FDA.reportPublic FDA data

Antisera matrix (non-reactive) IVD, control

Definition
A material consisting of antisera matrix but containing no active immunoglobulins that is intended be used as a negative control to verify the performance of an assay when testing a clinical specimen for red blood cell antigens.
GUDID devices
9
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
05060242472473ALBAcheck - BGS Monoclonal ControlALBA BIOSCIENCE LIMITEDZ271U2020-06-19
10758750003419ORTHOORTHO-CLINICAL DIAGNOSTICS, INC.7154802016-08-24
10758750005949MTSMICRO TYPING SYSTEMS, INCMTS0810012016-08-24
05060242472459ALBAcheck - BGS Monoclonal ControlALBA BIOSCIENCE LIMITEDZ271U2020-06-19
05060242471513ALBAcheck BGS Reagent Control for Anti-DALBA BIOSCIENCE LIMITEDZ271U2014-11-28
23661562105438Neg ControlDIAGAST2105432018-05-01
23661562173178Beckman Coulter® PK® Systems ControlDIAGAST173172016-01-12
07611969950874Seraclone Control AB0+RhBio-Rad Medical Diagnostics GmbH8051711002016-08-15
07611969952212IH-Card ControlBio-Rad Medical Diagnostics GmbH8136001002017-01-20