ClearLLab B66810

GUDID 15099590671006

ClearLLab B2

BECKMAN COULTER IRELAND INC.

Multiple CD cell marker IVD, antibody
Primary Device ID15099590671006
NIH Device Record Keyeccab71c-d591-4a59-a429-39feb3fa7623
Commercial Distribution StatusIn Commercial Distribution
Brand NameClearLLab
Version Model NumberB2
Catalog NumberB66810
Company DUNS985071975
Company NameBECKMAN COULTER IRELAND 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 Datefalse
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
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
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
GS115099590671006 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PWDFlow Cytometric Test System For Hematopoietic Neoplasms

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 Date2017-07-06

On-Brand Devices [ClearLLab]

15099590671013ClearLLab M
15099590671006ClearLLab B2
15099590670993ClearLLab B1
15099590670986ClearLLab T2
15099590670979ClearLLab T1

Trademark Results [ClearLLab]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CLEARLLAB
CLEARLLAB
97631282 not registered Live/Pending
Beckman Coulter, Inc.
2022-10-13
CLEARLLAB
CLEARLLAB
87031781 5617876 Live/Registered
BECKMAN COULTER, INC.
2016-05-10

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