BIOMERIEUX MYCOPLASMA IST 3 - HSA Registration DE0506711
Access comprehensive regulatory information for BIOMERIEUX MYCOPLASMA IST 3 in the Singapore medical device market through Pure Global AI's free database. This CLASS B IVD medical device is registered under HSA registration number DE0506711 and owned by BIOMERIEUX S.A.. The device was registered on March 10, 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.
MYCOPLASMA IST 3 is a manual qualitative and semi-quantitative in vitro diagnostic test for the culture, identification,indicative enumeration and antibiotic susceptibility testing of Mycoplasma hominis and Ureaplasma spp. including Ureaplasma parvum and Ureaplasma urealyticum.It is intended as an aid to diagnosis and prediction of treatment response in adults suspected of having urogenital mycoplasma infection, using urethral swabs, vaginal and cervical swabs, semen and male urine samples. This assay is intended for use in clinical laboratories by laboratory health professionals.