FDA.reportPublic FDA data

CellSearch

Primary DI
10888385000016
Brand
CellSearch
Company
MENARINI SILICON BIOSYSTEMS, INC.
Model
7900001
Catalog number
7900001
Device description
Circulating Tumor Cell Kit (Epithelial)
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NQISYSTEM, IMMUNOMAGNETIC, CIRCULATING CANCER CELL, ENUMERATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NQISystem, Immunomagnetic, Circulating Cancer Cell, EnumerationImmunology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888385000016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088838500001610888385000016

GMDN Terms#

Term, Definition table
TermDefinition
Multiple CD cell marker IVD, kit, enzyme immunohistochemistryA collection of reagents and other associated materials 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, calculated scores, and/or enumeration of specific cell populations, using an enzyme immunohistochemistry method. It is used as an aid in the diagnosis/prognosis of conditions associated with different CD cell markers (e.g., colon cancer).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Protect reagents from exposure to sunlight.
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(877)837-4339xx@xx.xx

Regulatory Flags#

DUNS number
057722858
Device count
1
DM exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10888385000061CELLTRACKS AUTOPREP954195412016-09-22
10888385000078CELLTRACKS AUTOPREP790100379010032016-09-22
10888385000610CELLTRACKS AUTOPREP9541R9541R2016-09-22
10888385000665CELLTRACKS AUTOPREP954195412020-07-10
10888385000658CELLTRACKS ANALYZER II955595552020-07-10
10888385000023CellSearch790000379000032016-09-22
10888385000030CellSave9528209528202016-09-22
10888385000047CellSave790000579000052016-09-22
10888385000054CELLTRACKS ANALYZER II955595552016-09-22
10888385000085CELLTRACKS ANALYZER II954295422016-09-22
10888385000627CELLTRACKS ANALYZER II9555R9555R2016-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00041520113429Care One Ahold U.S.A., Inc.NQI2021-08-26
10888385000658CELLTRACKS ANALYZER IIMENARINI SILICON BIOSYSTEMS, INC.NQI2020-07-10
10888385000665CELLTRACKS AUTOPREPMENARINI SILICON BIOSYSTEMS, INC.NQI2020-07-10
10888385000054CELLTRACKS ANALYZER IIMENARINI SILICON BIOSYSTEMS, INC.NQI2016-09-22
10888385000085CELLTRACKS ANALYZER IIMENARINI SILICON BIOSYSTEMS, INC.NQI2016-09-22
10888385000627CELLTRACKS ANALYZER IIMENARINI SILICON BIOSYSTEMS, INC.NQI2016-09-22
10888385000061CELLTRACKS AUTOPREPMENARINI SILICON BIOSYSTEMS, INC.NQI2016-09-22
10888385000078CELLTRACKS AUTOPREPMENARINI SILICON BIOSYSTEMS, INC.NQI2016-09-22
10888385000610CELLTRACKS AUTOPREPMENARINI SILICON BIOSYSTEMS, INC.NQI2016-09-22