ClearLLab 10C

GUDID 15099590701505

ClearLLab 10C M2 Cell Tube

BECKMAN COULTER IRELAND INC.

Multiple CD cell marker IVD, antibody
Primary Device ID15099590701505
NIH Device Record Key3b0c8739-e37d-4eb9-9205-0bc8a17f224e
Commercial Distribution StatusIn Commercial Distribution
Brand NameClearLLab 10C
Version Model NumberB96808
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 Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS115099590701505 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-03
Device Publish Date2019-03-26

On-Brand Devices [ClearLLab 10C]

15099590701505ClearLLab 10C M2 Cell Tube
15099590701499ClearLLab 10C M1 Cell Tube
15099590701482ClearLLab 10C T Cell Tube
15099590701475ClearLLab 10C B Cell Tube
15099590694982ClearLLab Compensation Beads
15099590694975ClearLLab Control Cells abnormal
15099590694968ClearLLab 10C Control Cells normal

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