COULTER AcT 7547175

GUDID 15099590639426

COULTER Ac·T 5diff Cal Calibrator

Beckman Coulter, Inc.

Full blood count IVD, calibrator Full blood count IVD, calibrator
Primary Device ID15099590639426
NIH Device Record Keydead6e0c-3dc9-4d90-abe0-4c0b96f42905
Commercial Distribution StatusIn Commercial Distribution
Brand NameCOULTER AcT
Version Model Number5diff
Catalog Number7547175
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 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS115099590639426 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KRXCalibrator For Cell Indices

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

On-Brand Devices [COULTER AcT]

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15099590576479COULTER Ac·T 5diff Autoloader Hematology Analyzer
15099590576462COULTER Ac·T 5diff Hematology Analyzer
15099590264796COULTER Ac·T diff 2 Analyzer
15099590264734COULTER Ac·T diff Analyzer

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