Home GUDID 00015482771133 SPOTCHEM™ II Amylase
Primary DI 00015482771133
Brand SPOTCHEM™ II Amylase
Company Arkray USA, Inc.
Model 77113
Device description Strip description for the invitro quantitative determination of amylase concentration in human plasma from whole blood samples
Published 2016-09-23
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use true 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 00015482771133 Primary GS1 0 50015482771138 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00015482771133 00015482771133 015482771133 0015482771133 50015482771138 50015482771138
GMDN Terms# Term, Definition table Term Definition Magnesium (Mg2+) IVD, kit, spectrophotometry A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of magnesium (Mg2+) in a clinical specimen, using a spectrophotometry method.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 0 0
Regulatory Flags# DUNS number 008171162 Device count 25 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false 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 00857969006228 ACE ALFA WASSERMANN, INC. CIJ 2016-09-24 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
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