FDA.reportPublic FDA data

Multiple antinuclear antibody (ANA) screening IVD, control

Definition
A material which is used to verify the performance of a number of assays intended to be used for the qualitative and/or quantitative screening for one or multiple antinuclear antibodies (ANA) in a clinical specimen.
GUDID devices
37
Last updated
2019-11-15 19:30:34

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
M7490202321HEp-2000® Fluorescent ANA-Ro Test SystemIMMUNO CONCEPTS INC2023 (2)2016-09-24
M7490202711HEp-2000® Fluorescent ANA-Ro Test SystemIMMUNO CONCEPTS INC2027 (1)2016-09-24
M7490202911HEp-2000® Fluorescent ANA-Ro Test SystemIMMUNO CONCEPTS INC2029 (1)2016-09-24
M7490020321HEp-2000® Fluorescent ANA-Ro Test SystemIMMUNO CONCEPTS INC20322016-09-24
M7490202611HEp-2000® Fluorescent ANA-Ro Test SystemIMMUNO CONCEPTS INC2026 (1)2016-09-24
M7490203111HEp-2000® Fluorescent ANA-Ro Test SystemIMMUNO CONCEPTS INC2031 (1)2016-09-24
M7490203511HEp-2000® Fluorescent ANA-Ro Test SystemIMMUNO CONCEPTS INC2035 (1)2016-09-24
M7490203711HEp-2000® Fluorescent ANA-Ro Test SystemIMMUNO CONCEPTS INC2037 (1)2016-09-24
M7490204111HEp-2000® Fluorescent ANA-Ro Test SystemIMMUNO CONCEPTS INC2041 (1)2016-09-24
M7490202521HEp-2000® Fluorescent ANA-Ro Test SystemIMMUNO CONCEPTS INC2025 (2)2016-09-24
M7490202111HEp-2000® Fluorescent ANA-Ro Test SystemIMMUNO CONCEPTS INC2021 (1)2016-09-24
M7490202221HEp-2000® Fluorescent ANA-Ro Test SystemIMMUNO CONCEPTS INC2022 (2)2016-09-24
B110ACA10430ANA ACA ControlBion Enterprises, Ltd.ACA-10432016-09-12
B110ANN10100ANA Negative ControlBion Enterprises, Ltd.ANN-10102016-09-12
B110ANP10400ANA Homogeneous ControlBion Enterprises, Ltd.ANP-10402016-09-12
B110NUC10420ANA Nucleolar ControlBion Enterprises, Ltd.NUC-10422016-09-12
B110RNP10440ANA RNP ControlBion Enterprises, Ltd.RNP-10442016-09-12
B110SCL10460ANA Scl-70 ControlBion Enterprises, Ltd.SCL-10462016-09-12
B110SSA10450ANA SSA ControlBion Enterprises, Ltd.SSA-10452016-09-12
B110SSB10470ANA SSB ControlBion Enterprises, Ltd.SSB-10472016-09-12
00845714001932IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.22012016-09-23
00845714001949IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.22022016-09-23
00845714001956IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.22032016-09-23
00845714001963IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.22042016-09-23
00845714001970IMMCO DIAGNOSTICSIMMCO DIAGNOSTICS, INC.22052016-09-23
00847661000082LiquichekBIO-RAD LABORATORIES, INC.1072016-09-12
00847661000099LiquichekBIO-RAD LABORATORIES, INC.1082016-09-12
00847661000105LiquichekBIO-RAD LABORATORIES, INC.1112016-09-12
00847661000112LiquichekBIO-RAD LABORATORIES, INC.1122016-09-12
00847661000129LiquichekBIO-RAD LABORATORIES, INC.1182016-09-12
00847661000204LiquichekBIO-RAD LABORATORIES, INC.1292016-09-12
00847661000211LiquichekBIO-RAD LABORATORIES, INC.1312016-09-19
00847661000228LiquichekBIO-RAD LABORATORIES, INC.1302016-09-12
00847865000055BioPlex 2200BIO-RAD LABORATORIES, INC.66311312016-09-12
00847865000079BioPlex 2200BIO-RAD LABORATORIES, INC.66311412016-09-12
00613745039183ImmunoDOT Serum Control DGenBio800-39182016-09-24
00613745039206ImmunoDOT Negative ControlGenBio800-39202016-09-24