FDA.reportPublic FDA data

CELLTRACKS ANALYZER II

Primary DI
10888385000627
Brand
CELLTRACKS ANALYZER II
Company
MENARINI SILICON BIOSYSTEMS, INC.
Model
9555R
Catalog number
9555R
Device description
CellTracks Analyzer II - Refurbished
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
10888385000627PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088838500062710888385000627

GMDN Terms#

Term, Definition table
TermDefinition
Fluorescent immunoassay analyser IVD, laboratory, semi-automatedA stationary mains electricity (AC-powered) laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers in a clinical specimen. The instrument detects fluorescent markers that result from an immunological reaction between the reagents and the specimen, and typically includes an autosampler, reagent dispenser, light source, filter or monochromator, a fluorescent detection system (fluorometer or spectrofluorometer), data processing and/or data display software. The device operates with reduced technician involvement and automation of some, but not all, procedural steps.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Fragile.
Storage Environment Temperature2 Degrees Celsius50 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
057722858
Device count
1
Serial number
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
10888385000016CellSearch790000179000012016-09-22
10888385000023CellSearch790000379000032016-09-22
10888385000030CellSave9528209528202016-09-22
10888385000047CellSave790000579000052016-09-22
10888385000054CELLTRACKS ANALYZER II955595552016-09-22
10888385000085CELLTRACKS ANALYZER II954295422016-09-22

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
10888385000016CellSearchMENARINI SILICON BIOSYSTEMS, INC.NQI2016-09-22
10888385000054CELLTRACKS ANALYZER IIMENARINI SILICON BIOSYSTEMS, INC.NQI2016-09-22
10888385000085CELLTRACKS 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