Home GUDID 00842768026461 Dimension Vista® Flex® reagent cartridge E2
Primary DI 00842768026461
Brand Dimension Vista® Flex® reagent cartridge E2
Company Siemens Healthcare Diagnostics Inc.
Model 10489099
Catalog number K6463
Device description LOCI Estradiol Flex® reagent cartridge, 320 Tests
Published 2020-09-24
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 NDR ENZYME IMMUNOASSAY, INHIBIN-A
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NDR Enzyme Immunoassay, Inhibin-A Clinical Chemistry 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00842768026461 Primary GS1 0 00630414005850 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 00842768026461 00842768026461 842768026461 0842768026461 00630414005850 00630414005850 630414005850 0630414005850
GMDN Terms# Term, Definition table Term Definition Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay A collection of reagents and other associated materials intended to be used for the quantitative measurement of the estrogen (oestrogen) hormone estradiol (oestradiol) 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 4 Premarket exempt true 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 00630414482446 ADVIA® Chemistry LIP Lipase Reagents 10311896 10311896 2020-09-24 00630414510149 ADVIA® Chemistry CHE Cholinesterase Reagents 10315176 10315176 2020-09-24 00630414526829 ADVIA® Chemistry TRIG_2 Triglyceride_2 Reagent 10335892 10335892 2020-09-24 00630414553191 ADVIA® Chemistry IP_c Inorganic Phosphorus Reagent, Concentrated 10283347 10283347 2020-09-24 00842768013713 Dimension® CTNI Calibrator 10444986 10444986 2016-09-24 00842768016936 Dimension N-terminal Pro-Brain Natriuretic Peptide reagent cartridge 10444901 10444901 2016-09-24 00630414482385 ADVIA® Chemistry RF Rheumatoid Factor Reagents 10311894 10311894 2016-09-24 00630414513096 ADVIA® Chemistry CA_2 Calcium Reagents (Arsenazo III) 10316612 10316612 2016-09-24 00630414513102 ADVIA® Chemistry CA_2 Calcium_2 Reagents (Arsenazo III) 10341116 10341116 2016-09-24 00630414517742 ADVIA® Chemistry C4 Complement C4 Reagents 10309054 10309054 2016-09-24 00630414590394 ADVIA® Chemistry TRIG_c Reagent 10697575 10697575 2016-09-24 00630414601199 ADVIA® Chemistry Alkaline Phosphatase (ALP_2) Calibrator 10916060 10916060 2016-09-24 00630414947419 ADVIA® Chemistry Albumin BCP Reagents 10711841 10711841 2016-09-24 00630414947426 ADVIA® Chemistry Albumin BCP Calibrator 10711842 10711842 2016-09-24 00630414465401 ADVIA® Chemistry CHE Cholinesterase Reagents 10329639 10329639 2020-09-24 00630414534794 ADVIA® 1800 Analyzer 10315183 10315183 2020-09-24 00630414000510 VERSANT HCV Control 2.0 Kit (LiPA) 10719668 10719668 2017-09-15 00630414454597 ADVIA Centaur® FOL 10331250 10331250 2016-09-24 00630414482309 ADVIA® 1650 Chemistry System Ref. 10309442 10309442 2018-12-01 00630414569277 ADVIA® Chemistry ETOH_2 Ethanol_2 Reagents 10379635 10379635 2016-09-24
Other Devices Sharing Product Codes# 
siemens-healthineers.com
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