FDA.reportPublic FDA data

cobas infinity POC

Primary DI
07613336175385
Brand
cobas infinity POC
Company
Roche Diagnostics GmbH
Model
09159053001
Catalog number
09159053001
Published
2023-10-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JQPCalculator/data processing module, for clinical use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JQPCalculator/Data Processing Module, For Clinical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613336175385PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613336175385076133361753857613336175385

GMDN Terms#

Term, Definition table
TermDefinition
Clinical laboratory information system application softwareAn application software program, routines, and/or algorithms used as or in an information system to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the administrative and clinical activities associated with clinical laboratory services and facilities. It is typically supplied for installation into a dedicated information system used in the clinical laboratory or existing mainframe or decentralized computers/networks.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315028860
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613336235546PreciControl HIV Gen II09465006160094650061602026-05-22
07613336234457PreciControl Syphilis09465022190094650221902026-05-15
07613336231432Tina-quant Antistreptolysin-O II09537368190095373681902026-05-08
07613336231449Tina-quant Antistreptolysin-O II09537341190095373411902026-05-08
07613336154342Elecsys Anti-HBc IgM11820567160118205671602017-09-29
07613336217832Elecsys Testosterone II09745963190097459631902026-04-21
07613336153932Elecsys Anti-HBc IgM07026811160070268111602018-03-19
00875197004748cobas® HBV/HCV/HIV-1 Control Kit1.0069988871902015-12-04
07613336203606Elecsys Anti-HBc II09014918160090149181602022-04-11
07613336203613Elecsys Anti-HBc II09014926160090149261602022-04-11
04015630938858Elecsys AntiHAV IgM11820591160118205911602016-09-20
04015630939855Elecsys Anti-HAV IgM07026773190070267731902017-09-07
07613336224397cobas ISE neo 1800 analytical unit09687416001096874160012026-04-03
20875197004766cobas&#x00AE MPX (96 tests)06998909190069989091902017-02-14
00875197004779cobas&#x00AE MPX (480 tests)06998917190069989171902017-02-14
07613336146996cobas® Microbial Inactivation Solution08185476001081854760012026-03-26
07613336200544cobas c 703 analytical unit09502971001095029710012026-03-20
07613336220191cobas pro SBL c 70309796754001097967540012026-03-20
07613336222331ISE Internal Standard Gen.2 conc.09137742190091377421902026-03-20
04015630926091Testosterone II CalSet II05202230190052022301902026-02-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810142374064SoftBiobankSCC SOFT COMPUTERJQP2026-05-05
00810142373975SoftBiochemistrySCC SOFT COMPUTERJQP2026-04-16
00810142373982SoftCytogeneticsSCC SOFT COMPUTERJQP2026-04-16
00810142373999SoftPathDxSCC SOFT COMPUTERJQP2026-04-16
00810142374002SoftFlowCytometrySCC SOFT COMPUTERJQP2026-04-16
00810142374019SoftHLASCC SOFT COMPUTERJQP2026-04-16
00810142374026SoftMolecularSCC SOFT COMPUTERJQP2026-04-16
00810142374033SoftGenomicsSCC SOFT COMPUTERJQP2026-04-16
00810142374040SoftTrackSCC SOFT COMPUTERJQP2026-04-16
00810142373586SoftTotalQCSCC SOFT COMPUTERJQP2026-03-28
00810142373715SoftBiochemistrySCC SOFT COMPUTERJQP2026-03-12
00810142373722SoftCytogeneticsSCC SOFT COMPUTERJQP2026-03-12
00810142373739SoftPathDxSCC SOFT COMPUTERJQP2026-03-12
00810142373746SoftFlowCytometrySCC SOFT COMPUTERJQP2026-03-12
00810142373753SoftHLASCC SOFT COMPUTERJQP2026-03-12
00810142373760SoftMolecularSCC SOFT COMPUTERJQP2026-03-12
00810142373777SoftGenomicsSCC SOFT COMPUTERJQP2026-03-12
00810142373784SoftTrackSCC SOFT COMPUTERJQP2026-03-12
00810142373340SoftTotalQCSCC SOFT COMPUTERJQP2026-03-11
00810142373593SoftBiochemistrySCC SOFT COMPUTERJQP2026-02-21
00810142373609SoftCytogeneticsSCC SOFT COMPUTERJQP2026-02-21
00810142373616SoftPathDxSCC SOFT COMPUTERJQP2026-02-21
00810142373623SoftFlowCytometrySCC SOFT COMPUTERJQP2026-02-21
00810142373630SoftHLASCC SOFT COMPUTERJQP2026-02-21
00810142373647SoftMolecularSCC SOFT COMPUTERJQP2026-02-21
00810142373654SoftGenomicsSCC SOFT COMPUTERJQP2026-02-21
00810142373661SoftTrackSCC SOFT COMPUTERJQP2026-02-21
00810142373500SoftBiochemistrySCC SOFT COMPUTERJQP2026-02-04
00810142373517SoftCytogeneticsSCC SOFT COMPUTERJQP2026-02-04
00810142373524SoftPathDxSCC SOFT COMPUTERJQP2026-02-04