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Trisomy 21-risk hormone IVD, control

Definition
A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of multiple hormone levels in a clinical specimen, in order to predict the risk of trisomy 21 (Down syndrome) as part of a first or second trimester screening assessment. Hormones assayed may include alpha-fetoprotein (AFP), human chorionic gonadotropin (HCG), pregnancy associated plasma protein A (PAPP-A), estriol and/or inhibin A.
GUDID devices
5
Last updated
2022-10-12 01:43:40

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
05055273217575MATERNAL CONTROL - LEVEL 1 (MATERNAL CONTROL 1)RANDOX LABORATORIES LIMITEDMSS50242022-09-30
05055273217582MATERNAL CONTROL - LEVEL 2 (MATERNAL CONTROL 2)RANDOX LABORATORIES LIMITEDMSS50252022-09-30
05055273217599MATERNAL CONTROL - LEVEL 3 (MATERNAL CONTROL 3)RANDOX LABORATORIES LIMITEDMSS50262022-09-30
00816870020204Monobind Qsure Maternal Control SetMONOBIND, INC.MC-3002019-02-11
00816870020228Monobind Qsure Tumor Marker Control SetMONOBIND, INC.TMC-3002019-02-11