FDA.reportPublic FDA data

UF-Fluorocell CR

Primary DI
84987562433960
Brand
UF-Fluorocell CR
Company
SYSMEX CORPORATION
Model
AG792864
Device description
UF-Fluorocell CR is used to mark white blood cells, epithelial cells and bacteria, etc. in urine or in body fluids for determination of their counts with Sysmex fully automated urine particle analyzers. UF-Fluorocell CR is intended for use only in conjunction with Sysmex diluent UF-CELLPACK CR.
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

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
04987562433964PrimaryGS10
84987562433960Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04987562433964049875624339644987562433964
8498756243396084987562433960

GMDN Terms#

Term, Definition table
TermDefinition
Buffered sample diluent IVD, automated/semi-automated systemA 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
TypeValueUnit
Total Volume29Milliliter

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

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

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 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 LABORATORIESGJH2023-11-16
04987562433957UF-Fluorocell SFSYSMEX CORPORATIONGJH2022-11-30
04987562433964UF-Fluorocell CRSYSMEX CORPORATIONGJH2022-11-30
84987562433953UF-Fluorocell SFSYSMEX CORPORATIONGJH2022-11-30
00380740001124CELL-DYNABBOTT LABORATORIESGJH2016-09-09
00380740005009CELL-DYNABBOTT LABORATORIESGJH2016-06-06