FDA.reportPublic FDA data

Multiple anaemia-related analyte IVD, control

Definition
A material which is used to verify the performance of one or multiple assays intended to be used for the qualitative and/or quantitative detection of anaemia-related analytes in a clinical specimen, and which together create an anaemia profile. Analytes detected may include (but are not limited to) iron, ferritin, folate (vitamin B9), prealbumin, transferrin and vitamin B12.
GUDID devices
5
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
B085K928M50Audit MicroControls Linearity FLQ Anemia for Roche SystemsAALTO SCIENTIFICK928M-52019-07-23
00847661000891LyphochekBIO-RAD LABORATORIES, INC.5002020-09-14
00847661002086LyphochekBIO-RAD LABORATORIES, INC.500X2020-09-14
B085K948M50Audit MicroControls Linearity FLQ Anemia for Abbott SystemsAALTO SCIENTIFICK948M-52020-06-29
B085K809M50Audit MicroControls Linearity FD Anemia Siemens AtellicaAALTO SCIENTIFICK809M-52018-03-27