Home GUDID 00857969006228
ACE
Primary DI 00857969006228
Brand ACE
Company ALFA WASSERMANN, INC.
Model SA1004
Catalog number SA1004
Device description Amylase Reagent
Published 2016-09-24
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Product Codes# Code, Name table Code Name CIJ Saccharogenic, Amylase
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class CIJ Saccharogenic, Amylase Clinical Chemistry 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00857969006228 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00857969006228 00857969006228 857969006228 0857969006228
GMDN Terms# Term, Definition table Term Definition Total amylase IVD, reagent 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.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 781990924 Device count 1 Kit true Lot or batch true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00811727016034 Pointe Amylase Reagent HORIBA INSTRUMENTS INCORPORATED CIJ 2021-01-30 00811727015723 Pointe Amylase on BS480 Analyzer HORIBA INSTRUMENTS INCORPORATED CIJ 2020-05-28 00852169008041 ClearChem Diagnostics Inc. Amylase CLEARCHEM DIAGNOSTICS INC. CIJ 2018-04-30 00812137011879 AMYLASE (CNPG3) Reagent Set CLINICAL DIAGNOSTIC SOLUTIONS, INC. CIJ 2016-10-12 00817439020192 Amylase / BS480 Medtest Dx, Inc. CIJ 2016-09-27 00817439020215 Amylase / BS200 Medtest Dx, Inc. CIJ 2016-09-27 00015482771133 SPOTCHEM™ II Amylase ARKRAY USA, INC. CIJ 2016-09-23 00015482771157 SPOTCHEM™ II ALP ARKRAY USA, INC. CIJ 2016-09-23 00015482771164 SPOTCHEM™ II Creatinine ARKRAY USA, INC. CIJ 2016-09-23 EABA40000031 Piccolo Liver Panel Plus ABAXIS, INC. CIJ 2016-09-23 EABA40000291 Piccolo General Chemistry 13 ABAXIS, INC. CIJ 2016-09-23 EABA40000351 Piccolo BioChemistry Panel Plus ABAXIS, INC. CIJ 2016-09-23 EABA40000411 Piccolo AmLyte 13 ABAXIS, INC. CIJ 2016-09-23 05055273200560 AMY RANDOX LABORATORIES LIMITED CIJ 2016-09-09 05055273200577 AMY RANDOX LABORATORIES LIMITED CIJ 2016-09-09 05055273200584 AMY RANDOX LABORATORIES LIMITED CIJ 2016-09-09 05055273200607 AMY RANDOX LABORATORIES LIMITED CIJ 2016-09-09 05055273200645 AMY RANDOX LABORATORIES LIMITED CIJ 2016-09-09 05055273200652 AMY RANDOX LABORATORIES LIMITED CIJ 2016-09-09 05055273200676 AMY RANDOX LABORATORIES LIMITED CIJ 2016-09-09 00811727010285 POINTE SCIENTIFIC Amylase HORIBA INSTRUMENTS INCORPORATED CIJ 2016-08-31 00811727010292 POINTE SCIENTIFIC Amylase HORIBA INSTRUMENTS INCORPORATED CIJ 2016-08-31 00811727010308 POINTE SCIENTIFIC AMYLASE HORIBA INSTRUMENTS INCORPORATED CIJ 2016-08-31 00811727010315 POINTE SCIENTIFIC AMYLASE HORIBA INSTRUMENTS INCORPORATED CIJ 2016-08-31 00811727012562 Pointe Scientfic, Inc. HORIBA INSTRUMENTS INCORPORATED CIJ 2016-08-31 00811727012906 Pointe Scientific HORIBA INSTRUMENTS INCORPORATED CIJ 2016-08-31 00811727013422 POINTE SCIENTIFIC Amylase HORIBA INSTRUMENTS INCORPORATED CIJ 2016-08-31 00811727013835 Pointe Scientific, Inc. HORIBA INSTRUMENTS INCORPORATED CIJ 2016-08-31 00811727014641 Pointe Scientific, Inc. Amylase HORIBA INSTRUMENTS INCORPORATED CIJ 2016-08-31 00811727014931 Pointe Scientific, Inc. Amylase HORIBA INSTRUMENTS INCORPORATED CIJ 2016-08-31