FDA.reportPublic FDA data

Total amylase IVD, reagent

Definition
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of total amylase in a clinical specimen.
GUDID devices
23
Last updated
2023-07-28 08:51:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
10673486001129α – AMYLASE LIQUID REAGENT (KINETIC METHOD)TECO DIAGNOSTICSA532-1502023-07-20
10673486001136α – AMYLASE LIQUID REAGENT (KINETIC METHOD) TC MATRIX-240/480TECO DIAGNOSTICSA532-2002023-07-20
10673486001143AMYLASE REAGENT SET (KINETIC METHOD)TECO DIAGNOSTICSA533-602023-07-20
10758750004393VITROSORTHO-CLINICAL DIAGNOSTICS, INC.81127242016-08-23
10758750008513VITROSORTHO-CLINICAL DIAGNOSTICS, INC.12026702016-08-23
00380740161668ARCHITECTAbbott GmbH7D58-222019-11-15
05060500090128Synermed®INFRARED LABORATORY SYSTEMS LLCVI400-R2016-09-20
05060500090135Synermed®INFRARED LABORATORY SYSTEMS LLCVI400-X2016-09-20
05060500090142Synermed®INFRARED LABORATORY SYSTEMS LLCVI400-WK2016-09-20
05060500090159Synermed®INFRARED LABORATORY SYSTEMS LLCVI400-9112016-09-20
05060500090166Synermed®INFRARED LABORATORY SYSTEMS LLCVI400-R2016-09-20
05060500091705Synermed®INFRARED LABORATORY SYSTEMS LLCVI400-12002017-02-28
00857969006228ACEALFA WASSERMANN, INC.SA10042016-09-24
00817274020807JAS DiagnosticsDREW SCIENTIFIC, INC.AMY2-125A2016-09-09
00817274020814JAS DiagnosticsDREW SCIENTIFIC, INC.AMY2-125U2016-09-09
00817274020821JAS DiagnosticsDREW SCIENTIFIC, INC.AMY2-1252016-09-09
00817274020838JAS DiagnosticsDREW SCIENTIFIC, INC.AMY2-1L2016-09-09
00817274020845JAS DiagnosticsDREW SCIENTIFIC, INC.XL-AMY2-302016-09-09
00817274022320JAS DiagnosticsDREW SCIENTIFIC, INC.AMY2-BUP2016-10-19
00817274022771JAS DiagnosticsDREW SCIENTIFIC, INC.AMY2-P1L2018-07-19
00817274022849JAS DiagnosticsDREW SCIENTIFIC, INC.AMY2-BUL2016-10-11
00380740012854ARCHITECTABBOTT LABORATORIES7D58-212016-09-09
00380740135461AlinityAbbott GmbH07P58202018-10-05