FDA.reportPublic FDA data

cobas® Microbial Inactivation Solution

Primary DI
07613336146996
Brand
cobas® Microbial Inactivation Solution
Company
Roche Diagnostics GmbH
Model
08185476001
Catalog number
08185476001
Published
2026-03-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JTAMONITOR, MICROBIAL GROWTH

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JTAMonitor, Microbial GrowthMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613336146996PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613336146996076133361469967613336146996

GMDN Terms#

Term, Definition table
TermDefinition
Salmonella paratyphi nucleic acid IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from Salmonella paratyphi bacteria in a clinical specimen.

Regulatory Flags#

DUNS number
315028860
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
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
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
07613336218402Elecsys LH09755721190097557211902026-02-19

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Primary DIBrandCompanyProduct codePublished
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08056040140086URO-QUICK SCREENING KITALIFAX SRLJTA2022-10-06
08056040140291ALFRED 60ALIFAX SRLJTA2022-10-06
08056040140307HB&L UROQUATTROALIFAX SRLJTA2022-10-06
08056040140352ALFRED 60/ASTALIFAX SRLJTA2022-10-06
08056040141168POSITIVE CONTROL KITALIFAX SRLJTA2022-10-06
08056040141182AUTOMATION KITALIFAX SRLJTA2022-10-06
08056040141281URO-QUICK RAA KITALIFAX SRLJTA2022-10-06
08056040141502HB&L UROQUATTRO LIGHTALIFAX SRLJTA2022-10-06
08056040142615RAA BACTERIAL REAGENT PACKALIFAX SRLJTA2022-10-06
00819398026901N/AHARDY DIAGNOSTICSJTA2020-06-04
00819398026918N/AHARDY DIAGNOSTICSJTA2020-06-04
00819398026925N/AHARDY DIAGNOSTICSJTA2020-06-04
00819398026932N/AHARDY DIAGNOSTICSJTA2020-06-03
00819398026949N/AHARDY DIAGNOSTICSJTA2020-06-03
00819398026956N/AHARDY DIAGNOSTICSJTA2020-06-03
00819398026963N/AHARDY DIAGNOSTICSJTA2020-06-03
00819398027168N/AHARDY DIAGNOSTICSJTA2020-06-03
00819398027175N/AHARDY DIAGNOSTICSJTA2020-06-03
00819398021678N/AHARDY DIAGNOSTICSJTA2020-06-02
30382902710562BD BBL™ Venting UnitBECTON, DICKINSON AND COMPANYJTA2018-05-25