients with ASC-US (atypical squamous cells of undetermined significance) Pap test results to determine the need for colposcopy and can be used with cervical cytology to adjunctively screen for high risk HPV types. The assay can be used as a primary screening test, with or without cervical cytology to identify women at increased risk for the development of cervical cancer or presence of high-grade disease. Cervical specimens collected in ThinPrep Pap Test vials containing PreservCyt solution, or with the Aptima Cervical Specimen Collection and Transport Kit, or in SurePath Preservative Fluid can be used.