FDA.reportPublic FDA data

Roche 9180 Electrolyte Analyzer

Primary DI
04015630031832
Brand
Roche 9180 Electrolyte Analyzer
Company
Roche Diagnostics GmbH
Model
3157334001
Catalog number
3157334001
Published
2016-09-20
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
JFPELECTRODE, ION SPECIFIC, CALCIUM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JFPElectrode, Ion Specific, CalciumClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630031832PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630031832040156300318324015630031832

GMDN Terms#

Term, Definition table
TermDefinition
Ion-selective analyser IVDAn electrically-powered automated or semi-automated laboratory instrument intended to be used for the quantitative measurement of electrolytes and/or other ions in a clinical specimen using ion-specific membranes to selectively measure electrical potential against a reference electrode to determine the target ion concentration.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315028860
Device count
1
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
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
00811403010028SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+Diamond Diagnostics Inc.JFP2023-06-05
00811403015870Daily Rinse KitDiamond Diagnostics Inc.JFP2023-06-05
00811403019892SmartLyte Electrolyte AnalyzerDiamond Diagnostics Inc.JFP2023-06-05
00630414606095epoc NXS HostEpocal IncJFP2020-06-18
10054749005519i-STATABBOTT POINT OF CARE INC.JFP2020-05-01
00386100003630pH/pCO2/pO2/Na/K/Cl AnalyzerMEDICA CORPORATIONJFP2018-12-05
00386100002398Daily Cleaning Solution Kit MEDICA CORPORATIONJFP2018-12-04
00386100002893Calcium Na/K/Ca/pH AnalyzerMEDICA CORPORATIONJFP2018-12-04
00386100003067Na/K/Ca/pH Solution Pack MEDICA CORPORATIONJFP2018-12-04
00386100003111Na/K/Ca/pH Solution PackMEDICA CORPORATIONJFP2018-12-04
00386100003296Daily Rinse/Cleaning Solution Kit MEDICA CORPORATIONJFP2018-12-04
00856522006118CC CartridgeLifehealthJFP2018-04-23
08426950807575GEM Premier 5000 PAK BG/ISE/COOX 600 TESTINSTRUMENTATION LABORATORY COMPANYJFP2018-01-24
08426950807582GEM Premier 5000 PAK BG/ISE/COOX/TBILI 600 TESTINSTRUMENTATION LABORATORY COMPANYJFP2018-01-24
08426950807599GEM Premier 5000 PAK BG/ISE/GL/COOX 600 TESTINSTRUMENTATION LABORATORY COMPANYJFP2018-01-24
08426950807605GEM Premier 5000 PAK BG/ISE/GL/COOX/TBILI 600 TESTINSTRUMENTATION LABORATORY COMPANYJFP2018-01-24
08426950807612GEM Premier 5000 PAK BG/ISE/COOX 75 TESTINSTRUMENTATION LABORATORY COMPANYJFP2018-01-24
08426950807629GEM Premier 5000 PAK BG/ISE/COOX/TBILI 75 TESTINSTRUMENTATION LABORATORY COMPANYJFP2018-01-24
08426950807636GEM Premier 5000 PAK BG/ISE/GL/COOX 75 TESTINSTRUMENTATION LABORATORY COMPANYJFP2018-01-24
08426950807643GEM Premier 5000 PAK BG/ISE/GL/COOX/TBILI 75 TESTINSTRUMENTATION LABORATORY COMPANYJFP2018-01-24
08426950807674GEM Premier 5000 PAK BG/ISE/COOX 150 TESTINSTRUMENTATION LABORATORY COMPANYJFP2018-01-24
08426950807681GEM Premier 5000 PAK BG/ISE/COOX/TBILI 150 TESTINSTRUMENTATION LABORATORY COMPANYJFP2018-01-24
08426950807698GEM Premier 5000 PAK BG/ISE/GL/COOX 150 TESTINSTRUMENTATION LABORATORY COMPANYJFP2018-01-24
08426950807704GEM Premier 5000 PAK BG/ISE/GL/COOX/TBILI 150 TESTINSTRUMENTATION LABORATORY COMPANYJFP2018-01-24
08426950807735GEM Premier 5000 PAK BG/ISE/COOX 300 TESTINSTRUMENTATION LABORATORY COMPANYJFP2018-01-24
08426950807742GEM Premier 5000 PAK BG/ISE/COOX/TBILI 300 TESTINSTRUMENTATION LABORATORY COMPANYJFP2018-01-24
08426950807759GEM Premier 5000 PAK BG/ISE/GL/COOX 300 TESTINSTRUMENTATION LABORATORY COMPANYJFP2018-01-24
08426950807766GEM Premier 5000 PAK BG/ISE/GL/COOX/TBILI 300 TESTINSTRUMENTATION LABORATORY COMPANYJFP2018-01-24
08426950807797GEM Premier 5000 PAK BG/ISE/COOX 450 TESTINSTRUMENTATION LABORATORY COMPANYJFP2018-01-24
08426950807803GEM Premier 5000 PAK BG/ISE/COOX/TBILI 450 TESTINSTRUMENTATION LABORATORY COMPANYJFP2018-01-24