FDA.reportPublic FDA data

Multiple immunohaematology test IVD, control

Definition
A collection of reagent red blood cells and/or immunoglobulins directed at red blood cell antigens that are supplied together and intended to be used when testing a clinical specimen to verify the performance of multiple immunohaematological tests.
GUDID devices
29
Last updated
2026-06-18 06:05:15

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
05060242471353ALBAsure QC KitALBA BIOSCIENCE LIMITEDZ481U2015-07-15
05060242473067Ortho™ Confidence Manual SystemALBA BIOSCIENCE LIMITED61411232026-03-12
10758750007554ORTHOORTHO-CLINICAL DIAGNOSTICS, INC.69020962016-08-24
05055273215618HAEMATOLOGY CONTROL - LEVEL 1 (HAEM CNTL - LEVEL 1)RANDOX LABORATORIES LIMITEDHM101902019-06-03
05055273215625HAEMATOLOGY CONTROL - LEVEL 2 (HAEM CNTL - LEVEL 2)RANDOX LABORATORIES LIMITEDHM101912019-06-03
05055273215632HAEMATOLOGY CONTROL - LEVEL 3 (HAEM CNTL - LEVEL 3)RANDOX LABORATORIES LIMITEDHM101922019-06-03
07640137341381DG Gel Essential ControlMedion Grifols Diagnostics AG2x2x6ml2019-04-23
10888234000181CheckcellIMMUCOR, INC.00022242016-04-15
10888234000198CheckcellIMMUCOR, INC.00022252016-04-15
10888234000204Checkcell (Weak)IMMUCOR, INC.00022262016-04-15
10888234000211Checkcell (Weak)IMMUCOR, INC.00022272016-04-15
10888234000334corQC Test SystemIMMUCOR, INC.00024002016-04-14
10888234000341corQC EXTEND 1, 2, and 3IMMUCOR, INC.00024172016-04-14
10888234000372Weak D CellsIMMUCOR, INC.00029952016-04-15
10888234001089Monoclonal ControlIMMUCOR, INC.00660892016-04-18
10888234001096WB corQCIMMUCOR, INC.00660902016-04-14
10888234001102DAT Positive Control CellIMMUCOR, INC.00661222016-04-15
10888234001119DAT Positive Control CellIMMUCOR, INC.00661252016-04-15
10888234001324corQC EXTEND StandardIMMUCOR, INC.00662962016-04-14
10888234001331corQC EXTEND CompleteIMMUCOR, INC.00662972016-04-14
10888234001744Gamma-clone ControlIMMUCOR, INC.04204032016-04-18
10888234001751Gamma-clone ControlIMMUCOR, INC.04204102016-04-18
10888234002178Monoclonal ControlIMMUCOR, INC.00660872016-04-18
07611969952335IH-Basic QCBio-Rad Medical Diagnostics GmbH8141711002018-02-28
07611969952342IH-Internal QCBio-Rad Medical Diagnostics GmbH8141721002018-04-05
07640137340582BBQA IIMedion Grifols Diagnostics AG1 kit2016-09-26
07640137340599Coombs Control CellsMedion Grifols Diagnostics AG1 x 10 ml2016-09-26
07640137340605DG Gel Extended ControlMedion Grifols Diagnostics AG4 x 6 ml2016-09-26
00858400005084DailyChek QC KitAmerican National Red Cross5103952016-07-21