COULTER diff Ac•T PAK Reagent Kit 8448344

GUDID 15099590224561

COULTER diff Ac•T PAK Reagent Kit

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 ID15099590224561
NIH Device Record Key3b4bb201-6fd2-4c30-ade8-d115f76c0d5c
Commercial Distribution StatusIn Commercial Distribution
Brand NameCOULTER diff Ac•T PAK Reagent Kit
Version Model Number8448344
Catalog Number8448344
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 Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS115099590224561 [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 diff Ac•T PAK Reagent Kit]

15099590625818COULTER diff Ac•T PAK Reagent Kit (15 L)
15099590224561COULTER diff Ac•T PAK Reagent Kit

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