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
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 2 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 008171162 Device count 25 Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 04987486009801 AUTION Check Plus Controls 102478 2020-02-26 04987486001959 S.G. Calibrator H 100672 2017-04-12 04987486053002 S.G. Calibrator H 111581 N/A 2025-12-19 00015482104658 AUTION MAX™ AX-4060 Analyzer 100526 2025-11-07 00015482510060 Assure® Control - Control Solution Level 2 & Level 3 510006 2025-09-26 00015482600501 Assure® Titanium Blood Glucose Test Strips 600050 2025-09-15 00015482601003 Assure® Titanium Blood Glucose Test Strips 600100 2025-09-15 00015482600013 Assure® Titanium Blood Glucose Meter 600001 2025-09-15 10015482600508 Assure® Titanium Blood Glucose Test Strips 600050 2025-09-15 10015482601000 Assure® Titanium Blood Glucose Test Strips 600100 2025-09-15 00015482510046 Assure® Control - Control Solution Level 1 510004 2019-04-01 00015482510053 Assure® Control - Control Solution Level 2 510005 2019-04-01 00015482510077 Assure® Control - Control Solution Level 3 510007 2019-04-01 00015482102913 ASSURE® ID Insulin 1cc Safety Syringe 210291 2016-09-23 00015482102951 ASSURE® ID Insulin 0.5cc Safety Syringe 210295 2016-09-23 00015482511104 GLUCOCARD® W Blood Glucose Monitoring System 511100 2019-04-01 00015482512057 GLUCOCARD® W Blood Glucose Test Strips 512050 2019-04-01 10015482102910 ASSURE® ID Insulin 1cc Safety Syringe 210291 2016-09-23 10015482102958 ASSURE® ID Insulin 0.5cc Safety Syringe 210295 2016-09-23 30015482501779 Assure® Platinum Blood Glucose Meter 501177 2022-06-17
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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