COULTER Lyse S 4 Lytic Reagent 8547146

GUDID 15099590624743

COULTER Lyse S 4 Lytic Reagent (1L )

Beckman Coulter, Inc.

Full blood count IVD, reagent Full blood count IVD, reagent Full blood count IVD, reagent Full blood count IVD, reagent Full blood count IVD, reagent Full blood count IVD, reagent Full blood count IVD, reagent Full blood count IVD, reagent Full blood count IVD, reagent Full blood count IVD, reagent Full blood count IVD, reagent Full blood count IVD, reagent Full blood count IVD, reagent
Primary Device ID15099590624743
NIH Device Record Keyf8c26cdb-c668-4095-a25b-48c851f022a5
Commercial Distribution StatusIn Commercial Distribution
Brand NameCOULTER Lyse S 4 Lytic Reagent
Version Model Number8547146
Catalog Number8547146
Company DUNS008254708
Company NameBeckman Coulter, Inc.
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 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

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS115099590624743 [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 Date2020-09-08
Device Publish Date2020-08-31

On-Brand Devices [COULTER Lyse S 4 Lytic Reagent]

15099590624743COULTER Lyse S 4 Lytic Reagent (1L )
15099590624736COULTER Lyse S 4 Lytic Reagent (5L)

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