FDA.report

Urea IVD, control

Definition
A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of urea or urea nitrogen [also known as blood urea nitrogen (BUN)] in a clinical specimen.
GUDID devices
11
Last updated
2019-03-30 13:02:16

Related Product Codes

CodeDeviceSpecialtyClassDevices
CDQUrease And Glutamic Dehydrogenase, Urea NitrogenClinical Chemistry211

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
00817274020937JAS DiagnosticsDREW SCIENTIFIC, INC.BUN2-BUP2016-09-09
00817274020944JAS DiagnosticsDREW SCIENTIFIC, INC.BUN2-1L2016-09-09
00817274020951JAS DiagnosticsDREW SCIENTIFIC, INC.BUN2-1LU2016-09-09
00817274020968JAS DiagnosticsDREW SCIENTIFIC, INC.DG-BUN2-1L2016-09-09
00817274020975JAS DiagnosticsDREW SCIENTIFIC, INC.BUN2-125U2016-09-09
00817274020982JAS DiagnosticsDREW SCIENTIFIC, INC.DG-BUN2-1252016-09-09
00817274020999JAS DiagnosticsDREW SCIENTIFIC, INC.BUN2-1252016-09-09
00817274021002JAS DiagnosticsDREW SCIENTIFIC, INC.XL-BUN2-402016-09-09
00817274021019JAS DiagnosticsDREW SCIENTIFIC, INC.XL-BUN2-402016-09-09
00817274021026JAS DiagnosticsDREW SCIENTIFIC, INC.BUN2-BUL2016-09-09
00817274021033JAS DiagnosticsDREW SCIENTIFIC, INC.BUNS-3U2016-09-09