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
07613336217702Elecsys T309744975190097449751902026-09-04
07613336246672Elecsys Anti-HBc II09745009160097450091602026-09-04
07613336172827Elecsys DHEA-S II09043551190090435511902026-08-07
07613336172834Elecsys DHEA-S II09043560190090435601902026-08-07
07613336172841CalSet DHEA-S II09043586190090435861902026-08-07
07613336217696Elecsys Tg II09744967190097449671902026-08-07
07613336217764Elecsys Anti-Tg09745602190097456021902026-08-07
07613336223321Kidney KFRE Algorithm09891986001098919860012025-03-31
07613336234457PreciControl Syphilis09465022190094650221902026-05-15
04015630913893AMYP Amylase EPS Pancreatic20766623322207666233222016-09-20
04015630910991alpha-Amylase liquid acc. to IFCC11876473316118764733162016-09-20
04015630911004Pancreatic alpha-amylase liquid11876562316118765623162016-09-20
04015630926848alpha-Amylase EPS Pancreatic540177119054017711902016-09-20
07613336121016a-Amylase EPS Pancreatic08056820190080568201902020-03-05
07613336171509Elecsys Calcitonin09005676190090056761902026-06-01
07613336171516CalSet Calcitonin09005684190090056841902026-06-01
07613336188064Elecsys Calcitonin09005668160090056681602026-06-01
07613336217641Elecsys Anti-TSHR09744819190097448191902026-06-01
07613336218341Elecsys CA 19-909755608190097556081902026-06-01
07613336218389Elecsys Estradiol III09755659190097556591902026-06-01

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