Device typeTotal human chorionic gonadotropin IVD, kit, chemiluminescent immunoassay: A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total human chorionic gonadotropin (HCG), which includes a combination of intact HCG, nicked HCG, alpha-HCG subunits, and beta-HCG subunits, in a clinical specimen using a chemiluminescent immunoassay method. It is used to aid detection of pregnancy, or as a predictive indicator of adverse pregnancy outcomes (e.g., miscarriage) and/or trisomy 21 (Down syndrome).
FDA categorySYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
Device ID00816870022581
Catalog number875-300A
MRI safetyLabeling does not contain MRI Safety Information
Width7.75 Inch