Home GUDID 84987562433953 UF-Fluorocell SF
Primary DI 84987562433953
Brand UF-Fluorocell SF
Company SYSMEX CORPORATION
Model CE919553
Device description UF-Fluorocell SF is used to mark formed elements in urine or in body fluids for determination of red blood cells, casts, etc. counts with the Sysmex fully automated urine particle analyzers. UF-Fluorocell SF is intended for use only in conjunction with Sysmex diluent UF-CELLPACK SF.
Published 2022-11-30
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 Product Codes# Code, Name table Code Name GJH Stain, Reticulocyte
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GJH Stain, Reticulocyte Hematology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 04987562433957 Primary GS1 0 84987562433953 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04987562433957 04987562433957 4987562433957 84987562433953 84987562433953
GMDN Terms# Term, Definition table Term Definition Buffered sample diluent IVD, automated/semi-automated system A buffered diluent solution intended to be used as a consumable reagent on-board an automated or semi-automated instrument during the processing, staining and/or testing of clinical laboratory specimens. Some types may, in addition be used for manual procedures.
Device Sizes# Type, Value, Unit table Type Value Unit Total Volume 29 Milliliter
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 2 Degrees Celsius 35 Degrees Celsius
Regulatory Flags# DUNS number 690664461 Device count 2 DM exempt false Premarket exempt true 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 04987562516797 CA CAL S 014-1271-4 2024-02-22 04987562205936 CA CAL S 01412714 2017-10-06 00664369000899 LYSERCELL WDF II CY754019 ZA900014 2026-04-24 04987562408528 UF II CONTROL 06404115 2022-11-30 04987562499700 Automated Blood Coagulation Analyzer CN-3000 CL971029 CL971029 2025-12-19 04987562518616 Automated Blood Coagulation Analyzer CN-3000 BN343315 CL971029 2025-12-19 14987562460264 EIGHTCHECK-3WP 140-3004-0 2016-08-05 14987562460387 RANGE CHECK X lll 218981 2016-08-05 14987562460608 plt-CHECK 200-4004-0 2017-10-06 14987562460615 plt-CHECK 200-4004-1 2017-10-06 04987562518654 Automated Blood Coagulation Analyzer CS-5100 CU624138 BY990757 2024-02-22 04987562518661 Automated Blood Coagulation Analyzer CS-2500 AG528355 BV981798 2024-02-22 04987562518678 Automated Blood Coagulation Analyzer CA-600 series CA-620 CM217273 BR142626 2024-02-22 04987562518685 Automated Blood Coagulation Analyzer CA-600 series CA-660 CA174898 CK978289 2024-02-22 04987562425426 Automated Blood Coagulation Analyzer CS-5100 BY990757 BY990757 2016-08-05 04987562425686 Automated Blood Coagulation Analyzer CA-600 series CA-620 BR142626 BR142626 2016-08-04 04987562425716 Automated Blood Coagulation Analyzer CA-600 series CA-660 CK978289 CK978289 2016-08-05 04987562433735 Automated Blood Coagulation Analyzer CS-2500 BV981798 BV981798 2016-09-16 04987562499687 Automated Blood Coagulation Analyzer CN-6000 CV339763 CV339763 2025-08-22 04987562518630 Automated Blood Coagulation Analyzer CN-6000 AX801645 CV339763 2025-08-22
Other Devices Sharing Product Codes# 
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