Home GUDID 00630414294278 Atellica IM CA 125II
Primary DI 00630414294278
Brand Atellica IM CA 125II
Company Siemens Healthcare Diagnostics Inc.
Model 11206266
Catalog number 11206266
Device description CA 125II Atellica IM - RGT 500T
Published 2020-05-31
Public version status New
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 LTK TEST, EPITHELIAL OVARIAN TUMOR-ASSOCIATED ANTIGEN (CA125)
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LTK Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) Immunology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00630414293493 Primary GS1 0 00630414294278 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 00630414293493 00630414293493 630414293493 0630414293493 00630414294278 00630414294278 630414294278 0630414294278
GMDN Terms# Term, Definition table Term Definition Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of cancer antigen 125 (CA125), a marker commonly associated with ovarian cancer, in a clinical specimen using a chemiluminescent immunoassay method.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Store upright, Protect from light Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 064608573 Device count 5 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
Other Devices Sharing Product Codes# 
siemens-healthineers.com
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