FDA.reportPublic FDA data

cobas b 221 GLU/LAC/UREA (BUN) Cassette

Primary DI
04015630018123
Brand
cobas b 221 GLU/LAC/UREA (BUN) Cassette
Company
Roche Diagnostics GmbH
Model
03261085184
Catalog number
03261085184
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
CDSElectrode, Ion Specific, Urea Nitrogen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CDSElectrode, Ion Specific, Urea NitrogenClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630018123PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630018123040156300181234015630018123

GMDN Terms#

Term, Definition table
TermDefinition
Multiple blood gas analyte IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of one or multiple blood gas analytes in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 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
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07613336171516CalSet Calcitonin09005684190090056841902026-06-01
07613336188064Elecsys Calcitonin09005668160090056681602026-06-01
07613336217641Elecsys Anti-TSHR09744819190097448191902026-06-01
07613336218341Elecsys CA 19-909755608190097556081902026-06-01
07613336218389Elecsys Estradiol III09755659190097556591902026-06-01
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00811403011124BUN ReagentDiamond Diagnostics Inc.CDS2023-06-05
10054749005519i-STATABBOTT POINT OF CARE INC.CDS2020-05-01
00385480183420NOVANOVA BIOMEDICAL CORPORATIONCDS2017-04-24
00385480485968STAT PROFILENOVA BIOMEDICAL CORPORATIONCDS2017-04-21
00856522006033H4 CartridgeLifehealthCDS2016-09-24
00385480118026STAT PROFILENOVA BIOMEDICAL CORPORATIONCDS2016-09-22
00385480087964NOVANOVA BIOMEDICAL CORPORATIONCDS2016-09-20
00385480176125NOVANOVA BIOMEDICAL CORPORATIONCDS2016-09-20
00385480359429STAT PROFILENOVA BIOMEDICAL CORPORATIONCDS2016-09-20
00385480374132STAT PROFILENOVA BIOMEDICAL CORPORATIONCDS2016-09-20
00385480375559STAT PROFILENOVA BIOMEDICAL CORPORATIONCDS2016-09-20
00385480375627STAT PROFILENOVA BIOMEDICAL CORPORATIONCDS2016-09-20
00385480420136STAT PROFILENOVA BIOMEDICAL CORPORATIONCDS2016-09-20
00385480420143STAT PROFILENOVA BIOMEDICAL CORPORATIONCDS2016-09-20
00385480420174STAT PROFILENOVA BIOMEDICAL CORPORATIONCDS2016-09-20
00385480420181STAT PROFILENOVA BIOMEDICAL CORPORATIONCDS2016-09-20
00385480485623STAT PROFILENOVA BIOMEDICAL CORPORATIONCDS2016-09-20
00385480539852NovaNOVA BIOMEDICAL CORPORATIONCDS2016-09-20
10385480087961NOVANOVA BIOMEDICAL CORPORATIONCDS2016-09-20
00385480131926NOVANOVA BIOMEDICAL CORPORATIONCDS2016-09-20
00385480131940NOVANOVA BIOMEDICAL CORPORATIONCDS2016-09-20
00385480132039NOVANOVA BIOMEDICAL CORPORATIONCDS2016-09-20
00385480141826NOVANOVA BIOMEDICAL CORPORATIONCDS2016-09-20
00385480142441NOVANOVA BIOMEDICAL CORPORATIONCDS2016-09-20
00385480145756NovaNOVA BIOMEDICAL CORPORATIONCDS2016-09-20
00385480146104NOVANOVA BIOMEDICAL CORPORATIONCDS2016-09-20
00385480148306NOVANOVA BIOMEDICAL CORPORATIONCDS2016-09-20
00385480148443NOVANOVA BIOMEDICAL CORPORATIONCDS2016-09-20
00385480161534NOVANOVA BIOMEDICAL CORPORATIONCDS2016-09-20
00385480165013NOVANOVA BIOMEDICAL CORPORATIONCDS2016-09-20