Home GUDID 00851445007044 GENCHEM™ Amylase Reagent
Primary DI 00851445007044
Brand GENCHEM™ Amylase Reagent
Company GENCHEM INC
Model GEN-AMY
Catalog number GEN-AMY
Device description 10/17/2022
Published 2016-09-19
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name JFJ CATALYTIC METHODS, AMYLASE
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class JFJ Catalytic Methods, Amylase Clinical Chemistry 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00851445007044 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 00851445007044 00851445007044 851445007044 0851445007044
GMDN Terms# Term, Definition table Term Definition Alpha-amylase isoenzyme IVD, kit, spectrophotometry A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of an alpha-amylase isoenzyme (e.g., salivary or pancreatic) and/or to determine its enzymatic activity in a clinical specimen, using a spectrophotometry method. This test is typically used to aid the diagnosis and monitoring of various conditions including pancreatic disease, salivary disease, and conditions associated with the overproduction of alpha-amylase (e.g., mental and physical stress, stress-related psychosomatic disorders, fibromyalgia).
Regulatory Flags# DUNS number 193856866 Device count 1 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# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00851445007006 GENCHEM™ Albumin Reagent GEN-ALB GEN-ALB 2016-09-19 00851445007013 GENCHEM™ Albumin Reagent GEN-ALB-G GEN-ALB-G 2016-09-19 00851445007020 GENCHEM™ Alkaline Phosphatase GEN-ALP R1 GEN-ALP R1 2016-09-19 00851445007037 GENCHEM™ Alkaline Phosphatase GEN-ALP R2 GEN-ALP R2 2016-09-19 00851445007099 GENCHEM™Calcium, Azo Dye Reagent GEN-CA3 GEN-CA3 2016-09-19 00851445007211 GENCHEM™ Glucose Oxidase Reagent GEN-GLU3 GEN-GLU3 2016-09-19 00851445007228 GENCHEM™ Glucose Oxidase Reagent GEN-GLU LX GEN-GLU LX 2016-09-19 00851445007235 GENCHEM™ Glucose Reagent GEN-GLU4 GEN-GLU4 2016-09-19 00851445007051 GENCHEM™ AST/SGOT GEN-AST R1 GEN-AST R1 2016-09-19 00851445007068 GENCHEM™Electrode, Ion Specific, Urea Nitrogen (BUN) reagent GEN-BUN LX GEN-BUN LX 2016-09-19 00851445007075 GENCHEM™ Electrode, Ion Specific, Urea Nitrogen (BUN) reagent GEN-BUN3 GEN-BUN3 2016-09-19 00851445007082 GENCHEM™ UREA GEN-BUN R1 GEN-BUN R1 2016-09-19 00851445007105 GENCHEM™ SYNCHRON CX Multi-Analyte Mixture Calibrator 1 GEN-CAL 1 GEN-CAL 1 2016-09-19 00851445007112 GENCHEM™ SYNCHRON CX Multi-Analyte Mixture Calibrator 2 GEN-CAL 2 GEN-CAL 2 2016-09-19 00851445007129 GENCHEM™ SYNCHRON CX Multi-Analyte Mixture Calibrator 3 GEN-CAL 3 GEN-CAL 3 2016-09-19 00851445007136 GENCHEM™ CK-NAC Reagent GEN-CK R1 GEN-CK R1 2016-09-19 00851445007143 GENCHEM™ CK-NAC Reagent GEN-CK R2 GEN-CK R2 2016-09-19 00851445007150 GENCHEM™ CO2 Acid Reagent GEN-CO2ACID GEN-CO2ACID 2016-09-19 00851445007167 GENCHEM™ CO2 Acid Reagent GEN-CO2ALK GEN-CO2ALK 2016-09-19 00851445007174 GENCHEM™ Creatinine Test Reagent GEN-CREA R1(Base) GEN-CREA R1(Base) 2016-09-19
Other Devices Sharing Product Codes# 
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