Home GUDID 00842768028519 Dimension Vista® Flex® reagent cartridge CA125
Primary DI 00842768028519
Brand Dimension Vista® Flex® reagent cartridge CA125
Company Siemens Healthcare Diagnostics Inc.
Model 10464357
Catalog number K6455
Device description LOCI CA 125 Flex® reagent cartridge, 160 Tests
Published 2016-09-24
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information 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 00842768028519 Primary GS1 0 00630414005614 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 00842768028519 00842768028519 842768028519 0842768028519 00630414005614 00630414005614 630414005614 0630414005614
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 Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 005088112 Device count 2 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 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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