FDA.reportPublic FDA data

Multiple clinical chemistry enzyme IVD, control

Definition
A material which is used to verify the performance of a number of assays intended to be used for the quantitative measurement of one or multiple clinical chemistry enzymes.
GUDID devices
34
Last updated
2020-10-19 06:38:14

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
04987762129759ISE Buffer (IS)JEOL LTD.7816113342020-10-09
04987762129766Reagent Probe Wash SJEOL LTD.7816114822020-09-15
04987762129773Reagent Probe Wash KJEOL LTD.7816114742020-09-15
04987762129780Reagent Probe Wash 2JEOL LTD.7816114662020-09-15
04987762129797Reagent Probe Wash 1JEOL LTD.7816114582020-09-15
04987762129810Cuvette Conditioner EXJEOL LTD.7816114312020-09-15
04987762129827Cuvette Wash Solution 7JEOL LTD.7816114232020-09-15
04987762129834ISE Detergent SolutionJEOL LTD.7816114152020-09-15
04987762129889ISE Serum Standard Set NAJEOL LTD.7816113512020-09-15
04987762129896Internal StandardJEOL LTD.7816113422020-09-15
04987762129902ISE Urine Standard SetJEOL LTD.7816113692020-09-15
05055273216486ENZYMES LINEARITY VERIFIER (For Roche Systems) (ENZYMES LIN VER ROCHE)RANDOX LABORATORIES LIMITEDLV103662020-07-15
00657498002155Ketone Serum ControlsSTANBIO LABORATORY, L.P.4010-0022019-03-11
00695684131128KETONE SERUM CONTROLSGERMAINE LABORATORIES, INC131122019-02-06
00859110005357ValidateLgc Clinical Diagnostics, Inc.1300au2020-03-02
00859110005364ValidateLgc Clinical Diagnostics, Inc.1300bcc2020-03-02
00859110005371ValidateLgc Clinical Diagnostics, Inc.1300re2020-03-02
00859110005388ValidateLgc Clinical Diagnostics, Inc.1300sa2020-03-02
00859110005395ValidateLgc Clinical Diagnostics, Inc.1300sd2020-03-02
00859110005401ValidateLgc Clinical Diagnostics, Inc.1300vt2020-03-02
00859110005500ValidateLgc Clinical Diagnostics, Inc.104ab2020-03-02
00859110005340ValidateLgc Clinical Diagnostics, Inc.1300ab2020-02-15
00842768004988Dimension® Enzyme VerifierSiemens Healthcare Diagnostics Inc.104450162016-09-24
00852553007049Enzymer Verifier KitVERICHEM LABORATORIES, INC.94302016-11-29
00852553007056Enzymer ER Verifier KitVERICHEM LABORATORIES, INC.94102016-11-29
00852553007131Enzymer ER Verifier, Level GVERICHEM LABORATORIES, INC.94172016-11-29
00816467020136FastPack® Control KitQUALIGEN INC.Multi-Analyte Controls2016-09-16
00817274021163JAS DiagnosticsDREW SCIENTIFIC, INC.CON 2-52016-09-20
00817274022368JAS DiagnosticsDREW SCIENTIFIC, INC.CON 2-5U2016-11-07
00811727010070POINTE SCIENTIFIC Ammonia/Alcohol ControlsHORIBA INSTRUMENTS INCORPORATEDA7504-CTL2016-08-31
00725609000205SPOTCHECKASTORIA-PACIFIC, INC.80-0900-01K2016-10-14
00725609000212SPOTCHECKASTORIA-PACIFIC, INC.80-0901P4K2016-10-14
00725609000441SPOTCHECKASTORIA-PACIFIC, INC.80-0900P4K2016-10-14
00725609000458SPOTCHECKASTORIA-PACIFIC, INC.80-0901-01K2016-10-14