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Inherited haemoglobinopathy IVD, control

Definition
A material which is used to verify the performance of an assay intended to be used to evaluate a clinical specimen to diagnose, monitor or predict inherited haemoglobinopathies or haemoglobin variants, which may be associated with HbC (haemoglobin C), HbE, HbS (sickle-cell disease), Hb Lepore, Hb constant spring, alpha-thalassaemia and/or beta-thalassaemia.
GUDID devices
26
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
M52553280AA2 Hemo ControlHELENA LABORATORIES CORPORATION53282016-09-07
M52553290ASA2 Hemo ControlHELENA LABORATORIES CORPORATION53292016-09-07
M52553300AFSA2 Hemo ControlHELENA LABORATORIES CORPORATION53302016-09-07
M52553310AFSC Hemo ControlHELENA LABORATORIES CORPORATION53312016-09-07
M52553330Abnormal HbA2 Quik Column ControlHELENA LABORATORIES CORPORATION53332016-09-07
M52553390Normal HbA2 Quik Column ControlHELENA LABORATORIES CORPORATION53392016-09-07
00847817007170Hemoglobin Variants SystemBIO-RAD LABORATORIES, INC.250-00152020-06-24
00847817007187Hemoglobin Variants SystemBIO-RAD LABORATORIES, INC.250-00162020-06-24
00817869020052Hemoglobin AFSC ControlANALYTICAL CONTROL SYSTEMS INCHC-1022019-01-31
00817869020069Hemoglobin NAFSC ControlANALYTICAL CONTROL SYSTEMS INCHC-102N2019-01-31
00817869020076Hemoglobin AF ControlANALYTICAL CONTROL SYSTEMS INCHC-1032019-01-31
00817869020083Hemoglobin AC ControlANALYTICAL CONTROL SYSTEMS INCHC-1052019-01-31
00817869020090Hemoglobin AS ControlANALYTICAL CONTROL SYSTEMS INCHC-1042019-01-31
00817869020106Hemoglobin AC Control PowderANALYTICAL CONTROL SYSTEMS INCHC-105P2019-01-31
00817869020113Hemoglobin F Normal ControlANALYTICAL CONTROL SYSTEMS INCHC-1062019-01-31
00817869020120Hemoglobin F Abnormal ControlANALYTICAL CONTROL SYSTEMS INCHC-106EL2019-01-31
00817869020168Hemoglobin Total Normal ControlANALYTICAL CONTROL SYSTEMS INCHC-1102019-01-31
00817869020175Hemoglobin Total Linearity ControlANALYTICAL CONTROL SYSTEMS INCHC-110LIN2019-01-31
00817869020182Hemoglobin A2 Normal ControlANALYTICAL CONTROL SYSTEMS INCHC-1112019-01-31
00817869020199Hemoglobin A2 Elevated ControlANALYTICAL CONTROL SYSTEMS INCHC-111EL2019-01-31
00817869020205Hemoglobin AE ControlANALYTICAL CONTROL SYSTEMS INCHC-1172019-01-31
00817869020212Hemoglobin FAS ControlANALYTICAL CONTROL SYSTEMS INCHC-1182019-01-31
00817869020229Hemoglobin AD ControlANALYTICAL CONTROL SYSTEMS INCHC-1202019-01-31
00817869020236HemoglobinAG Philadelphia ControlANALYTICAL CONTROL SYSTEMS INCHC-1272019-01-31
00817869020359Hemoglobin Variant Control KitANALYTICAL CONTROL SYSTEMS INCHC-1212019-11-19
00847817008313VARIANT nbsBIO-RAD LABORATORIES, INC.250-30042016-09-12