STROMATOLYSER-FB

GUDID 00664369200220

Lysing reagent for analysis of basophils and WBC

SYSMEX CORPORATION

Blood cell lysis reagent IVD
Primary Device ID00664369200220
NIH Device Record Key78b6b777-673a-40b6-b73b-721514d88649
Commercial Distribution StatusIn Commercial Distribution
Brand NameSTROMATOLYSER-FB
Version Model NumberFBA-200A
Company DUNS690664461
Company NameSYSMEX CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com
Phone+1(888)879-7639
Emailcrc@sysmex.com

Device Dimensions

Total Volume5 Liter
Total Volume5 Liter
Total Volume5 Liter
Total Volume5 Liter
Total Volume5 Liter
Total Volume5 Liter
Total Volume5 Liter
Total Volume5 Liter
Total Volume5 Liter
Total Volume5 Liter

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100664369200220 [Primary]

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 Date2022-11-14
Device Publish Date2022-11-04

On-Brand Devices [STROMATOLYSER-FB]

00664369200220Lysing reagent for analysis of basophils and WBC
04987562022335STROMATOLYSER-FB is a reagent for analyzing basophil counts and WBC counts by the flow cytometry

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