SULFOLYSER

GUDID 84987562422971

SULFOLYSER is a reagent for the automated determination of hemoglobin concentration of blood with Sysmex automated hematology analyzers.

SYSMEX CORPORATION

Total haemoglobin (totHb) IVD, reagent
Primary Device ID84987562422971
NIH Device Record Key05d2ab06-7085-421e-a985-be0b3460266f
Commercial Distribution StatusIn Commercial Distribution
Brand NameSULFOLYSER
Version Model NumberBJ350971
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

Device Dimensions

Total Volume1.5 Liter
Total Volume1.5 Liter
Total Volume1.5 Liter
Total Volume1.5 Liter
Total Volume1.5 Liter
Total Volume1.5 Liter
Total Volume1.5 Liter
Total Volume1.5 Liter

Operating and Storage Conditions

Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104987562422975 [Primary]
GS184987562422971 [Unit of Use]

FDA Product Code

GGKProducts, Red-Cell Lysing Products

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 [SULFOLYSER]

80664369200158Reagent for the automated determination of hemoglobin concentration of blood
00664369200169Reagent for the automated determination of hemoglobin concentration of blood
84987562422971SULFOLYSER is a reagent for the automated determination of hemoglobin concentration of blood wit

Trademark Results [SULFOLYSER]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SULFOLYSER
SULFOLYSER
75299880 2162085 Live/Registered
SYSMEX CORPORATION
1997-05-15

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