Home GUDID 04987270235584 Lumipulse Infectious Diseases Controls
Primary DI 04987270235584
Brand Lumipulse Infectious Diseases Controls
Company FUJIREBIO INC.
Model 235584
Published 2025-07-31
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name OHQ Multi-Analyte Controls Unassayed
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OHQ Multi-Analyte Controls Unassayed Clinical Chemistry 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 04987270235584 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04987270235584 04987270235584 4987270235584
GMDN Terms# Term, Definition table Term Definition Multiple blood-borne virus antigen/antibody IVD, control A material which is used to verify the performance of a number of assays intended to be used for the qualitative and/or quantitative detection of antigens and/or antibodies from one or multiple blood-borne viruses, in a clinical specimen. Viruses intended to be detected may include (but are not limited to) human immunodeficiency virus 1 and 2 (HIV1 and HIV2), Hepatitis B virus, Hepatitis C virus and human T-cell lymphotrophic virus 1 and/or 2 (HTLV1 and/or HTLV2).
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 Premarket exempt true Kit 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 04987270235058 Lumipulse G BRAHMS PCT Immunoreaction Cartridges 235058 2018-04-02 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 04987270230206 Lumipulse G Whole PTH Calibrators 230206 2019-12-18
Other Devices Sharing Product Codes# 
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