COULTER LH Series Retic Pak Reagent Kit 8547196

GUDID 15099590250973

COULTER LH Series Retic Pak Reagent Kit

Beckman Coulter, Inc.

Reticulocyte count IVD, reagent Reticulocyte count IVD, reagent Reticulocyte count IVD, reagent Reticulocyte count IVD, reagent Reticulocyte count IVD, reagent Reticulocyte count IVD, reagent Reticulocyte count IVD, reagent Reticulocyte count IVD, reagent Reticulocyte count IVD, reagent Reticulocyte count IVD, reagent Reticulocyte count IVD, reagent Reticulocyte count IVD, reagent Reticulocyte count IVD, reagent
Primary Device ID15099590250973
NIH Device Record Keyd9b45c2b-a961-4f60-a016-d1605884c18d
Commercial Distribution StatusIn Commercial Distribution
Brand NameCOULTER LH Series Retic Pak Reagent Kit
Version Model Number8547196
Catalog Number8547196
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
GS115099590250973 [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

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