Home GUDID 04987270231548 Lumipulse B-Amyloid Controls
Primary DI 04987270231548
Brand Lumipulse B-Amyloid Controls
Company FUJIREBIO INC.
Model 231548
Published 2022-03-14
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 04987270231548 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04987270231548 04987270231548 4987270231548
GMDN Terms# Term, Definition table Term Definition Amyloid B component IVD, control A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of amyloid B component in a clinical specimen.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0 Device Size Text, specify 0
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Temperature 2 Degrees Celsius 10 Degrees Celsius Special Storage Condition, Specify 0 0 Right side up with care. No vibration. Storage Environment Temperature 2 Degrees Celsius 10 Degrees Celsius
Regulatory Flags# DUNS number 710873907 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit true 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 04987270235058 Lumipulse G BRAHMS PCT Immunoreaction Cartridges 235058 2018-04-02 04987270235584 Lumipulse Infectious Diseases Controls 235584 2025-07-31 04987270230466 Lumipulse G Dilution Cartridges 230466 2019-12-27 04987270234440 Soda Lime for LUMIPULSE System 234440 2020-01-10 04987270235447 Lumipulse G B-Amyloid 1-42-N Plasma 235447 2025-01-06 04987270235454 Lumipulse G B-Amyloid 1-42-N Plasma Calibrator 235454 2025-01-06 04987270235485 Lumipulse G B-Amyloid Controls (Plasma)-N 235485 2025-01-06 04987270226964 Beckman Coulter PK TP System 226964 PH3000 2016-09-16 04987270234938 Lumipulse G BRAHMS PCT Calibrator Set 234938 2018-04-02 04987270234945 Lumipulse BRAHMS PCT Controls 234945 2018-04-02 04987270234884 Lumipulse G B-Amyloid 1-42 Calibrator Set 234884 2022-10-31 04987270234891 Lumipulse G B-Amyloid 1-40 Calibrator Set 234891 2022-10-31 04987270234907 Lumipulse B-Amyloid Controls 234907 2022-10-31 04987270231432 Lumipulse G B-Amyloid 1-42 Immunoreaction Cartridges 231432 2022-11-10 04987270231753 Lumipulse G B-Amyloid 1-40 Immunoreaction Cartridges 231753 2022-11-10 04987270231869 Lumipulse G SARS-CoV-2 Ag Calibrator Set 231869 2023-02-01 04987270231876 Lumipulse SARS-CoV-2 Ag Controls 231876 2023-02-01 04987270260340 Lumipulse G SARS-CoV-2 Ag Immunoreaction Cartridges 260340 2023-02-01 04987270234259 LUMIPULSE G1200 234259 2019-12-27 04987270230190 Lumipulse G whole PTH Immunoreaction Cartridges 230190 2019-12-18
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