Home GUDID 00630414510156 ADVIA® Chemistry PAMY Pancreatic Amylase Reagents
Primary DI 00630414510156
Brand ADVIA® Chemistry PAMY Pancreatic Amylase Reagents
Company Siemens Healthcare Diagnostics Inc.
Model 10315178
Catalog number 1410820
Device description Amylase pancreatic - ADVIA Chem. - RGT - 7x130 tests
Published 2016-09-24
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use false 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 00630414510156 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 00630414510156 00630414510156 630414510156 0630414510156
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).
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Do not freeze Storage Environment Temperature 0 0
Regulatory Flags# DUNS number 064608573 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 00630414124797 ADVIA Centaur® Calibrator D 10311569 10311569 2014-09-24 00630414124933 ADVIA Centaur® Systems, ACS:180® Systems Calibrator D 10311576 10311576 2014-09-24 00630414126319 ADVIA Centaur® Systems, ACS 180® Systems AFP MCM 10311625 10311625 2014-09-24 00630414177335 ADVIA Centaur® AFP 10309980 10309980 2014-09-24 00630414238791 Atellica IM AFP 11202257 11202257 2018-11-14 00630414238807 Atellica IM AFP 11202258 11202258 2018-11-14 00630414597720 Atellica IM AFP MCM 10995443 10995443 2018-11-14 00630414279176 ADVIA Chemistry UCFP 11319151 11319151 2020-03-06 00630414209845 ADVIA® Chemistry MG Magnesium Reagents 10341119 10341119 2020-09-24 00630414474748 ADVIA® Chemistry TIBC Total Iron Binding Capacity Reagents 10309071 10309071 2020-09-24 00630414508399 ADVIA® Chemistry IP Inorganic Phosphorus Reagents 10309503 10309503 2020-09-24 00630414508429 ADVIA® Chemistry MG Magnesium Reagents 10309506 10309506 2020-09-24 00630414561073 ADVIA® Chemistry CHOL_2 Cholesterol_2 Reagent 10376501 10376501 2020-09-24 00630414561974 ADVIA® Chemistry IRON_2 Iron 2 Reagents 10377510 10377510 2020-09-24 00630414279183 ADVIA Chemistry UCFP Calibrator 11319152 11319152 2020-03-06 00842768013836 Dimension Cardiac Troponin-I Flex reagent cartridge 10444905 10444905 2016-09-24 00842768013904 Dimension Cardiac Troponin-I Flex reagent cartridge 10444896 10444896 2016-09-24 00630414008967 ADVIA® Chemistry Enzyme 1 Calibrator 10916057 10916057 2016-09-24 00630414177328 ADVIA Centaur® AFP 10309979 10309979 2014-09-24 00630414553153 ADVIA® Chemistry (AST_c) AST(GOT) Reagents Concentrated 10283343 10283343 2016-09-24
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