COULTER ReticPrep 7546978

GUDID 15099590221126

COULTER ReticPrep Reagent Kit

Beckman Coulter, Inc.

Reticulocyte count IVD, reagent
Primary Device ID15099590221126
NIH Device Record Key171fd8ae-96f9-4a95-8968-c43b7341f86f
Commercial Distribution StatusIn Commercial Distribution
Brand NameCOULTER ReticPrep
Version Model Number7546978
Catalog Number7546978
Company DUNS008254708
Company NameBeckman Coulter, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 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 16 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 16 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS115099590221126 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GKZCounter, Differential Cell

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-23

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