FDA.reportPublic FDA data

ClearLLab

Primary DI
15099590671013
Brand
ClearLLab
Company
BECKMAN COULTER IRELAND INC.
Model
M
Catalog number
B66812
Device description
ClearLLab M
Published
2017-07-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
PWDFlow Cytometric Test System For Hematopoietic Neoplasms

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PWDFlow Cytometric Test System For Hematopoietic NeoplasmsHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN160047000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN160047000ClearLLab T1, ClearLLab T2, ClearLLab B1, ClearLLab B2, ClearLLab MBeckman Coulter2017-06-29PWD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15099590671013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1509959067101315099590671013

GMDN Terms#

Term, Definition table
TermDefinition
Multiple CD cell marker IVD, antibodyOne or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of multiple cluster of differentiation (CD) cell markers in a clinical specimen, including associated percentage and/or enumeration of specific cell populations.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
985071975
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15099590695743iChemVELOCITYB793192026-04-27
15099590225889AQUIOS CL B301662016-09-23
15099590677466Navios EX10 Color 3 lasersB809102017-07-06
15099590682996Navios EX8 Color 2 lasersB809112017-07-06
15099590683009Navios EX6 Color 2 lasersB809122017-07-06
15099590683245Navios EXACQUISITION NEW USER SOFTWARE V2.0 WIN 7B91237 2017-07-06
15099590683252Navios EX OFFLINE ACQ SINGLE USER SOFTWARE V2.0 WIN 7 B91238 2017-07-06
15099590683269Navios EXOFFLINE ACQ 5 USERS SOFTWARE V2.0 WIN 7 B912392017-07-06
15099590683276Navios EXTETRA SOFTWARE V2.0 NEW USER B91240 2017-07-06
15099590671242DxH 500B40601B406012020-08-31
15099590679781DxH 520B406022019-03-22
10837461001065Iris660-3021660-30212025-04-16
10837461002321Iris800-3215800-32152025-04-16
15099590694968ClearLLab 10CB900022019-04-05
15099590694975ClearLLab 10CB900032019-03-26
15099590694982ClearLLab 10CB998832019-03-26
15099590701475ClearLLab 10CB968052019-03-26
15099590701482ClearLLab 10CB968062019-03-26
15099590701499ClearLLab 10CB968072019-03-26
15099590701505ClearLLab 10CB968082019-03-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15099590694968ClearLLab 10CBECKMAN COULTER IRELAND INC.PWD2019-04-05
15099590694975ClearLLab 10CBECKMAN COULTER IRELAND INC.PWD2019-03-26
15099590694982ClearLLab 10CBECKMAN COULTER IRELAND INC.PWD2019-03-26
15099590701475ClearLLab 10CBECKMAN COULTER IRELAND INC.PWD2019-03-26
15099590701482ClearLLab 10CBECKMAN COULTER IRELAND INC.PWD2019-03-26
15099590701499ClearLLab 10CBECKMAN COULTER IRELAND INC.PWD2019-03-26
15099590701505ClearLLab 10CBECKMAN COULTER IRELAND INC.PWD2019-03-26
15099590670979ClearLLabBECKMAN COULTER IRELAND INC.PWD2017-07-06
15099590670986ClearLLabBECKMAN COULTER IRELAND INC.PWD2017-07-06
15099590670993ClearLLabBECKMAN COULTER IRELAND INC.PWD2017-07-06
15099590671006ClearLLabBECKMAN COULTER IRELAND INC.PWD2017-07-06