FDA.reportPublic FDA data

Alinity

Primary DI
00380740121662
Brand
Alinity
Company
Abbott GmbH
Model
08P1620
Catalog number
08P1620
Device description
Alinity c Urea Nitrogen Reagent Kit 4000 Tests
Published
2018-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CDQUREASE AND GLUTAMIC DEHYDROGENASE, UREA NITROGEN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CDQUrease And Glutamic Dehydrogenase, Urea NitrogenClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740121662PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740121662003807401216623807401216620380740121662

GMDN Terms#

Term, Definition table
TermDefinition
Urea 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 qualitative and/or quantitative detection of urea or urea nitrogen [also known as blood urea nitrogen (BUN)] in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity0 Percent (%) Relative Humidity0 Percent (%) Relative Humidity
Handling Environment Temperature030 Degrees Celsius
Storage Environment Humidity0 Percent (%) Relative Humidity0 Percent (%) Relative Humidity
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)422-2688xx@xx.xx

Regulatory Flags#

DUNS number
315786293
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00380740132552Alinity09P842009P84202023-11-16
00380740208622ARCHITECT4P52-2204P52222026-05-15
00380740208639Alinity08P432108P43212026-05-15
00380740193645ARCHITECT1P31-2701P31272026-04-28
00380740117207Alinity06P066006P06602019-10-12
00380740167455Alinity06P060306P06032019-10-12
00380740167462Alinity06P062006P06202019-10-12
00380740167479Alinity06P062406P06242019-10-12
00380740139032ARCHITECT06P222706P22272017-08-16
00380740139049ARCHITECT06P223706P22372017-08-16
00380740011130ARCHITECT6L23-0106L23012014-11-18
00380740189785Alinity09P262509P26252026-01-01
00380740189792ARCHITECT3P24-2803P24282026-01-01
00380740189808ARCHITECT3P24-3803P24382026-01-01
00380740189815Alinity09P263509P26352026-01-01
00380740189822Alinity09P260209P26022026-01-01
00380740189839Alinity09P261109P26112026-01-01
00380740189846ARCHITECT3P24-0203P24022026-01-01
00380740189853ARCHITECT3P24-1103P24112026-01-01
00380740223748Alinity09P261D09P261D2026-01-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414654119Atellica CH UN_cSiemens Healthcare Diagnostics Inc.CDQ2026-03-18
06944904084459Chemistry AnalyzerShenzhen Mindray Bio-Medical Electronics Co., Ltd.CDQ2026-01-23
10673486013580Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSCDQ2025-05-28
10673486013726Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSCDQ2025-05-28
10673486013894Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSCDQ2025-05-28
10673486013962Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSCDQ2025-05-28
00850053916069IDG/SanzayIDG/SANZAY CorporationCDQ2024-01-09
10673486001228Teco Diagnostics Urea Nitrogen (BUN) Liquid Reagent SetTECO DIAGNOSTICSCDQ2023-07-21
10673486001235Teco Diagnostics BUN (Urea) Reagent Kit TC Matrix-240/480TECO DIAGNOSTICSCDQ2023-07-21
10673486001242Teco Diagnostics Urea Nitrogen (BUN) Reagent SetTECO DIAGNOSTICSCDQ2023-07-21
10673486001259Teco Diagnostics Urea Nitrogen (BUN) Reagent SetTECO DIAGNOSTICSCDQ2023-07-21
00811727016058Pointe BUN ReagentHORIBA INSTRUMENTS INCORPORATEDCDQ2021-01-30
03610230007211Yumizen C1200 UreaHORIBA ABX SASCDQ2020-08-28
00811727015747Pointe BUN on BS480HORIBA INSTRUMENTS INCORPORATEDCDQ2020-05-28
07613336121603Urea/BunRoche Diagnostics GmbHCDQ2020-03-05
00380740161774ARCHITECTAbbott GmbHCDQ2020-01-25
00380740161781ARCHITECTAbbott GmbHCDQ2020-01-25
05055273216172UREARANDOX LABORATORIES LIMITEDCDQ2019-06-03
00386100001988BUN Reagent Kit MEDICA CORPORATIONCDQ2019-02-14
00380740121679AlinityAbbott GmbHCDQ2018-08-31
00852169008065ClearChem Diagnostics Inc. Blood Urea Nitrogen (BUN)CLEARCHEM DIAGNOSTICS INC.CDQ2018-04-30
00817274022672JAS DiagnosticsDREW SCIENTIFIC, INC.CDQ2018-04-26
00630414596471Atellica CH UN_cSiemens Healthcare Diagnostics Inc.CDQ2017-12-22
05060500091736Synermed®INFRARED LABORATORY SYSTEMS LLCCDQ2017-02-28
05060500091743Synermed®INFRARED LABORATORY SYSTEMS LLCCDQ2017-02-28
05060500091750Synermed®INFRARED LABORATORY SYSTEMS LLCCDQ2017-02-28
05060500091767Synermed®INFRARED LABORATORY SYSTEMS LLCCDQ2017-02-28
05060500091774Synermed®INFRARED LABORATORY SYSTEMS LLCCDQ2017-02-28
05060500091781Synermed®INFRARED LABORATORY SYSTEMS LLCCDQ2017-02-28
05060500091798Synermed®INFRARED LABORATORY SYSTEMS LLCCDQ2017-02-28