FDA.reportPublic FDA data

Exogenous DNA internal control kit IVD

Definition
A collection of reagents and other associated materials intended to be used as an exogenous component in a molecular assay, to verify the extraction and/or amplification process applied to target deoxyribonucleic acid (DNA) and/or to verify the absence of inhibiting substances in a clinical specimen.
GUDID devices
29
Last updated
2022-04-12 07:03:30

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
03661540952258MGB Alert Internal Control Set IC2-B, 480 rxn QTY-25ELITECH GROUP INC.800363-252022-04-04
03661540952265MGB Alert Internal Control Set IC2-B, 480 rxn QTY-100ELITECH GROUP INC.800363-1002022-04-04
03661540952296 MGB Alert Internal Control Set IC2-C -480 rxn QTY-25ELITECH GROUP INC.800432-252022-04-04
03661540952302 MGB Alert Internal Control Set IC2-C -480 rxn QTY-100ELITECH GROUP INC.800432-1002022-04-04
00858637005420D CTRL 1 KitEXACT SCIENCES CORPORATION1003002021-08-27
00858637005437D CTRL 2 KitEXACT SCIENCES CORPORATION1003012021-08-27
00858637005444D CTRL 3 KitEXACT SCIENCES CORPORATION1003032021-08-27
03661540950032MGB Alert Internal Control Set IC2-BH 48 rxnElitechgroup Mdx LLCM8005742020-09-15
03661540950124MGB Alert Internal Control Set IC2-B, 09N38-001Elitechgroup Mdx LLC800430-am2020-09-15
03661540950155MGB Alert Internal Control Set IC1, 09N39-001Elitechgroup Mdx LLC800427-am2020-09-15
03661540950186MGB Alert Internal Control Set IC1-A, 09N40-001Elitechgroup Mdx LLC800495-am2020-09-15
03661540950247MGB Alert Internal Control Set IC2-TElitechgroup Mdx LLCM8005802020-09-15
03661540950254MGB Alert Internal Control Set IC2-T, 09N42-001Elitechgroup Mdx LLCM800580-am2020-09-15
03661540950322MGB Alert Internal Control Set IC2-8 48 rxnElitechgroup Mdx LLCM8006002020-09-15
03661540951237MGB Alert Internal Control Set IC1-L 48 rxnElitechgroup Mdx LLCM8006882020-09-15
03661540951404MGB Alert Internal Control Set IC1 -480rxnElitechgroup Mdx LLC8003602020-09-15
03661540951411MGB Alert Internal Control Set IC2-480 rxnElitechgroup Mdx LLC8003622020-09-15
03661540951428MGB Alert Internal Control Set IC2-B, 480 rxnElitechgroup Mdx LLC8003632020-09-15
03661540951589MGB Alert Internal Control Set IC1 -48rxnElitechgroup Mdx LLC8004272020-09-15
03661540951596MGB Alert Internal Control Set IC2-48rxnElitechgroup Mdx LLC8004292020-09-15
03661540951602MGB Alert® Internal Control Set IC2-B, 48 rxnElitechgroup Mdx LLC8004302020-09-15
03661540951619 MGB Alert Internal Control Set IC2-C -48 rxnElitechgroup Mdx LLC8004312020-09-15
03661540951626 MGB Alert Internal Control Set IC2-C-480 rxnElitechgroup Mdx LLC8004322020-09-15
03661540951633MGB Alert Internal Control Set IC1-V 48 rxnElitechgroup Mdx LLC8004392020-09-15
03661540951640MGB Alert Internal Control Set IC1-A, 48 Rxn Elitechgroup Mdx LLC8004952020-09-15
03661540951657MGB Alert Internal Control Set IC2-H-48 rxnElitechgroup Mdx LLC8004962020-09-15
03661540951862MGB Alert®Internal Control 1C Set, 480 rxnElitechgroup Mdx LLC8003612020-09-15
00858637005079Cologuard DNA Control KitEXACT SCIENCES CORPORATION1000742014-11-17
00875197004458cobas® 4800 Systems Internal Control KitRoche Molecular Systems, Inc.1.02016-09-24