Abbott Alinity m HR HPV AMP - HSA Registration DE0507125
Access comprehensive regulatory information for Abbott Alinity m HR HPV AMP 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 DE0507125 and owned by Abbott Molecular Inc. The device was registered on July 29, 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 Alinity m High Risk (HR) HPV assay is a qualitative in vitro test for use with the automated Alinity m System to detect DNA of high-risk HPV genotypes 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68 in clinical specimens. It specifically identifies HPV 16, 18, and 45 while reporting concurrent detection of HPV (31/ 33/ 52/ 58) and HPV (35/ 39/ 51/ 56/ 59/ 66/ 68) at clinically relevant infection levels. The assay is intended for: • Screening patients with ASC-US cervical cytology test results to determine the need for referral to colposcopy. • Used with cervical cytology to adjunctively screen to assess the presence of high-risk HPV. • As a first-line primary screening test to identify women at increased risk for cervical cancer development or presence of high-grade disease. • To assess the presence of HPV 16 and 18 to identify women at increased risk for cervical cancer development or presence of high-grade disease with or without cervical cytology