FDA.reportPublic FDA data

Endogenous DNA internal control reagent IVD

Definition
A substance or reactant intended to be used as an endogenous component in a molecular assay to verify the extraction and/or amplification process applied to target deoxyribonucleic acid (DNA), and/or verify the absence of inhibiting substances, in a clinical specimen.
GUDID devices
10
Last updated
2020-04-28 02:06:57

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00840487101049MHV DNA Sample Processing ControlLUMINEX CORPORATION37002016-12-16
00840487101056MHV DNA Sample Processing ControlLUMINEX CORPORATION3700-022016-12-16
00840487101063MHV DNA Sample Processing ControlLUMINEX CORPORATION3700-212016-12-16
00840487101070MHV DNA Sample Processing ControlLUMINEX CORPORATION3700-222016-12-16
00840487101087MHV DNA Sample Processing ControlLUMINEX CORPORATION37102016-12-16
00840487101094MHV DNA Sample Processing ControlLUMINEX CORPORATION3710-212016-12-16
00840487101100MHV DNA Amplification ControlLUMINEX CORPORATION36942016-12-16
00840487101117MHV DNA Amplification ControlLUMINEX CORPORATION3694-212016-12-16
00840487101124MHV DNA Amplification ControlLUMINEX CORPORATION3694-222016-12-16
00884999031357AbbottABBOTT MOLECULAR INC.8L49-0302017-12-15