COULTER LH 178832

GUDID 15099590317676

COULTER LH 500 Series System

Beckman Coulter, Inc.

Haematological cell analyser IVD, automated Haematological cell analyser IVD, automated Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD Haematological cell analyser IVD
Primary Device ID15099590317676
NIH Device Record Keyde92ca43-4cfa-4ee4-8c81-a7272518f3ac
Commercial Distribution Discontinuation2016-12-31
Commercial Distribution StatusNot in Commercial Distribution
Brand NameCOULTER LH
Version Model Number500
Catalog Number178832
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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS115099590317676 [Primary]

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 Date2019-12-23
Device Publish Date2016-09-23

On-Brand Devices [COULTER LH]

15099590317676COULTER LH 500 Series System
15099590282431COULTER LH 780 System
15099590265045COULTER LH 500 Series System
15099590265038COULTER LH 500 Series System
15099590264772COULTER LH 750 System

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.