FDA.reportPublic FDA data

CELLTRACKS AUTOPREP

Primary DI
10888385000665
Brand
CELLTRACKS AUTOPREP
Company
MENARINI SILICON BIOSYSTEMS, INC.
Model
9541
Catalog number
9541
Device description
CELLTRACKS AUTOPREP - EU ROHS Compliant
Published
2020-07-10
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122821000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122821000CELLTRACKS AUTOPREP SYSTEMVeridex, LLC2012-12-13NQI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888385000665PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088838500066510888385000665

GMDN Terms#

Term, Definition table
TermDefinition
Specimen processing instrument IVD, automatedA mains electricity (AC-powered) instrument or platform intended to be used for the automated pre-analytical preparation of a clinical specimen (excluding specimens for microbial culture), which may include the sampling, diluting, and/or aliquoting of clinical specimens and/or any post-analytical processing required, including labelling, storage and/or location data. The device operates with minimal technician involvement and automation of all procedural steps.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
2153468312jclay@siliconbiosystems.com

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
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
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
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
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