UF-Fluorocell CR

GUDID 84987562433960

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.

SYSMEX CORPORATION

Buffered sample diluent IVD, automated/semi-automated system
Primary Device ID84987562433960
NIH Device Record Keyf504dd1e-7b24-4ec5-a808-e7cd2fa0b85f
Commercial Distribution StatusIn Commercial Distribution
Brand NameUF-Fluorocell CR
Version Model NumberAG792864
Company DUNS690664461
Company NameSYSMEX CORPORATION
Device Count2
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(888)879-7644
Emailcrc@sysmex.com
Phone+1(888)879-7644
Emailcrc@sysmex.com
Phone+1(888)879-7644
Emailcrc@sysmex.com
Phone+1(888)879-7644
Emailcrc@sysmex.com
Phone+1(888)879-7644
Emailcrc@sysmex.com
Phone+1(888)879-7644
Emailcrc@sysmex.com
Phone+1(888)879-7644
Emailcrc@sysmex.com
Phone+1(888)879-7644
Emailcrc@sysmex.com
Phone+1(888)879-7644
Emailcrc@sysmex.com
Phone+1(888)879-7644
Emailcrc@sysmex.com
Phone+1(888)879-7644
Emailcrc@sysmex.com
Phone+1(888)879-7644
Emailcrc@sysmex.com
Phone+1(888)879-7644
Emailcrc@sysmex.com
Phone+1(888)879-7644
Emailcrc@sysmex.com
Phone+1(888)879-7644
Emailcrc@sysmex.com
Phone+1(888)879-7644
Emailcrc@sysmex.com
Phone+1(888)879-7644
Emailcrc@sysmex.com
Phone+1(888)879-7644
Emailcrc@sysmex.com
Phone+1(888)879-7644
Emailcrc@sysmex.com
Phone+1(888)879-7644
Emailcrc@sysmex.com

Device Dimensions

Total Volume29 Milliliter
Total Volume29 Milliliter
Total Volume29 Milliliter
Total Volume29 Milliliter
Total Volume29 Milliliter
Total Volume29 Milliliter
Total Volume29 Milliliter
Total Volume29 Milliliter
Total Volume29 Milliliter
Total Volume29 Milliliter
Total Volume29 Milliliter
Total Volume29 Milliliter
Total Volume29 Milliliter
Total Volume29 Milliliter
Total Volume29 Milliliter
Total Volume29 Milliliter
Total Volume29 Milliliter
Total Volume29 Milliliter
Total Volume29 Milliliter
Total Volume29 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104987562433964 [Primary]
GS184987562433960 [Unit of Use]

FDA Product Code

GJHStain, Reticulocyte

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-08
Device Publish Date2022-11-30

Devices Manufactured by SYSMEX CORPORATION

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04987562201402 - STROMATOLYSER-4DL2022-12-08 The STROMATOLYSER-4DL is a reagent that lyses RBC for determination of 4-part differential count, or 5-part differential count*
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