Procleix NAT Manager

Primary DI
05060496770011
Brand
Procleix NAT Manager
Company
BIOMEDICAL DATA SOLUTIONS LIMITED
Model
1.2
Device description
Procleix NAT Manager Software is designed to collect data from Procleix assays, instruments, and pooling/lysis software, which allows operators to track individual donor blood samples and link them to the appropriate test results. The software collates the results of lysing, pooling and testing, assigns outcomes to individual samples according to a testing algorithm, and formats output files that can be sent to a Laboratory Information Management System (LIMS). Procleix NAT Manager Software also produces a variety of summary informational and analytical reports.
Published
2018-10-02
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
BK1601250

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK1601250

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060496770011PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060496770011050604967700115060496770011

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
05060496770004cobas Synergy12018-09-18
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
05060496770004cobas SynergyBIOMEDICAL DATA SOLUTIONS LIMITEDPQQ2018-09-18