cobas Synergy

Primary DI
05060496770004
Brand
cobas Synergy
Company
BIOMEDICAL DATA SOLUTIONS LIMITED
Model
1
Device description
cobas Synergy Software is software which controls pre-analytic instruments used to manage tubes and pipette liquid sample material to form pools of samples, as a front-end to the cobas® 6800/8800 Systems. cobas Synergy Software is intended for use in plasma fractionation and whole blood testing laboratories. The software is intended to be used by personnel who are trained in its operation and are familiar with the associated assays and instruments.
Published
2018-09-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
PQQData Acquisition Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PQQData Acquisition SoftwareClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK1601130

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK1601130

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060496770004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060496770004050604967700045060496770004

GMDN Terms#

Term, Definition table
TermDefinition
Blood bank information system application softwareAn application software program, routines, and/or algorithms intended to be used as or in an information system to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute administrative and clinical data within blood-bank centres. It accumulates data on blood-donor status and may include algorithms to process blood-bank information. It may perform additional tasks such as autologous and direct unit tracking, cross-match result determination, and/or management of bar-code information and patient history reports. It is typically supplied for installation into a blood bank information system, or mainframe or decentralized computers/networks.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
502054265
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060496770066Ortho Connect3.02020-11-18
05060496770011Procleix NAT Manager1.22018-10-02
05060496770028ORTHO CONNECT2.02018-10-02
05060496770035Sanguin Aurora2.02018-10-23
05060496770059Sanguin Liberty SRIMPORT3.12018-10-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B180BSB01120Bloodstream SoftwareDATA INNOVATIONS LLCPQQ2025-04-29
B180BSB01110Bloodstream SoftwareDATA INNOVATIONS LLCPQQ2023-04-07
B180BSB01100Bloodstream SoftwareDATA INNOVATIONS LLCPQQ2022-05-31
05060496770011Procleix NAT ManagerBIOMEDICAL DATA SOLUTIONS LIMITEDPQQ2018-10-02