UF-CELLPACK SF

GUDID 84987562433939

UF-CELLPACK SF is a diluent for Sysmex Fully Automated Urine Particle Analyzers and is intended for use only in conjunction with UF-Fluorocell SF. UF-CELLPACK SF is used to mark formed elements in urine (or in body fluid (cerebrospinal fluid, etc.)) for determination of non-nucleated specimens (red blood cells, casts, etc.).

SYSMEX CORPORATION

Buffered sample diluent IVD, automated/semi-automated system
Primary Device ID84987562433939
NIH Device Record Key3199fa05-6404-441c-b2d1-5a774cca883f
Commercial Distribution StatusIn Commercial Distribution
Brand NameUF-CELLPACK SF
Version Model NumberCE604532
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 Volume2.1 Liter
Total Volume2.1 Liter
Total Volume2.1 Liter
Total Volume2.1 Liter
Total Volume2.1 Liter
Total Volume2.1 Liter
Total Volume2.1 Liter
Total Volume2.1 Liter
Total Volume2.1 Liter
Total Volume2.1 Liter
Total Volume2.1 Liter
Total Volume2.1 Liter
Total Volume2.1 Liter
Total Volume2.1 Liter
Total Volume2.1 Liter
Total Volume2.1 Liter
Total Volume2.1 Liter
Total Volume2.1 Liter
Total Volume2.1 Liter
Total Volume2.1 Liter

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
GS104987562433933 [Primary]
GS184987562433939 [Unit of Use]

FDA Product Code

GIFDiluent, Blood Cell

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

On-Brand Devices [UF-CELLPACK SF]

80664369000697A diluent for fully automated urine particle analyzers
84987562433939UF-CELLPACK SF is a diluent for Sysmex Fully Automated Urine Particle Analyzers and is intended

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