FDA.reportPublic FDA data

UF-Fluorocell SF

Primary DI
04987562433957
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
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GJHStain, Reticulocyte

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GJHStain, ReticulocyteHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04987562433957PrimaryGS10
84987562433953Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04987562433957049875624339574987562433957
8498756243395384987562433953

GMDN Terms#

Term, Definition table
TermDefinition
Buffered sample diluent IVDA buffered diluent solution intended to be used as a consumable reagent during manual procedures or on-board an automated or semi-automated instrument (e.g., haematological cell analyser) for the processing, staining and/or testing of clinical laboratory specimens (e.g., whole blood).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume29Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius35 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(888)879-7644crc@sysmex.com

Regulatory Flags#

DUNS number
690664461
Device count
2
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04987562516797CA CAL S014-1271-42024-02-22
04987562205936CA CAL S014127142017-10-06
00664369000899LYSERCELL WDF IICY754019ZA9000142026-04-24
04987562408528UF II CONTROL064041152022-11-30
04987562499700Automated Blood Coagulation Analyzer CN-3000CL971029CL9710292025-12-19
04987562518616Automated Blood Coagulation Analyzer CN-3000BN343315CL9710292025-12-19
14987562460264EIGHTCHECK-3WP140-3004-02016-08-05
14987562460387RANGE CHECK X lll2189812016-08-05
14987562460608plt-CHECK200-4004-02017-10-06
14987562460615plt-CHECK200-4004-12017-10-06
04987562518654Automated Blood Coagulation Analyzer CS-5100CU624138BY9907572024-02-22
04987562518661Automated Blood Coagulation Analyzer CS-2500AG528355BV9817982024-02-22
04987562518678Automated Blood Coagulation Analyzer CA-600 series CA-620CM217273BR1426262024-02-22
04987562518685Automated Blood Coagulation Analyzer CA-600 series CA-660CA174898CK9782892024-02-22
04987562425426Automated Blood Coagulation Analyzer CS-5100BY990757BY9907572016-08-05
04987562425686Automated Blood Coagulation Analyzer CA-600 series CA-620BR142626BR1426262016-08-04
04987562425716Automated Blood Coagulation Analyzer CA-600 series CA-660CK978289CK9782892016-08-05
04987562433735Automated Blood Coagulation Analyzer CS-2500BV981798BV9817982016-09-16
04987562499687Automated Blood Coagulation Analyzer CN-6000CV339763CV3397632025-08-22
04987562518630Automated Blood Coagulation Analyzer CN-6000AX801645CV3397632025-08-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380740213558AlinityABBOTT LABORATORIESGJH2025-09-25
00673693090469EprediaRICHARD-ALLAN SCIENTIFIC COMPANYGJH2024-09-05
00380740137007AlinityAbbott Ireland DiagnosticsGJH2023-11-16
04987562433964UF-Fluorocell CRSYSMEX CORPORATIONGJH2022-11-30
84987562433953UF-Fluorocell SFSYSMEX CORPORATIONGJH2022-11-30
84987562433960UF-Fluorocell CRSYSMEX CORPORATIONGJH2022-11-30
00380740001124CELL-DYNABBOTT LABORATORIESGJH2016-09-09
00380740005009CELL-DYNABBOTT LABORATORIESGJH2016-06-06